United States (FDA)
21 CFR Part 814: Premarket Approval
Part 814 governs premarket approval, the most demanding US marketing pathway, used for most class III devices. A PMA asks FDA to conclude there is reasonable assurance the device is safe and effective, and approval typically depends on a pre-approval inspection of the facilities where it will be made.
At a Glance
- Regulation
- 21 CFR Part 814
- Subject
- Premarket Approval
- Group
- United States (FDA)
- Industries
- 3 industry guides reference it
A plain-language summary, not legal advice. Always read the current official text.
What It Covers
A PMA application presents the full case for the device: a description of the device and how it is made, nonclinical laboratory studies, clinical investigation data, proposed labeling, and a description of the manufacturing methods, facilities and controls. FDA may refer the application to an advisory panel. Because manufacturing is part of the application, the QMS and the PMA are reviewed together.
Before approving a PMA, FDA generally inspects the manufacturing facilities to confirm the firm can make the device as described and that its QMS meets Part 820. Compliance Program 7382.850 lists PMA pre-approval and postmarket inspections among its inspection types. Design records, process validation and supplier controls for the PMA device are typical areas of focus.
Approval is the start of ongoing obligations. Changes that affect the safety or effectiveness of an approved device generally require a PMA supplement, and Part 814 describes different supplement types and notices depending on the nature of the change. Approved PMAs carry postapproval requirements, including periodic (annual) reports, and FDA may impose conditions of approval such as postapproval studies. Part 814 also contains the humanitarian device exemption (HDE) provisions for devices intended for small patient populations.
Who It Applies To
- Manufacturers of class III devices that require premarket approval
- PMA holders making design, labeling, manufacturing or supplier changes to approved devices
- Contract manufacturers and critical suppliers whose sites may be inspected as part of a PMA
- Sponsors of humanitarian use devices pursuing an HDE
What Auditors Check
Consistency With the Application
Whether the device, processes and facilities match what the PMA describes. Gaps between the submission and the shop floor are a core pre-approval concern.
Design Controls and Design History
Traceable design inputs, outputs, verification, validation and risk management for the PMA device.
Process Validation
Validated manufacturing and sterilization processes, with evidence that validated parameters are the ones in use.
Supplier and Contract Manufacturer Controls
Controls over suppliers of critical components and services named in the application.
Change Control and PMA Supplements
Whether changes after approval were assessed against PMA supplement requirements and submitted when required before implementation.
Postapproval Reporting
Timely annual reports and completion of any postapproval study or condition of approval.
Related Services
PMA Pre-Approval Inspection Preparation
Getting Class III manufacturers ready for the facility inspection that accompanies PMA review.
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
Mock FDA Inspection
A practice FDA inspection in our Inspection Simulator, with an advisor playing the investigator.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
Industry Guides That Reference 21 CFR Part 814
Questions
Will FDA inspect us before approving our PMA?
FDA generally conducts a pre-approval inspection of the facilities involved in manufacturing a PMA device. Investigators check that your QMS meets Part 820 and that production matches what the application describes. Preparation should start well before the application is filed.
Do all changes to a PMA device need a supplement?
Changes that affect the device's safety or effectiveness generally need a PMA supplement, and Part 814 describes different types depending on the change. Other changes may be reported in the annual report. Every change should be assessed and the conclusion documented through change control.
What is an HDE?
A humanitarian device exemption is a pathway in Part 814 for humanitarian use devices intended for small patient populations. It is subject to its own requirements and limits. Whether it fits depends on your device and its designation.
How does a mock inspection help before a pre-approval inspection?
A mock inspection lets your team practice producing records, answering questions and staying within scope before FDA arrives. In the FDA Inspection Simulator, an advisor plays the investigator, document requests run on response clocks, and practice observations convert into findings in your action plan. It is always a practice exercise, not an FDA outcome.
21 CFR Part 814
Check Your Quality System Against 21 CFR Part 814
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