FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff

Description

The Medical Device User Fee Amendments of 2022 (MDUFA V) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2022, including premarket approval applications (PMAs). The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the device review process to meet certain performance goals and implement improvements for the medical device review process.

Scope & Applicability

Regulatory Context

• 21CFR814.45§ 814.45 Denial of approval of a PMA.

  (a) FDA may issue an order denying approval of a PMA if the applicant fails to follow the requirements of this part or if, upon the basis of the information submitted in the PMA or any other information before the agency, FDA determines that any of the grounds for denying approval of a PMA specifiedRead full regulation →

• 21CFR860.7§ 860.7 Determination of safety and effectiveness.

  (a) The classification panels, in reviewing evidence concerning the safety and effectiveness of a device and in preparing advice to the Commissioner, and the Commissioner, in making determinations concerning the safety and effectiveness of a device, will apply the rules in this section.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 →

• 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 →

• CGMP/QSR/Medical Devices/Adulterated

  Envoy Medical Inc.

  2025-12-09

• CGMP/QSR/Medical Devices/Adulterated

  Hong Qiangxing Shenzhen Electronics Limited

  2025-11-25

• 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.

  2025-10-28

• CGMP/QSR/Medical Devices/Adulterated

  LEVO AG

  2025-10-21

• CGMP/QSR/Medical Devices/Adulterated

  Technological Medical Advancements LLC

  2025-10-07

• Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)

  The Richline Group, Inc.

  2025-09-23

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

  SeniorLife Technologies, Inc.

  2025-09-16

• CGMP/QSR/Medical Devices/Adulterated

  Miach Orthopaedics

  2025-08-26

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