Question 1

What is FDA and what does it regulate?

Accepted Answer

The Food and Drug Administration (FDA) is a federal agency within the US Department of Health and Human Services. FDA regulates food, drugs, medical devices, cosmetics, tobacco products, and radiation-emitting products. For FDA-regulated products entering the US market, companies must comply with various registration, listing, labeling, and manufacturing requirements depending on the product type.

Question 2

Do I need FDA approval to sell products in the US?

Accepted Answer

It depends on the product type. Prescription drugs and Class III medical devices require FDA approval before marketing. However, most foods, dietary supplements, cosmetics, OTC drugs (under monographs), and Class I/II medical devices do not require pre-market approval. Instead, these products must comply with registration, listing, labeling, and manufacturing (GMP) requirements. FDA can take action against non-compliant products after they enter the market.

Question 3

What is FDA facility registration?

Accepted Answer

FDA facility registration is the process of registering your manufacturing, processing, packing, or holding facility with FDA. Requirements vary by product type: food facilities must register biennially (every 2 years), drug and device establishments must register annually, and cosmetic facilities must register under MoCRA. Registration provides FDA with information about who is manufacturing regulated products and where they are located.

Question 4

What is the difference between registration and listing?

Accepted Answer

Registration identifies your facility/establishment with FDA, while listing identifies the specific products you manufacture or distribute. For example, a drug establishment registers once annually but must list each drug product separately with its NDC number. Similarly, food facilities register but may need to list low-acid canned foods separately. Both are typically required for FDA compliance.

Question 5

How often must I renew my FDA registration?

Accepted Answer

Renewal frequency depends on product type: Food facilities must renew biennially (every 2 years) during October 1 - December 31 of even-numbered years. Drug and medical device establishments must register annually during October 1 - December 31. Cosmetic facilities under MoCRA must renew biennially. Failure to renew results in cancellation of your registration.

Question 6

What happens if I don't register with FDA?

Accepted Answer

Operating without proper FDA registration can result in serious consequences: imported products may be detained or refused entry at US ports, FDA may issue warning letters, products may be seized, and in severe cases, criminal prosecution is possible. Additionally, your products cannot legally be sold in US commerce without proper registration.

Question 7

What is a DUNS number and why do I need it?

Accepted Answer

A DUNS (Data Universal Numbering System) number is a unique nine-digit identifier for businesses issued by Dun & Bradstreet. FDA requires a DUNS number for facility registration for foods, drugs, devices, and cosmetics. The DUNS number helps FDA identify and track registered facilities. You can obtain a free DUNS number from Dun & Bradstreet's website.

Question 8

What is cGMP and does it apply to my products?

Accepted Answer

Current Good Manufacturing Practice (cGMP) refers to FDA regulations that establish minimum requirements for manufacturing methods, facilities, and controls. cGMP applies to drugs (21 CFR 210/211), medical devices (21 CFR 820 - QSR), and dietary supplements (21 CFR 111). Foods must follow preventive controls under FSMA. Cosmetics will have GMP requirements under MoCRA. cGMP ensures products are consistently produced and controlled according to quality standards.

Question 9

How do I know which FDA requirements apply to my product?

Accepted Answer

Start by determining your product's FDA classification: Is it a food, drug, medical device, cosmetic, or dietary supplement? Some products may be regulated as multiple categories (e.g., medicated cosmetics, combination products). Once classified, identify applicable requirements for registration, listing, labeling, manufacturing, and any premarket submissions. Our free Compliance Calculator can help determine your specific requirements.

Question 10

What is an FDA inspection and how do I prepare?

Accepted Answer

FDA inspections are on-site reviews of facilities to verify compliance with regulations. Inspectors examine records, observe operations, interview staff, and may collect samples. To prepare: ensure documentation is current and accessible, train staff on their responsibilities, conduct internal audits, review recent FDA 483s in your industry, and have a designated person to accompany inspectors. Respond to any findings promptly and thoroughly.

Question 11

What is Form FDA 483?

Accepted Answer

Form FDA 483 is issued at the end of an FDA inspection to communicate observations of conditions that may violate FDA regulations. It's not a final determination of violation but identifies concerns. You have 15 business days to respond in writing, addressing each observation with corrective actions. Failure to adequately respond can result in warning letters or other enforcement actions.

Question 12

What is an FDA Warning Letter?

Accepted Answer

A Warning Letter is an official FDA communication notifying a company of significant regulatory violations that require prompt correction. It's issued when FDA believes violations are serious enough to warrant enforcement action if not corrected. Companies typically have 15 business days to respond with a corrective action plan. Warning letters are public record and can damage reputation, affect imports, and lead to further enforcement.

Question 13

Can FDA recall my products?

Accepted Answer

Yes, FDA has recall authority that varies by product type. For drugs and devices, FDA can request voluntary recalls and mandate recalls in certain situations. Under MoCRA, FDA can mandate cosmetic recalls. For foods, FDA can mandate recalls under FSMA if a company doesn't voluntarily recall. Most recalls are voluntary, initiated by companies. FDA classifies recalls by health risk: Class I (serious), Class II (temporary/reversible), Class III (unlikely harm).

Question 14

How do I report adverse events to FDA?

Accepted Answer

Adverse event reporting requirements vary by product: Drugs/biologics - MedWatch (serious events within 15 days); Medical devices - MDR system (deaths/serious injuries within 30 days, 5 days for emergencies); Dietary supplements - serious adverse events within 15 business days; Cosmetics - serious adverse events within 15 business days under MoCRA; Foods - voluntary reporting encouraged. Keep records of all adverse events.

Question 15

What resources does FDA provide for compliance help?

Accepted Answer

FDA offers numerous resources: Small Business & Industry Assistance (SBIA) programs, guidance documents, webinars, and the FDA website with regulations and compliance guides. CDER, CDRH, CFSAN, and OFRA have dedicated small business offices. FDA also has pre-submission meetings for drugs and devices. Additionally, private compliance consultants like Assurentry can provide personalized guidance.

Question 16

Who must register their food facility with FDA?

Accepted Answer

Domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the US must register with FDA. This includes facilities making dietary supplements. Exemptions include: farms, retail food establishments, restaurants, nonprofit food establishments, fishing vessels, and facilities regulated exclusively by USDA. Private residences are also exempt.

Question 17

How do I register my food facility with FDA?

Accepted Answer

Food facility registration is done electronically through FDA's Food Facility Registration Module (FFRM) at https://www.access.fda.gov. You'll need a DUNS number and, for foreign facilities, a US Agent. Registration is free. You'll receive a registration number upon successful submission. Keep your login credentials secure as you'll need them for biennial renewals and updates.

Question 18

When must I renew my food facility registration?

Accepted Answer

Food facility registration must be renewed biennially (every two years) during the period of October 1 through December 31 of even-numbered years (2024, 2026, 2028, etc.). FDA sends email reminders if you've provided an email address. Failure to renew by December 31 results in automatic cancellation of your registration, and food from that facility cannot legally enter US commerce.

Question 19

What is a food facility registration number?

Accepted Answer

Upon successful registration, FDA assigns a unique 11-digit Food Facility Registration Number (FFR#). This number identifies your facility in FDA's system and is required for Prior Notice filings when importing food. The number remains the same through renewals unless the facility's ownership or location changes significantly. Keep this number accessible for import documentation.

Question 20

Do I need to update my food facility registration?

Accepted Answer

Yes, you must update your registration within 60 days if there are changes to: facility name, address, or contact information; trade names; types of food activities; US Agent information (for foreign facilities); or emergency contact. Updates between renewal periods don't extend the registration - you still must renew during the normal biennial period.

Question 21

What food categories must I select during registration?

Accepted Answer

During registration, you must identify all food product categories your facility handles using FDA's food category codes. Categories include: dairy, eggs, seafood, fruits/vegetables, grains, beverages, snacks, dietary supplements, animal food, etc. Accurate selection is important as it affects inspection priority and helps FDA contact you during relevant food safety issues.

Question 22

Is food facility registration free?

Accepted Answer

Yes, FDA food facility registration is free. There are no government fees to register, renew, or update your food facility registration. However, you may incur costs for a US Agent (required for foreign facilities) or for professional assistance with registration. Be wary of third parties charging excessive fees for what is a free government registration.

Question 23

What is the difference between FDA and USDA registration?

Accepted Answer

FDA and USDA regulate different food products. USDA regulates meat, poultry, and egg products under the Federal Meat Inspection Act and Poultry Products Inspection Act. FDA regulates all other foods including seafood, dairy, produce, packaged foods, and dietary supplements. Some facilities may need both FDA registration and USDA inspection if they handle both FDA and USDA-regulated products.

Question 24

Can my registration be suspended or cancelled?

Accepted Answer

Yes. FDA can suspend a food facility registration if it determines food from that facility has a reasonable probability of causing serious adverse health consequences. Suspended facilities cannot distribute food until the suspension is lifted. Registration is also cancelled automatically if you fail to renew during the biennial renewal period. You can voluntarily cancel registration if your facility no longer requires it.

Question 25

What is LACF registration?

Accepted Answer

Low-Acid Canned Food (LACF) registration is separate from food facility registration. Facilities that manufacture low-acid canned foods or acidified foods must file FDA Form 2541 (Food Canning Establishment Registration) and FDA Form 2541a or 2541c (Scheduled Process Filing) for each product. This is required in addition to standard food facility registration due to the botulism risk in these products.

Question 26

Do farmers need to register with FDA?

Accepted Answer

Generally, farms are exempt from FDA food facility registration. However, the exemption only applies to facilities in one location devoted to growing, harvesting, or raising crops/animals. If a farm also manufactures, processes, packs, or holds food beyond what's typically done on a farm (minimal processing), it may need to register. Mixed-type facilities need careful evaluation.

Question 27

What records must food facilities maintain?

Accepted Answer

Food facilities must maintain records required by applicable regulations including: records identifying immediate previous sources and recipients (one-up, one-back traceability), FSMA preventive controls records, HACCP records if applicable, and any product-specific requirements. Records must generally be available to FDA within 24 hours of request. Electronic records are acceptable if they meet 21 CFR Part 11 requirements.

Question 28

Who must register as a drug establishment?

Accepted Answer

All domestic and foreign establishments that manufacture, prepare, propagate, compound, or process drugs for distribution in the US must register with FDA. This includes manufacturers of finished dosage forms, active pharmaceutical ingredients (APIs), repackagers, relabelers, and drug product salvagers. Contract manufacturers must register even if they don't market products under their own name.

Question 29

What is a drug establishment registration fee?

Accepted Answer

FDA charges an annual establishment fee under the Prescription Drug User Fee Act (PDUFA). For FY 2024, the fee is approximately $73,488 per establishment. Small businesses may qualify for reduced fees or fee waivers. The fee is due at time of initial registration and upon each annual re-registration. Foreign and domestic establishments pay the same fees.

Question 30

When is the drug establishment registration period?

Accepted Answer

Drug establishments must register annually between October 1 and December 31 for the following calendar year. New establishments must register within 5 days of beginning operations. Updates to existing registrations must be made within 30 days of any changes. Unlike food registration, drug registration is annual, not biennial.

Question 31

What is drug listing and when is it required?

Accepted Answer

Drug listing identifies each commercially distributed drug product with FDA. All drugs must be listed, including prescription, OTC, and homeopathic drugs. Initial listing must be done within 5 days of beginning commercial distribution. Updates must be submitted in June and December (or within 5 days of changes). Each drug is listed with its NDC number, labeling, and ingredient information.

Question 32

How do I obtain an NDC number?

Accepted Answer

NDC numbers have three segments: labeler code (assigned by FDA during registration), product code (you assign), and package code (you assign). You receive your labeler code after successful FDA registration. Then you create product and package codes following FDA's format rules (4-4-2, 5-3-2, or 5-4-1). The complete NDC is used in drug listing, labeling, and for billing/claims.

Question 33

Do OTC drug manufacturers need to register?

Accepted Answer

Yes, OTC drug manufacturers must register and list their products just like prescription drug manufacturers. If your OTC drug conforms to an applicable monograph, you don't need pre-market approval, but registration, listing, and cGMP compliance are still required. The annual establishment fee also applies.

Question 34

What is an OTC drug monograph?

Accepted Answer

OTC drug monographs are FDA regulations specifying acceptable active ingredients, doses, formulations, and labeling for categories of OTC drugs. If your product conforms to an applicable monograph (e.g., antacid, sunscreen, first aid antibiotic), it can be marketed without NDA approval. Products not covered by monographs need an NDA or must use the OTC Monograph Reform process.

Question 35

What is Structured Product Labeling (SPL)?

Accepted Answer

SPL is an XML-based document format required for submitting drug labeling information to FDA. All drug establishments must submit establishment registration and drug listing information using SPL. Drug labeling (package inserts, medication guides) must also be submitted in SPL format. Many companies use SPL authoring software or services to create compliant submissions.

Question 36

Do API manufacturers need to register?

Accepted Answer

Yes, manufacturers of active pharmaceutical ingredients (APIs) or bulk drug substances must register with FDA as drug establishments. They must also list each API they produce. API manufacturers are subject to cGMP requirements under 21 CFR Parts 210 and 211 (or ICH Q7 for APIs). Foreign API manufacturers must designate a US Agent.

Question 37

What is a contract manufacturer's registration obligation?

Accepted Answer

Contract manufacturers that manufacture, repack, relabel, or salvage drugs for other companies must register with FDA independently. They must list the products they make, identifying the marketing company (private label distributor). Both the contract manufacturer and the private label distributor have regulatory responsibilities, though registration is primarily the manufacturer's obligation.

Question 38

What are 503A and 503B compounding facilities?

Accepted Answer

503A facilities are traditional compounding pharmacies that prepare customized medications for individual patients under state pharmacy licenses. 503B facilities are outsourcing facilities that compound without individual prescriptions and distribute to healthcare facilities. 503B facilities must register with FDA, comply with cGMP, and report adverse events. 503A facilities have different, state-based requirements.

Question 39

How does drug registration differ for foreign manufacturers?

Accepted Answer

Foreign drug establishments have the same registration, listing, and fee requirements as domestic establishments. Additionally, foreign establishments must designate a US Agent who resides or maintains a business in the US. Foreign facilities are subject to FDA inspection, and fees fund FDA's foreign inspection program. Import detention can occur if registration lapses.

Question 40

How are medical devices classified?

Accepted Answer

FDA classifies medical devices into three classes based on risk: Class I (low risk) - general controls only, most are 510(k) exempt; Class II (moderate risk) - general and special controls, typically requires 510(k); Class III (high risk) - requires Premarket Approval (PMA). Use FDA's Product Classification Database to find your device's classification by product code or device name.

Question 41

What is a 510(k) premarket notification?

Accepted Answer

A 510(k) is a premarket submission demonstrating your device is substantially equivalent to a legally marketed predicate device. It's required for most Class II devices and some Class I devices. The submission includes device description, predicate comparison, performance testing, and labeling. FDA review typically takes 90-180 days. Clearance allows marketing; it's not an 'approval.'

Question 42

What is a predicate device?

Accepted Answer

A predicate device is a legally marketed device to which you compare your new device in a 510(k) submission. The predicate must have the same intended use and either the same technological characteristics or different characteristics that don't raise new safety/effectiveness questions. Finding an appropriate predicate is crucial for 510(k) strategy. Multiple predicates can sometimes be used.

Question 43

What is device establishment registration?

Accepted Answer

All establishments involved in producing or distributing medical devices must register with FDA annually. This includes manufacturers, specification developers, repackagers, relabelers, initial distributors of imported devices, and contract manufacturers. Registration is done through FDA's Unified Registration and Listing System (FURLS) during October 1 - December 31. Fees apply.

Question 44

What are device registration fees?

Accepted Answer

FDA charges an annual device establishment registration fee. For FY2026, the fee is $11,423 for both domestic and foreign establishments. Small businesses may qualify for reduced fees or waivers. The fee is due at registration and annually thereafter. 510(k) submissions have separate review fees (approximately $26,067 standard, $6,517 for small business).

Question 45

What is device listing?

Accepted Answer

Device listing identifies each device you commercially distribute with FDA. All devices must be listed using the FURLS system, providing: proprietary name, establishment registration number, FDA product code, and whether 510(k) exempt. Listings must be updated annually and within 30 days of any changes. Initial listing should be done before commercial distribution.

Question 46

What is the Quality System Regulation (QSR)?

Accepted Answer

The QSR (21 CFR Part 820) establishes cGMP requirements for medical device manufacturing. It covers: management responsibility, design controls, document controls, purchasing, production controls, CAPA, labeling, and complaint handling. All finished device manufacturers must comply regardless of device class, though the complexity of implementation scales with device risk.

Question 47

What are UDI requirements?

Accepted Answer

The Unique Device Identification (UDI) system requires most devices to bear a unique identifier on labels and packages. UDI has two parts: Device Identifier (DI) for product identification and Production Identifier (PI) for lot/serial/date information. Device information must also be submitted to FDA's GUDID database. Compliance deadlines were staggered by device class (Class III first).

Question 48

What is an MDR (Medical Device Report)?

Accepted Answer

MDR is FDA's mandatory reporting system for device-related adverse events. Manufacturers must report deaths and serious injuries within 30 days (5 days for emergencies) and malfunctions that could cause death/serious injury. Importers report deaths and serious injuries. User facilities report deaths to FDA and manufacturers. Failure to report can result in significant penalties.

Question 49

What is a De Novo classification request?

Accepted Answer

De Novo is a pathway for novel low-to-moderate risk devices that lack a predicate. If your device is automatically Class III due to no predicate but you believe it's low/moderate risk, De Novo allows you to request Class I or II classification. Successful De Novo creates a new device type that can serve as a predicate for future 510(k)s.

Question 50

Do software and apps require FDA clearance?

Accepted Answer

It depends on the software's intended use. Software as a Medical Device (SaMD) that diagnoses, treats, or prevents disease may require 510(k) clearance or PMA approval depending on risk. However, FDA exercises enforcement discretion over many health and wellness apps. Clinical Decision Support software may be exempt. Use FDA's guidance documents to determine your software's regulatory status.

Frequently Asked Questions

What is FDA and what does it regulate?

Do I need FDA approval to sell products in the US?

What is FDA facility registration?

What is the difference between registration and listing?

How often must I renew my FDA registration?

What happens if I don't register with FDA?

What is a DUNS number and why do I need it?

What is cGMP and does it apply to my products?

How do I know which FDA requirements apply to my product?

What is an FDA inspection and how do I prepare?

What is Form FDA 483?

What is an FDA Warning Letter?

Can FDA recall my products?

How do I report adverse events to FDA?

What resources does FDA provide for compliance help?

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Frequently Asked Questions

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What is FDA and what does it regulate?

Do I need FDA approval to sell products in the US?

What is FDA facility registration?

What is the difference between registration and listing?

How often must I renew my FDA registration?

What happens if I don't register with FDA?

What is a DUNS number and why do I need it?

What is cGMP and does it apply to my products?

How do I know which FDA requirements apply to my product?

What is an FDA inspection and how do I prepare?

What is Form FDA 483?

What is an FDA Warning Letter?

Can FDA recall my products?

How do I report adverse events to FDA?

What resources does FDA provide for compliance help?

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