Description
This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP's.
Scope & Applicability
Stakeholders
4Entity responsible for submitting NDINs
Authorized for release by signature
External entity responsible for manufacturing activities
must participate in formal design reviews
Regulatory Context
Attributes
1considered a design input
Identified Hazards
Hazards
2Risk mitigated by special controls
Microorganisms 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
- 2025-10-07
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.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
- 2025-08-26
CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
Uscom Kft
- 2025-08-19
CGMP/QSR/Medical Devices/Adulterated
Les Encres LLC
See Also (8)
- Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- 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)
- Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff (Status: Final)