Description
Medical device premarket applications submitted under section 515(c)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 360(e)(c)(1)(C)], are required to include a number of information components, as set forth in 21 Code of Federal Regulations (CFR) Sec. 814.20. One component covers the current good manufacturing practice requirements included in the Quality System (QS) regulation. A Premarket Approval Application (PMA) is required to include a complete description of the methods, facilities, and controls, in sufficient detail so that FDA can make a knowledgeable assessment of the quality control used in producing the medical device (21 U.S.C. 515(c)(1)(C)).
Scope & Applicability
Stakeholders
5Entity responsible for submitting NDINs
Authorized for release by signature
Facility supplying raw materials or ingredients; Facility providing raw materials to a manufacturer
External entity responsible for manufacturing activities
participates in all formal design reviews
Regulatory Context
Attributes
3Evidence of a new intended use based on communications
considered a design input
considered a design input
Identified Hazards
Hazards
1Microorganisms or particulate matter that could adversely affect the device.
Related CFR Sections (2)
- 21CFR814.20§ 814.20 Application.
(a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →
- 21CFR814.37§ 814.37 PMA amendments and resubmitted PMAs.
(a) An applicant may amend a pending PMA or PMA supplement to revise existing information or provide additional information.Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-30
Medical Device Reporting/Misbranded
Insung Medical Co. Ltd.
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
See Also (8)
- Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Suggested Format For IDE Progress Report (Status: Final)
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 300.500 *Reprocessing of Single Use* Devices (Status: Final)
- Medical Device Reporting for User Facilities (Status: Final)
- Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff (Status: Final)
- Sterilized Convenience Kits for Clinical and Surgical Use: Final Guidance for Industry (Status: Final)
- Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers (Status: Final)