What does the FDA actually approve?

Medicines, biological products, high-risk medical devices, and certain other products including tobacco products requiring marketing authorisation. It does not approve most foods, cosmetics, or dietary supplements before sale, though it regulates their safety and labelling.

What is the difference between FDA approval and FDA clearance?

Approval generally refers to premarket approval of high-risk devices or to authorisation of medicines following review of efficacy and safety evidence. Clearance generally refers to a 510(k) determination that a device is substantially equivalent to a legally marketed predicate. The evidentiary standards differ substantially.

Does FDA approval apply outside the United States?

No. Each country or region has its own regulator and its own authorisation process. Some authorities with limited capacity may rely on or reference FDA decisions, but approval does not automatically transfer.

Is the FDA funded by the pharmaceutical industry?

Partly. It receives congressional appropriations alongside user fees paid by industry under periodically reauthorised legislation, which fund a substantial share of medicines and device review activity. Whether this affects independence is a longstanding and unresolved policy debate.

FDA Explained: What the U.S. FDA Does

What the FDA does: regulating medicines, biologics, medical devices, food and tobacco, how review and inspection work, its centres, powers and known criticisms.

The U.S. Food and Drug Administration is the federal agency responsible for protecting public health by regulating the safety and effectiveness of medicines, biological products, medical devices, and radiation-emitting products, and the safety of most of the food supply, cosmetics, and tobacco products. It sits within the Department of Health and Human Services.

Its scope is unusually broad by international standards. In most countries, food safety, medicines, devices, and tobacco are regulated by separate agencies; in the United States these responsibilities are largely consolidated in one body, which is one reason the FDA's decisions attract attention well beyond American borders.

What the FDA Regulates

Human medicines — prescription and over-the-counter drugs, including generics.
Biological products — vaccines, blood and blood components, cell and gene therapies, and allergenics.
Medical devices — from bandages to implantable defibrillators, including in vitro diagnostics and software intended for a medical purpose.
Radiation-emitting products — including imaging equipment and certain consumer electronics.
Food — most of the food supply, with meat, poultry, and certain egg products regulated instead by the Department of Agriculture.
Cosmetics — with authorities historically narrower than for other categories.
Tobacco products — including marketing authorisation requirements and restrictions on marketing.
Veterinary medicines and animal feed.

How the FDA Is Organised

Work is distributed across product centres:

Center for Drug Evaluation and Research — human medicines, including most therapeutic biologics.
Center for Biologics Evaluation and Research — vaccines, blood products, and cell and gene therapies.
Center for Devices and Radiological Health — medical devices, diagnostics, and radiation-emitting products.
Center for Food Safety and Applied Nutrition — food safety, labelling, and dietary supplements.
Center for Tobacco Products — tobacco regulation.
Center for Veterinary Medicine — animal drugs and feed.
Office of Regulatory Affairs — inspections, import oversight, and enforcement operations.
National Center for Toxicological Research — supporting scientific research.

How Medicines Are Reviewed

Before human testing, a sponsor submits an Investigational New Drug application containing preclinical data, manufacturing information, and the proposed clinical protocol. Studies may begin if the FDA does not object within the review period.

After clinical development, the sponsor submits a New Drug Application for a small-molecule medicine or a Biologics License Application for a biologic. Multidisciplinary review teams — clinicians, statisticians, pharmacologists, chemists, and manufacturing specialists — assess the submission, frequently reanalysing underlying datasets rather than relying on the sponsor's analyses. The agency may convene an advisory committee of external experts whose public discussion and vote inform but do not bind the decision, and may inspect clinical trial sites and manufacturing facilities.

Outcomes include approval, approval with conditions such as post-marketing study requirements or a risk evaluation and mitigation strategy, or a complete response letter identifying deficiencies. Approval may be for a narrower indication than the applicant sought.

Expedited Programmes

Several mechanisms exist for products addressing serious conditions with unmet need:

Fast track — increased interaction with the agency and eligibility for rolling review.
Breakthrough therapy — intensive guidance where preliminary evidence suggests substantial improvement over available therapy.
Priority review — a shorter review timeline.
Accelerated approval — approval based on a surrogate endpoint reasonably likely to predict clinical benefit, with confirmatory trials required to verify benefit and procedures available to withdraw the indication if they do not.

Generics and Biosimilars

Generic medicines are approved through abbreviated applications demonstrating bioequivalence to a reference product together with manufacturing quality, rather than repeating clinical efficacy trials. Biosimilars follow a distinct pathway demonstrating high similarity to a reference biologic through analytical, functional, pharmacokinetic, and targeted clinical comparison, with an additional designation available for products meeting interchangeability standards.

How Devices Are Regulated

Devices are assigned to Class I, II, or III according to risk. Most Class I and some Class II devices are exempt from premarket submission. Most Class II devices reach market through premarket notification — the 510(k) pathway — by demonstrating substantial equivalence to a legally marketed predicate device, which does not always require clinical data. Novel low-to-moderate risk devices without a suitable predicate may use the De Novo classification route. Class III devices generally require premarket approval supported by clinical evidence.

Software intended for a medical purpose is regulated as a device, and the agency has developed frameworks for machine-learning-enabled devices including predetermined change control plans that allow anticipated model updates within agreed limits.

Post-Market Responsibilities

Adverse event surveillance. Reporting systems collect reports from clinicians, patients, and manufacturers, feeding signal detection that can prompt label changes or restrictions.
Post-marketing requirements and commitments. Studies required or agreed as a condition of approval, tracked publicly.
Inspections. Manufacturing facilities, domestic and foreign, are inspected for compliance with good manufacturing practice.
Recalls. Usually initiated by manufacturers under FDA oversight, classified by the seriousness of the hazard.
Enforcement. Warning letters, import alerts, seizure, injunction, and referral for prosecution.
Advertising and promotion. Oversight of prescription drug promotion, including action against misleading claims and off-label promotion.
Supply and shortages. Monitoring and mitigation of drug and device shortages.

Emergency Powers

Under specified statutory conditions, the FDA can issue emergency use authorisations permitting use of unapproved products, or unapproved uses of approved products, during a declared emergency when no adequate alternative exists and the known and potential benefits outweigh the known and potential risks. Such authorisations are not approvals; they are temporary, reviewed as evidence accumulates, and can be revised or revoked.

Funding and Independence

The FDA is funded through congressional appropriations and, substantially for medicines and devices, through user fees paid by industry under legislation periodically reauthorised. User fees were introduced to fund additional reviewer capacity and shorten review times, and review timelines did shorten following their introduction.

The arrangement is also the agency's most persistent source of criticism, on the argument that dependence on industry payments creates pressure towards approval or towards speed. The agency's position is that fees fund capacity while review standards and decisions remain independent, and that user fee legislation sets performance goals rather than outcomes. This is a genuine and continuing policy debate rather than a settled question, and it recurs at each reauthorisation.

Criticisms and Debates

The 510(k) pathway. Criticised on the grounds that long chains of predicate devices can distance a currently marketed device from any original clinical evidence, and that devices whose predicates were recalled may still serve as reference points.
Accelerated approval. Concerns centre on delayed or unfulfilled confirmatory trials and on the difficulty of withdrawing indications once products are in use, prompting legislative and procedural reforms.
Advisory committee influence. Debate over the weight given to committee recommendations and over management of member conflicts of interest.
Speed versus certainty. Patient groups often press for faster access while others emphasise the risk of approving treatments whose benefit is later not confirmed.
Scope limits. Dietary supplements and, historically, cosmetics have been subject to weaker premarket authority than medicines.

How the FDA Compares Internationally

The FDA both assesses and decides. In the European Union, the European Medicines Agency's committees issue a scientific opinion and the European Commission takes the binding decision. The FDA conducts review largely with in-house staff; the EMA coordinates a network drawing on national agency expertise. Both apply a benefit-risk standard and often reach similar conclusions, though differences in timing, indication wording, and population restrictions are common.

FDA decisions carry influence beyond the United States: some national regulators with limited capacity rely on or reference decisions by well-resourced authorities, and FDA assessments feed into international harmonisation work through bodies such as the International Council for Harmonisation.

Sources

U.S. Food and Drug Administration — organisational structure; drug and device approval processes; expedited programmes; emergency use authorisation; recalls and enforcement
U.S. Department of Health and Human Services — agency oversight
Federal Food, Drug, and Cosmetic Act and subsequent amending legislation
U.S. Government Accountability Office — reports on FDA programmes and oversight
International Council for Harmonisation — technical requirements for pharmaceuticals