Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff

Description

FDA is issuing this draft guidance to propose a policy for Predetermined Change Control Plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for a device. A PCCP is the documentation describing what modifications will be made to a device and how the modifications will be assessed. This draft guidance recommends that a PCCP for a device describe the planned device modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications. FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP. The recommendations in this draft guidance apply to devices, including device-led combination products, reviewed through the 510(k), De Novo, and PMA pathways.

Scope & Applicability

Regulatory Context

• 21CFR814.9§ 814.9 Confidentiality of data and information in a premarket approval application (PMA) file.

  (a) A “PMA file” includes all data and information submitted with or incorporated by reference in the PMA, any IDE incorporated into the PMA, any PMA supplement, any report under § 814.82 , any master file, or any other related submission. Any record in the PMA file will be available for public discRead full regulation →

• 21CFR801.5§ 801.5 Medical devices; adequate directions for use.

  Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specificatiRead full regulation →

• 21CFR830.50§ 830.50 Changes that require use of a new device identifier.

  (a) Whenever you make a change to a device that is required to bear a unique device identifier (UDI) on its label, and the change results in a new version or model, you must assign a new device identifier to the new version or model.Read 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 →

• 21CFR807.93§ 807.93 Content and format of a 510(k) statement.

  (a)Read full regulation →

• 21CFR807.92§ 807.92 Content and format of a 510(k) summary.

  (a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →

• 21CFR807.81§ 807.81 When a premarket notification submission is required.

  (a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →

• 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 →

• 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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