Framework
FDA21 CFR Part 814 — Premarket Approval of Medical Devices
21 CFR Part 814 establishes the requirements for premarket approval (PMA) of Class III medical devices. It describes the process by which manufacturers must demonstrate reasonable assurance of safety and effectiveness before a high-risk device can be legally marketed in the United States, including application content, review procedures, and post-approval requirements.
Overview
Background
Part 814 is maintained by the FDA and derives from the Medical Device Amendments of 1976. It provides the most rigorous premarket review pathway for medical devices, reserved for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of health, or present a potentially unreasonable risk of illness or injury.
Applicability
This regulation applies to manufacturers and applicants seeking to market Class III medical devices in the United States. It covers the PMA application process, including original PMAs, PMA supplements for device modifications, and humanitarian device exemptions (HDEs). It also defines post-approval requirements such as periodic reporting and manufacturing changes.