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

Description

Section 515(d)(6)(A) of the Federal Food, Drug, and Cosmetic Act (the Act) provides that PMA supplements are required for any change to a device subject to an approved application that affects safety or effectiveness, unless such change is a modification in a manufacturing procedure or method of manufacturing. 21 U.S.C. 360e(d)(6)(A). The Act states that changes in manufacturing procedures or method of manufacturing that affect safety or effectiveness require a 30-day notice. Where FDA finds such notice inadequate, FDA will inform the applicant that a 135-day PMA supplement or 75-day HDE supplement must be submitted. 21 CFR 814.39(f), 814.108. The purpose of this document is to provide guidance on the changes FDA believes may qualify for the 30-day notice and the changes that generally do not qualify.

Scope & Applicability

Regulatory Context

• 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 →

• 21CFR814.108§ 814.108 Supplemental applications.

  After FDA approval of an original HDE, an applicant shall submit supplements in accordance with the requirements for PMA's under § 814.39 , except that a request for a new indication for use of a HUD shall comply with requirements set forth in § 814.110 . The timeframes for review of, and FDA actionRead full regulation →

• 21CFR814.110§ 814.110 New indications for use.

  (a) An applicant seeking a new indication for use of a HUD approved under this subpart H shall obtain a new designation of HUD status in accordance with § 814.102 and shall submit an original HDE in accordance with § 814.104 .Read full regulation →

• 21CFR820.3§ 820.3 Definitions.

  The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see § 820.7 ) apply to this part, except as specified in paragraph (b) of this section, and do not affect the meaning of similar terms defined in this title.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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