The United States Food and Drug Administration (FDA) is a federal agency responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and more. The FDA enforces safety standards, approves new products, monitors manufacturing processes, and responds to safety issues. Any foreign or domestic facility producing products intended for U.S. consumers must comply with FDA regulations.

A Food Facility Registration is required under the Food Safety Modernization Act (FSMA) for any domestic or foreign facility that manufactures, processes, packs, or holds food for U.S. consumption. The registration ensures the FDA can trace products back to their source in the event of a contamination or food safety emergency. Without registration, shipments may be detained or refused at the U.S. border.

A UFI (Unique Facility Identifier) is a number assigned by Dun & Bradstreet (DUNS) to verify the legitimacy of a facility in its country of operation. As of October 31, 2020, all domestic and foreign food facility registrations require a valid UFI. FDA Registration Assistance can help you obtain your DUNS number and include it in your registration submission.

Yes. All food products intended for U.S. sale must bear an FDA-compliant Nutrition Facts panel and ingredient list. The FDA has strict labeling requirements regarding font size, serving size, nutrient declarations, and allergen statements. Products that do not meet these requirements may be detained at the port of entry. We can assist in reviewing and formatting your food labels to meet FDA standards.

The Foreign Supplier Verification Program (FSVP) is a component of FSMA requiring U.S. importers to verify that their foreign suppliers produce food in compliance with FDA safety standards. Importers must conduct hazard analyses, review supplier performance, and maintain detailed records. Failure to have a proper FSVP plan can result in import refusals and regulatory action. We can help you develop a customized FSVP plan.

Food Facility Registrations must be renewed every two years during the even-numbered year renewal window (October 1 – December 31). Failing to renew on time means your registration becomes inactive and your products may be detained at U.S. ports of entry. FDA Registration Assistance provides renewal reminders and handles the entire renewal process on your behalf.

An FDA Import Alert places a manufacturer under automatic detention, meaning all shipments from that facility will be held at the U.S. border without physical examination. To be removed from the Import Alert list, a facility must typically provide five or more compliant shipments demonstrating corrective actions. We can guide you through the process of resolving an Import Alert and reinstating your import privileges.

Any domestic or foreign facility that manufactures, processes, packs, or holds human or animal food must register with the FDA. This includes facilities handling packaged foods, beverages, dietary supplements, food additives, and color additives. Restaurants, farms, and certain retail establishments may be exempt, but importers and manufacturers generally require registration. Contact us to determine whether your specific products require registration.

Yes. Facilities that manufacture, package, label, or hold dietary supplements are required to register as a food facility with the FDA and must also comply with Dietary Supplement Current Good Manufacturing Practices (cGMP) under 21 CFR Part 111. Additionally, manufacturers must submit New Dietary Ingredient (NDI) notifications for new ingredients. Labels must not make unauthorized drug claims. We can help you navigate all dietary supplement compliance requirements.

The FDA requires food labels to declare the presence of any of the nine major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame (added in 2023 under the FASTER Act). Allergens must be disclosed either within the ingredient list or in a separate "Contains" statement. Non-compliance can result in product recalls and import refusals. We can review your labels for full allergen compliance.

Prior Notice is a mandatory FDA requirement for all food shipments imported into the United States. It must be submitted electronically before the food arrives at a U.S. port of entry. It notifies the FDA of the incoming shipment so they can screen for potential safety issues. Failure to submit Prior Notice can result in refusal or detention of the shipment. Our team assists with Prior Notice submissions to ensure your products clear customs smoothly.

FDA Good Manufacturing Practices (GMPs) for food are outlined in 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food). They cover facility sanitation, employee hygiene, equipment design, production controls, and record-keeping. All registered food facilities must maintain GMP compliance to prevent contamination and ensure food safety. We provide guidance on achieving and maintaining GMP compliance.

Under FSMA's Preventive Controls for Human Food rule, covered facilities must have a Preventive Controls Qualified Individual (PCQI) to develop, validate, and manage the facility's food safety plan. A PCQI must have successfully completed FDA-recognized training or have equivalent job experience. We can connect you with qualified PCQIs or help identify the right training programs for your team.

Yes. The FDA has the authority to suspend a food facility registration if it determines that food manufactured at that facility has a reasonable probability of causing serious adverse health consequences. A suspended facility may not import or distribute food in the U.S. until the suspension is lifted. Voluntary cancellation is also possible if a facility closes or no longer handles food for U.S. consumption. We can assist in managing or reinstating your registration status.

The term "organic" is regulated by the USDA's National Organic Program (NOP), not the FDA. However, the FDA oversees the broader truthfulness of food labeling, and claims like "natural" are subject to FDA scrutiny. Misleading label claims can result in Warning Letters, import detentions, or recalls. We can help ensure your marketing claims align with both FDA and USDA requirements.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) requires domestic and foreign food facilities to register with the FDA and submit Prior Notice before importing food into the U.S. It gives the FDA authority to detain food it believes poses a serious threat to public health. All importers must maintain current registrations and submit timely Prior Notice to comply. We can help ensure all Bioterrorism Act obligations are consistently met.

Substances added to food must either be approved as food additives or be Generally Recognized as Safe (GRAS) under the conditions of their intended use. Manufacturers may voluntarily notify the FDA of a GRAS determination through the GRAS Notification Program. Without a valid GRAS status or food additive approval, an ingredient may be considered an unsafe additive. We can help assess whether your ingredients require a GRAS notice or food additive petition.

Food contact materials — such as packaging, containers, and coatings — are regulated by the FDA under indirect food additive regulations (21 CFR Parts 170–199). Any substance that migrates from the packaging into food must be approved or covered under a GRAS determination. Importers should ensure their packaging materials comply with FDA indirect food additive regulations to avoid detention. We can review your packaging materials for FDA compliance.

The FDA regulates bottled water as a packaged food product under the Federal Food, Drug, and Cosmetic Act. Bottled water must meet quality standards (21 CFR Part 165), be produced in registered facilities, and carry proper labeling. Standards of identity regulate the terms "spring water," "mineral water," "purified water," and others. Importers of bottled water must also register their facilities and comply with standard food import procedures. We can assist with registration and labeling compliance for bottled water products.

Under FSMA, registered food facilities are required to maintain records sufficient to identify the immediate previous source and immediate subsequent recipient of any article of food. Records must be kept for at least two years (six months for perishable items) and be made available to FDA inspectors upon request. Electronic records are acceptable. Inadequate recordkeeping is a common FDA inspection finding and can result in warning letters. We can help you develop and implement a recordkeeping program that satisfies FDA requirements.

Under FSMA's Preventive Controls rule, covered food facilities must develop and implement a written food safety plan that includes a hazard analysis, preventive controls, monitoring procedures, corrective actions, verification activities, and a recall plan. This HARPC-based approach replaces the older HACCP model for most non-seafood/juice facilities. The food safety plan must be prepared by a PCQI and reviewed every three years. We can help your facility develop and document a complete, audit-ready food safety plan.

Yes. Low-acid canned foods (LACF) and acidified foods have specific FDA regulations under 21 CFR Parts 108, 113, and 114. Manufacturers must register their processes with the FDA and submit process filings to a process authority before distributing the product. Inadequate processing of low-acid foods can result in Clostridium botulinum contamination, a serious public health risk. We can help you identify whether your product is subject to LACF regulations and assist with the required FDA process filings.

The USDA's National Bioengineered Food Disclosure Standard (NBFDS) — not the FDA — governs bioengineered (GMO) labeling for most foods. It requires disclosure of bioengineered ingredients through text, symbol, electronic/digital links, or text messages. The FDA provides guidance on GMO safety and labeling claims but does not administer the mandatory GMO disclosure program. However, FDA labeling standards still apply to all other aspects of the label. We can help you ensure your labels meet both USDA bioengineered disclosure and FDA requirements.

The FDA conducts both announced and unannounced inspections of food facilities. During an inspection, FDA investigators may review records, observe processes, collect samples, and issue a Form 483 listing any observations. Facilities should maintain organized records, train employees on FDA procedures, and ensure GMPs are consistently followed. A proactive readiness approach significantly reduces the risk of adverse inspection outcomes. We offer pre-inspection readiness assessments and mock FDA inspection preparation services.

If your food product is subject to an FDA-mandated recall, you must immediately notify all distributors and retail customers, remove the product from commerce, and submit a recall strategy and status reports to the FDA. Recalls are classified by risk level: Class I (serious health hazard), Class II (temporary health effects), and Class III (unlikely to cause harm). Maintaining a documented recall plan as part of your food safety program is an FDA requirement. We can help you develop a recall plan and manage the recall process from initiation through closure.

Yes. Any domestic or foreign establishment that manufactures, repacks, relabels, or distributes prescription or over-the-counter (OTC) drug products for the U.S. market must register with the FDA under 21 CFR Part 207. Registration must be renewed annually and a U.S. Agent is required for all foreign establishments. FDA Registration Assistance offers Drug Establishment Registration services starting at $449/year.

Yes. Hand sanitizers are classified as OTC drug products and their manufacturers must register with the FDA as a drug establishment. The registration creates accountability for formula accuracy, labeling compliance, and product safety. Both domestic and foreign manufacturers of hand sanitizers must maintain active FDA drug establishment registrations to legally sell their products in the United States. Contact us for fast and efficient registration support.

An NDC (National Drug Code) is a unique 10- or 11-digit identifier assigned to every drug product marketed in the United States. It is required on the label of all OTC and prescription drugs sold in the U.S. The NDC identifies the labeler, the product, and the package size. Drug products without a valid NDC cannot be legally marketed in the U.S. We can assist you in obtaining your NDC listing as part of your drug establishment registration.

A U.S. Agent is a person or company physically located in the United States who acts as the official point of contact between the FDA and a foreign drug establishment. U.S. Agents are required by law for all foreign drug manufacturers under 21 CFR 207.69. The agent must be reachable by the FDA during business hours. FDA Registration Assistance provides U.S. Agent services to help foreign manufacturers maintain compliance.

Both OTC and prescription drugs require drug establishment registration and drug listing. Prescription drugs additionally require an NDA or ANDA approved by the FDA before marketing. OTC drugs may be marketed under a final OTC monograph or through the OTC Drug Monograph Process. Both categories require cGMP compliance, proper labeling, and annual registration renewal. We can help determine the appropriate regulatory pathway for your specific product.

Current Good Manufacturing Practices (cGMP) for drugs are codified in 21 CFR Parts 210 and 211. They govern all aspects of pharmaceutical production including facility design, equipment qualification, raw material testing, manufacturing processes, quality control, and record-keeping. cGMP compliance is mandatory for all drug manufacturers supplying the U.S. market. Violations can result in Warning Letters, import bans, and consent decrees. We can help you prepare for cGMP compliance and FDA inspections.

The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical manufacturers, wholesalers, dispensers, and repackagers to track and trace prescription drug products through the supply chain. Electronic, interoperable tracing at the unit level is now required. DSCSA aims to prevent counterfeit, stolen, or contaminated drugs from entering the supply chain. Compliance requires implementing serialization and electronic exchange of transaction data. Contact us to learn how we can assist your company with DSCSA compliance.

Yes. Generic drug manufacturers must submit an Abbreviated New Drug Application (ANDA) to the FDA demonstrating that their product is bioequivalent to the reference listed drug (RLD). The ANDA must include data on formulation, manufacturing processes, labeling, and facility information. FDA approval is required before a generic drug can be marketed in the U.S. We can provide guidance on ANDA preparation and the FDA approval process.

FDA drug labeling requirements include the product's established name, ingredients, net quantity, name and address of the manufacturer, adequate directions for use, and warnings. OTC drug labels must include a Drug Facts panel in standardized format. Prescription drug labels must contain prescribing information (package insert). All labels must be in English and meet specific format requirements under 21 CFR Part 201. We can review your drug labels to ensure full FDA compliance before market entry.

An OTC Monograph is an FDA-issued document establishing the conditions under which a particular category of OTC drug is considered generally recognized as safe and effective (GRASE) without requiring individual pre-market approval. Manufacturers using monograph-compliant ingredients, formulations, and labeling can market their OTC products without a separate NDA. The CARES Act of 2020 modernized the OTC monograph process, transitioning to administrative orders. We can help confirm if your product qualifies under an existing monograph.

When the FDA initiates or requests a drug recall, the manufacturer must promptly notify all distributors and retailers, remove the product from commerce, and submit recall status reports to the FDA. Recalls are classified by severity: Class I (serious health hazard), Class II (temporary adverse health effects), and Class III (unlikely to cause harm). Effective recall procedures are part of cGMP requirements. We can help you develop recall strategies and prepare for mock recall audits.

Yes, depending on their activities. Traditional pharmacies compounding drugs for individual patients are primarily regulated by state pharmacy boards. However, "503B" outsourcing facilities that compound drugs in larger quantities are subject to FDA oversight under the Drug Quality and Security Act (DQSA). 503B facilities must register with the FDA, comply with cGMP, and submit adverse event reports. We can help compounding facilities navigate their specific compliance obligations.

A Drug Master File (DMF) is a voluntary submission to the FDA that provides confidential, detailed information about the manufacturing, processing, packaging, storage, or quality control of drug substances or components. DMFs are frequently referenced by drug product manufacturers in their NDA or ANDA submissions without disclosing proprietary information directly. Submission of a DMF is not an approval but serves as a reference document. We can help you prepare and submit a DMF to the FDA.

Yes. The FDA has authority to inspect both domestic and foreign drug manufacturing facilities. Foreign facility inspections may be conducted in person or via remote regulatory assessments. A Form 483 may be issued after an inspection identifying observations that need corrective action. Failure to adequately respond can lead to Warning Letters or import alerts. We help clients prepare for FDA inspections by conducting pre-inspection readiness assessments and gap analyses.

MedWatch is the FDA's Safety Information and Adverse Event Reporting Program. Drug manufacturers are required to report serious adverse events and product quality issues through MedWatch. Mandatory reporting applies to manufacturers for post-market safety data, while voluntary reporting is available to healthcare practitioners and consumers. We can assist you in establishing post-market surveillance procedures and adverse event reporting systems.

An Investigational New Drug (IND) application is a request for authorization from the FDA to administer an investigational drug or biological product to humans in clinical trials. Before any new drug can be tested on humans in the U.S., an IND must be submitted to and reviewed by the FDA. The IND includes preclinical data, manufacturing information, clinical protocols, and investigator information. We can guide sponsors through the IND submission process and help maintain compliance throughout clinical development.

A New Drug Application (NDA) is the formal mechanism through which a drug sponsor requests FDA approval to sell a new pharmaceutical product in the United States. The NDA must include all preclinical and clinical data, proposed labeling, manufacturing details, and safety information. The FDA typically has 10–12 months to review a standard NDA and 6 months for priority review. We can provide strategic guidance on NDA preparation, submission management, and FDA correspondence during the review process.

The FDA's Accelerated Approval pathway allows drugs for serious or life-threatening conditions to be approved based on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit, rather than waiting for definitive clinical outcomes data. Post-approval confirmatory trials are required to verify and describe actual clinical benefit. This pathway has been used for oncology drugs, HIV treatments, and rare disease therapies. We can assist in evaluating whether your drug candidate may qualify for Accelerated Approval and help you engage with the FDA early.

The FDA charges annual Prescription Drug User Fee Act (PDUFA) fees for certain drug manufacturers, but registration itself through FDA's SPL (Structured Product Labeling) system does not require a direct registration fee to the FDA. However, our agency service fee for Drug Establishment Registration is $449/year, which covers your registration submission, U.S. Agent service, and compliance monitoring. Registrations are due by December 31 of each year. We handle the entire process on your behalf so you never miss a deadline.

A pharmaceutical import alert results in automatic detention of drug products from a specific manufacturer at U.S. ports of entry. Common causes include cGMP violations, failed inspections, lack of registration, or unresolved Warning Letters. To be removed, a facility must demonstrate sufficient corrective actions through documentation, third-party audits, and in some cases, a successful FDA re-inspection. The process can take months to years. We help clients develop corrective action plans and manage the removal petition process.

FDA requires stability testing data to support the proposed shelf life and storage conditions of drug products. Stability studies must be conducted under ICH guidelines (Q1A–Q1F) using samples from at least three production-scale batches. Testing must continue throughout the product's commercial life, and any out-of-specification results must be investigated. Stability data is a critical component of NDA and ANDA submissions. We can help you design stability programs that meet FDA and ICH requirements.

Yes. In the United States, sunscreens are regulated as OTC drug products, not cosmetics. Sunscreen manufacturers must register as drug establishments, list their products with the FDA, use only FDA-approved active ingredients (e.g., zinc oxide, titanium dioxide), and comply with the OTC Sunscreen monograph regulations. In 2019, the FDA proposed updated sunscreen regulations requiring additional safety data for several active ingredients. We can help sunscreen manufacturers achieve and maintain full OTC drug compliance.

A Citizen Petition is a formal submission requesting the FDA to take or refrain from taking a specific regulatory action. In the pharmaceutical context, they are commonly filed to delay or block approval of a competing generic drug by raising safety or scientific concerns. The FDA is required to respond within 180 days. They can also be used to request monograph changes or labeling updates. We can advise on the strategic use of Citizen Petitions and assist with their preparation and submission.

The FDA's Fast Track designation is designed to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. Benefits include more frequent meetings and communications with the FDA, rolling review (submitting completed sections of the NDA before the entire application is complete), and eligibility for Priority Review and Accelerated Approval. Sponsors can request Fast Track designation at any time during drug development. We can help assess eligibility and prepare Fast Track designation requests.

Biological drug products — including vaccines, blood products, gene therapies, and monoclonal antibodies — are regulated by the FDA's Center for Biologics Evaluation and Research (CBER) or Center for Drug Evaluation and Research (CDER), depending on the product type. Biologics require a Biologics License Application (BLA) rather than an NDA for market approval. Biosimilar products (similar to approved biologics) require abbreviated pathways under the Biologics Price Competition and Innovation Act (BPCIA). We provide strategic regulatory consulting for biologics and biosimilar development programs.

Any domestic or foreign facility that manufactures, repackages, relabels, or imports medical devices for U.S. commercial distribution must register with the FDA. Registration is done through the FDA's FURLS database and must be renewed annually. A U.S. Agent is required for all foreign establishments. We provide full device establishment registration services including annual renewals and ongoing compliance support.

The FDA classifies medical devices into three classes based on risk: Class I devices pose minimal risk (e.g., bandages) and are primarily subject to general controls. Class II devices pose moderate risk (e.g., blood pressure monitors) and often require a 510(k) clearance. Class III devices pose the highest risk (e.g., implantable pacemakers) and typically require a Pre-Market Approval (PMA). Correct classification determines the regulatory pathway for your device.

A 510(k) is a premarket notification submitted to the FDA demonstrating that your device is substantially equivalent to a legally marketed predicate device. Most Class II devices require 510(k) clearance before they can be sold in the U.S. The submission includes device description, performance testing data, labeling, and comparison to a predicate. FDA typically reviews 510(k)s within 90 days. We can help prepare and submit your 510(k) to the FDA.

A Pre-Market Approval (PMA) is the FDA's most stringent device marketing authorization, required for Class III devices. A PMA requires valid scientific evidence — typically clinical trials — demonstrating the device's safety and effectiveness. The FDA review process can take 180 days or longer. We can help guide device manufacturers through PMA strategy development and submission preparation.

A Unique Device Identifier (UDI) is a code placed on the device label and packaging allowing adequate identification through distribution and use. UDI compliance is mandatory for most medical devices sold in the U.S. and involves labeling with both a Device Identifier (DI) and Production Identifier (PI). Device information must also be submitted to the FDA's GUDID database. We help manufacturers achieve UDI compliance and register their devices in GUDID.

The De Novo pathway allows novel, low-to-moderate risk devices that lack a predicate for a 510(k) to be classified as Class I or Class II. If granted, the device itself becomes a predicate for future 510(k) submissions. The requester must demonstrate that general or special controls are sufficient to provide reasonable assurance of the device's safety and effectiveness. FDA review generally takes 150 days. We can assess whether De Novo is appropriate for your device and assist with the submission.

A Quality Management System (QMS) is a structured framework of processes required under 21 CFR Part 820 (Quality System Regulation), governing design controls, document management, production controls, CAPA, complaint handling, and record retention. The FDA is transitioning 21 CFR Part 820 to align with ISO 13485:2016. All registered medical device manufacturers must maintain a compliant QMS. We can help you develop and implement a QMS tailored to your operations.

Medical device labels must include the device's intended use, directions for use, contraindications, warnings, and the manufacturer's name and address. Labels must also include the UDI and in some cases an expiration date or lot number. Labels for prescription devices must state "Caution: Federal law restricts this device to sale by or on the order of a physician." We can review your device labeling for full FDA compliance.

An FDA Medical Device Import Alert places a facility or product under automatic detention at U.S. ports of entry. Import alerts may be issued for lack of registration, uncleared devices, cGMP violations, labeling deficiencies, or fraud. Removal requires demonstrating corrective actions to the FDA's satisfaction. We can help you develop a corrective action plan and petition for removal from the import alert list.

Yes. Combination products — such as prefilled syringes or drug-eluting stents — combine a drug, device, or biological component and are regulated by the FDA's Office of Combination Products (OCP). The OCP determines the primary mode of action and assigns regulatory oversight to CDER, CDRH, or CBER accordingly. Both drug and device regulations may apply depending on the product's classification. We can help navigate this complex regulatory landscape.

A medical device recall is an action taken to address a problem with a device that violates FDA law. Recalls may be initiated voluntarily or requested by the FDA. All recalls must be reported to the FDA, and manufacturers must develop a recall strategy, notify affected parties, and submit periodic status reports. The FDA classifies recalls based on health risk (Class I, II, or III). We can help you establish recall procedures and respond effectively to FDA recall requests.

A Medical Device Report (MDR) is a mandatory post-market safety report required by the FDA under 21 CFR Part 803 when a device may have caused or contributed to a serious injury, death, or malfunction. Manufacturers must submit reports within 30 days (or 5 days for urgent cases) of becoming aware of the event. We can assist you in developing an MDR reporting program and maintaining compliance with post-market surveillance obligations.

The FDA's Breakthrough Device Designation provides an expedited review pathway for devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. Benefits include early and frequent FDA interaction, prioritized review, and potential for early manufacturing site inspections. We can help evaluate whether your device qualifies for this designation and assist with the application process.

In vitro diagnostic (IVD) devices — including test kits, reagents, and laboratory instruments used to diagnose diseases — are regulated as medical devices by CDRH. They require appropriate clearance or approval (510(k), PMA, or De Novo), device listing, establishment registration, and QSR compliance. High-complexity IVDs used in clinical labs may also fall under CLIA regulations. We can help you determine the right regulatory pathway for your IVD product.

Yes. Software as a Medical Device (SaMD) — software that performs a medical function without being part of a hardware device — is regulated by the FDA under device regulations. Examples include AI-based diagnostic tools and clinical decision support software. SaMD products may require 510(k) clearance, De Novo, or PMA depending on risk level. We can assess your SaMD's regulatory requirements and develop a compliant submission strategy.

Medical devices that contact patients must be sterile or have a defined bioburden level as appropriate for their intended use. The FDA's QSR requires that device manufacturers develop and validate sterilization methods (e.g., ethylene oxide, radiation, steam) in accordance with recognized standards such as ISO 11135 and ISO 11137. Sterilization validation data must be included in premarket submissions for sterile devices. We can help you review your sterilization validation approach for FDA compliance.

After an FDA inspection of a medical device facility, the investigator may issue a Form 483 with observations. The manufacturer should respond in writing within 15 business days, outlining corrective actions. The FDA then issues an Establishment Inspection Report (EIR) summarizing the findings and the agency's classification of the inspection (NAI, VAI, or OAI). An Official Action Indicated (OAI) classification can lead to a Warning Letter or import alert. We help clients prepare responses to Form 483 observations and manage post-inspection corrective action plans.

The Humanitarian Device Exemption (HDE) is a marketing authorization for Humanitarian Use Devices (HUDs) — devices intended to treat or diagnose diseases affecting fewer than 8,000 individuals per year in the U.S. The HDE exempts the device from demonstrating effectiveness, requiring only a probable benefit that outweighs the risks. Use of HUDs in non-pediatric populations requires IRB approval. This pathway is ideal for rare disease devices where large clinical trials are impractical. We can help evaluate HDE eligibility and assist with the submission.

CAPA (Corrective and Preventive Action) is a core QMS requirement under 21 CFR Part 820. Corrective actions address the root cause of existing nonconformities or defects, while preventive actions address potential problems before they occur. CAPA systems must be documented, data-driven, and verified for effectiveness. Failure to maintain an effective CAPA system is one of the most frequently cited FDA inspection observations. We can help you design and implement a robust CAPA system that satisfies FDA expectations.

It depends on the intended use and the claims made. General wellness devices that promote a healthy lifestyle without making disease-related claims are typically not regulated as medical devices. However, if a wearable makes specific diagnostic or therapeutic claims (e.g., "detects atrial fibrillation"), it likely requires FDA clearance. The FDA's Digital Health Center of Excellence has issued guidance on this topic. We can review your device's intended use and marketing claims to determine its regulatory status.

MDUFA (Medical Device User Fee Amendments) establishes fees paid by medical device manufacturers when submitting premarket applications such as 510(k)s, PMAs, and De Novo requests. These fees fund the FDA's device review activities and are reauthorized by Congress every five years. Small businesses may be eligible for fee reductions or waivers. Fees vary by submission type and are updated annually. We can help determine applicable fees for your submission and advise on small business qualification for fee reductions.

Post-market surveillance (PMS) for medical devices includes MDR reporting, complaint handling, CAPA, periodic safety update reports for certain Class II and III devices, and post-approval studies when required by the FDA as a condition of PMA approval. The FDA may also order a 522 Post-Market Surveillance Study for certain Class II or III devices. Effective PMS systems help identify safety issues early and demonstrate ongoing compliance. We can help you develop or strengthen your post-market surveillance program.

The FDA has issued cybersecurity guidance (most recently updated in 2023) requiring medical device manufacturers to incorporate cybersecurity into their design, development, and post-market processes. For 510(k), De Novo, and PMA submissions, manufacturers must include a Software Bill of Materials (SBOM), cybersecurity risk assessment, and a coordinated vulnerability disclosure plan. The Omnibus Appropriations Act of 2023 codified cybersecurity requirements into law. We can help your team understand and implement these requirements for connected medical devices.

Reprocessors of single-use devices (SUDs) are treated as manufacturers under FDA regulations and must register as device establishments, submit appropriate premarket notifications (510(k) or PMA), follow QSR, and label reprocessed devices with their name and address. The Medical Device User Fee and Modernization Act (MDUFMA) created this framework to ensure reprocessed SUDs meet the same safety standards as original devices. We can help SUD reprocessors understand and fulfill their FDA regulatory obligations.

An FDA device Warning Letter is a formal notification that a company has violated device regulations. Companies must respond within 15 business days, addressing each cited violation with specific corrective actions and timelines. Warning Letters are publicly posted on the FDA's website and can impact business relationships and regulatory standing. Ignoring a Warning Letter may result in injunctions, seizures, or import alerts. We have extensive experience helping companies draft effective Warning Letter responses and implement lasting corrective measures.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most significant update to U.S. cosmetic regulations since 1938. MoCRA requires mandatory facility registration and product listing, substantiation of product safety, serious adverse event reporting, compliance with GMP regulations, and responsible person accountability. All cosmetic manufacturers and importers selling to the U.S. market must comply. We can help you navigate this new regulatory framework.

Yes. Under MoCRA, all domestic and foreign facilities that manufacture or process cosmetic products for U.S. distribution must register with the FDA biennially (every two years). Any changes to facility information must be updated within 60 days. Small businesses under $1 million in average annual gross sales may have certain exemptions, but many still need to register. We offer complete MoCRA cosmetic facility registration services.

Under the FD&C Act, cosmetics are articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance. Common examples include skincare products, makeup, perfumes, nail polish, shampoos, and deodorants. However, a product making drug claims (e.g., anti-aging, whitening, acne treatment) may be classified as a drug and subject to additional requirements. Proper classification is critical before entering the U.S. market.

Yes. Under MoCRA, the responsible person must submit a product listing to the FDA for each cosmetic product marketed in the U.S. The listing must include the product name, applicable cosmetic category, list of ingredients, and facility information. Listings must be updated annually and whenever new products are introduced. We provide comprehensive cosmetic product listing services to ensure your products are fully compliant with MoCRA.

FDA cosmetic labeling requirements include: the identity of the product, net quantity of contents, distributor or manufacturer name and address, and ingredient declaration listing all ingredients in descending order of predominance using INCI names. Labels must be in English and use minimum font sizes. MoCRA also requires disclosure of fragrance allergens at specified thresholds. We can review your cosmetic labels to confirm they meet all FDA requirements.

Cosmetics affect appearance without altering the body's structure or function, while drugs are intended to prevent, treat, cure, or mitigate disease, or affect the body's structure or function. Products like sunscreens, anti-dandruff shampoos, and fluoride toothpastes are regulated as both cosmetics and OTC drugs. Marketing claims can determine which category a product falls into — making careful label review essential. We can help classify your product correctly.

Yes. The FDA prohibits or restricts certain ingredients in cosmetics sold in the U.S., including mercury compounds, hexachlorophene, halogenated salicylanilides, chloroform, and vinyl chloride. Color additives must be FDA-approved. Under MoCRA, the FDA now has the authority to issue regulations prohibiting or restricting cosmetic ingredients. We can review your formulations to verify ingredient compliance before entering the U.S. market.

Under MoCRA, responsible persons must report serious adverse events associated with cosmetic products to the FDA within 15 business days. A serious adverse event includes death, life-threatening experiences, hospitalization, persistent disability, congenital anomaly, or medical/surgical intervention. Records of all adverse events must be maintained for six years. We can help you develop adverse event monitoring and reporting procedures compliant with MoCRA.

MoCRA directs the FDA to establish cosmetic GMP regulations taking ISO 22716:2007 into account. These regulations will address personnel, buildings and facilities, equipment, raw materials, production, laboratory controls, internal audits, and documentation. While GMP regulations are being finalized, manufacturers are strongly encouraged to follow ISO 22716 now. We can help you assess your current manufacturing practices and implement the necessary improvements ahead of the final rules.

Yes. Under MoCRA, foreign cosmetic facilities required to register with the FDA must designate a U.S. Agent physically located in the United States to serve as the primary FDA contact. The U.S. Agent must be available during normal business hours to respond to FDA communications. FDA Registration Assistance provides U.S. Agent services specifically for cosmetic manufacturers and importers.

Cosmetics may make appearance-related claims such as "reduces the appearance of wrinkles." However, claims that affect the body's structure or function — such as "stimulates collagen production" or "repairs DNA" — may cause the FDA to classify the product as a drug requiring pre-market approval. Marketing claims must stay within cosmetic boundaries. We can review your product claims and marketing materials to reduce regulatory risk.

All color additives used in cosmetics sold in the U.S. must be approved by the FDA and listed in 21 CFR Parts 73, 74, and 82. Some color additives require batch certification before use. Color additives approved in other countries may not be approved in the U.S., making a careful review of formulations essential. Using non-approved color additives can result in product detention or refusal at the U.S. border. We can review your cosmetic formulations for color additive compliance.

The FDA does not regulate or define "cruelty-free" or "vegan" claims for cosmetic products. These claims are voluntary and not subject to FDA pre-approval. However, all label claims must be truthful and not misleading per the FTC's guidelines and FD&C Act. Third-party certifications for "cruelty-free" and "vegan" can enhance consumer trust. We can advise you on presenting these claims in a marketable and compliant manner.

Cosmetics intended for children are subject to the same general labeling and safety regulations as all other cosmetics. However, the FDA applies extra scrutiny to products marketed for children due to their increased vulnerability to certain ingredients. Under MoCRA's safety substantiation requirement, all cosmetics — including those for children — must have adequate safety substantiation before marketing. We can help with safety substantiation documentation for children's cosmetics.

An FDA Warning Letter is a serious communication indicating a company has violated applicable laws or regulations. Upon receipt, you must submit a written response within the timeframe specified (usually 15 business days), addressing each violation cited and outlining corrective actions. Ignoring a Warning Letter can result in seizure, injunction, or import refusal. FDA Registration Assistance has extensive experience responding to FDA Warning Letters and can help you craft an effective, compliant response strategy.

Under MoCRA, the "responsible person" is the manufacturer, packer, or distributor whose name appears on the cosmetic product label. The responsible person is accountable for product listing submissions, safety substantiation, adverse event reporting, and maintaining records. Importers of foreign cosmetics are generally considered the responsible person for products entering the U.S. market. Understanding and fulfilling these obligations is essential for compliance. We can help you identify your role as a responsible person and manage your MoCRA obligations efficiently.

Yes, though with some scaled obligations. MoCRA defines "small businesses" as those with average annual gross sales of cosmetics in the U.S. under $1 million over the past three years. Small businesses have extended compliance timelines and may be exempt from certain facility registration requirements, but product listing obligations and safety substantiation still apply. Very small businesses (under $100,000 in annual sales) have the most limited obligations. We can assess exactly which MoCRA requirements apply to your business size and help you comply efficiently.

MoCRA requires that all cosmetic products have adequate substantiation of safety before marketing. This means maintaining records that demonstrate each product and its ingredients are safe for their intended use. Substantiation may include ingredient safety data, finished product safety assessments, stability testing, and dermatological evaluations. While the FDA has not yet specified a precise format, following international standards (e.g., ISO 29621 for preservative efficacy, ISO 10993 principles) is recommended. We can help you develop and document a robust safety substantiation file for each of your cosmetic products.

MoCRA includes provisions requiring the FDA to issue regulations for the disclosure of fragrance allergens on cosmetic labels. Under existing FDA regulations, cosmetic ingredients must be listed on labels, but fragrances have historically been allowed to be listed simply as "fragrance" or "parfum." MoCRA's fragrance allergen disclosure requirement will add specificity for certain allergens at or above defined concentration thresholds. We monitor regulatory developments and can help you prepare for fragrance disclosure compliance as the FDA finalizes these rules.

One of the most significant changes under MoCRA is that the FDA now has mandatory recall authority over cosmetic products — something it previously lacked. If the FDA determines that a cosmetic product presents a reasonable probability of serious adverse health consequences, it can order a mandatory recall. Previously, cosmetic recalls were entirely voluntary. Responsible persons must maintain systems to respond to recalls promptly and effectively. We can help you develop a recall readiness plan tailored to your cosmetic product portfolio.

Foreign cosmetic products imported into the U.S. must comply with all applicable FDA regulations, including proper labeling in English, use of only permitted ingredients, facility registration under MoCRA, product listing, and safety substantiation. Shipments that do not meet FDA requirements may be detained or refused at the port of entry. The importer of record is typically considered the responsible person for compliance purposes. We help international cosmetic brands navigate the complete U.S. market entry process.

Not necessarily. The FDA and EU cosmetics regulations differ significantly. The EU bans or restricts over 1,300 cosmetic ingredients, while the FDA has historically banned fewer. However, some ingredients approved in the EU are not yet evaluated or permitted by the FDA, particularly newer synthetic materials or certain novel actives. Color additives must always be explicitly approved by the FDA regardless of their EU status. We can perform a regulatory gap analysis of your formulation to identify any ingredients that may be problematic for U.S. market entry.

MoCRA's requirements apply to cosmetic products regardless of whether they are sold to consumers or used professionally in salons, spas, or barbershops. Facility registration, product listing, safety substantiation, adverse event reporting, and GMP compliance obligations apply equally to manufacturers and distributors of professional-use cosmetics. Products with higher-concentration active ingredients may warrant additional safety evaluation. We can help professional cosmetic manufacturers and importers understand and meet all their MoCRA obligations.

Yes, indirectly. The FDA monitors online marketing claims, including those made on social media. If paid influencers or brand representatives make drug-like claims about a cosmetic product (e.g., "cures eczema," "eliminates acne"), those claims can be attributed to the brand and may cause the FDA to regulate the product as a drug. The FTC also oversees endorsement disclosures. Companies should carefully train their marketing teams and influencer partners on permissible cosmetic claims. We can review your social media marketing strategy and provide claim guidance to minimize regulatory risk.

MoCRA was signed into law on December 29, 2022. Key implementation timelines include: facility registration opened December 29, 2023 (large businesses) and July 1, 2024 (small businesses); product listing was required simultaneously with registration; serious adverse event reporting became effective December 29, 2023; and GMP regulations are expected to be finalized within 2 years of enactment. Additional rulemaking on fragrance allergen disclosure and other provisions continues. Staying current with MoCRA deadlines is critical. We actively track FDA rulemaking and can help you meet every compliance milestone on time.