Description
Thisguidance documenthas been developed to provide the underlying principles and examples to establish a clear and consistent way to approach the decision-making process you follow to determine the type of regulatory submission, if any, that may be required when you modify your lawfully marketed PMA device.
Scope & Applicability
Product Classes
10Devices affected by ethylene oxide sterilization facility changes
For devices subject to PMA requirements, submission of periodic reports is required.
PMA applicant modified the system by adding a feature to visualize catheter navigation
treatment of infra-renal abdominal aortic or aorto-iliac vessels
use as an adjunct to primary lumbar spinal fusion surgery
indicated to relieve symptoms associated with benign prostatic hyperplasia
FDA approved a PMA for a hydrophilic contact lens
FDA approved a PMA for an excimer laser system indicated for wavefront-guided LASIK
FDA approved a PMA for a prosthetic heart valve for use in the aortic position
FDA approved a PMA for an HIV diagnostic (whole blood specimens)
Stakeholders
1Entity modifying the device or indication
Regulatory Context
Attributes
5Determined based on stability data; Established through stability testing; also called dating period.; Established through formal stability studies; Establishing the period during which a drug product is expected to remain within specifications; Period for drug products; The period during which a drug product is expected to remain within specifications; Duration product remains within acceptance criteria; Period during which product remains within specifications; Established for intermediates pu
Added to manufacturing instructions for boot adhesive
Information that should appear on the label or accompany the ACTP.
Defined as a new clinical data set providing valid scientific evidence
Property of a device that may be changed via established protocols
Identified Hazards
Hazards
1Where the lead comes in contact with endocardial tissue
Related CFR Sections (5)
- 21CFR814.39§ 814.39 PMA supplements.
(a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of thRead full regulation →
- 21CFR814.84§ 814.84 Reports.
(a) The holder of an approved PMA shall comply with the requirements of part 803 and with any other requirements applicable to the device by other regulations in this subchapter or by order approving the device.Read full regulation →
- 21CFR814.82§ 814.82 Postapproval requirements.
(a) FDA may impose postapproval requirements in a PMA approval order or by regulation at the time of approval of the PMA or by regulation subsequent to approval. Postapproval requirements may include as a condition to approval of the device:Read full regulation →
- 21CFR814.40§ 814.40 Time frames for reviewing a PMA.
Within 180 days after receipt of an application that is accepted for filing and to which the applicant does not submit a major amendment, FDA will review the PMA and, after receiving the report and recommendation of the appropriate FDA advisory committee, send the applicant an approval order under §Read full regulation →
- 21CFR814.44§ 814.44 Procedures for review of a PMA.
(a) FDA will begin substantive review of a PMA after the PMA is accepted for filing under § 814.42 . FDA may refer the PMA to a panel on its own initiative, and will do so upon request of an applicant, unless FDA determines that the application substantially duplicates information previously revieweRead 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
- 2025-09-23
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.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
See Also (8)
- Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff (Status: Final)
- Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Premarket Approval Application and Humanitarian Device Exemption Modular Review: Guidance for Industry and FDA Staff (Status: Final)
- CPG Sec. 300.100 Inspection of Manufacturers of Device Components (Status: Final)