Food and Drug Administration (FDA)

Q: Which FDA center regulates medical devices?

CDRH regulates most medical devices and radiation-emitting products; some combination products involve CDER or CBER depending on the primary mode of action.

Q: What’s the difference between 510(k) and PMA?

A 510(k) demonstrates substantial equivalence to a predicate for generally Class II devices. A PMA demonstrates safety and effectiveness for high-risk Class III devices.

Q: Does FDA approval ensure reimbursement?

No. Payer coverage and payment decisions (e.g., CMS, private insurers) are separate from FDA authorization.

Q: How does FDA enforce compliance?

FDA enforces through inspections, Warning Letters, import actions, recalls/corrections, and litigation (e.g., seizures, injunctions) as necessary.

Food and Drug Administration (FDA) is a U.S. federal agency within the Department of Health and Human Services (HHS) responsible for protecting and promoting public health under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and related statutes (e.g., Public Health Service Act). FDA regulates human and veterinary drugs, biological products, medical devices, foods, cosmetics, tobacco products, and radiation-emitting electronic products, setting requirements for safety, effectiveness/performance, quality, labeling, and post-market surveillance.

HHS AgencyFD&C ActPublic Health

How FDA is organized (selected Centers/Offices)

CDRH — Center for Devices and Radiological Health (medical devices, radiation-emitting products).
CDER — Center for Drug Evaluation and Research (human drugs).
CBER — Center for Biologics Evaluation and Research (biologics, vaccines, blood).
CFSAN — Center for Food Safety and Applied Nutrition (foods, dietary supplements).
CVM — Center for Veterinary Medicine (animal drugs/foods).
CTP — Center for Tobacco Products (tobacco/nicotine products).
ORA — Office of Regulatory Affairs (inspections, import operations, compliance).

What FDA does (devices focus)

Market authorization: Device pathways include 510(k) clearance (21 CFR 807), De Novo classification (21 CFR 860), and PMA approval (21 CFR 814). Emergency use is possible via EUA authorities when applicable.
Quality systems: Enforcement of the device quality regulation (QMSR, 21 CFR 820, effective Feb 2, 2026), aligned with ISO 13485:2016 plus FDA-specific provisions.
Post-market oversight: Medical Device Reporting (21 CFR 803), corrections/removals (21 CFR 806), Unique Device Identification (21 CFR 801 subpart B), post-approval studies/522 orders when applicable.
Compliance & enforcement: inspections, Warning Letters, import alerts, recalls (21 CFR 7; device corrections/removals 21 CFR 806).

Key distinctions

Approval vs. clearance: Only PMA devices receive an “approval” order; most Class II devices are “cleared” via 510(k). De Novo results in a new Class I/II classification.
Regulatory vs. reimbursement: FDA authorization does not guarantee coverage or payment (e.g., CMS decisions are separate).
Global alignment: FDA participates in international initiatives (e.g., IMDRF, MDSAP) to improve convergence and audit efficiency.

FDA — FAQs

Which FDA center regulates medical devices?

CDRH regulates most medical devices and radiation-emitting products; some combination products are reviewed with CDER/CBER involvement depending on the primary mode of action.

What’s the difference between 510(k) and PMA?

510(k) demonstrates substantial equivalence to a predicate (generally Class II). PMA demonstrates safety and effectiveness with comprehensive evidence for high-risk Class III devices.

Does FDA require ISO 13485 certification?

No. FDA requires compliance with U.S. quality regulations. From Feb 2, 2026, QMSR incorporates ISO 13485:2016 by reference but third-party certification is not mandatory.

Does FDA approval ensure reimbursement?

No. Coverage and payment decisions are made by payers (e.g., CMS, private insurers) and are separate from FDA authorization.

How does FDA enforce compliance?

Through inspections, Warning Letters, import actions, seizures/injunctions via the Department of Justice, and oversight of recalls and field corrections.