CPG Sec. 280.100 - Stability Requirements - Licensed In Vitro Diagnostic Products

Description

The purpose of this Compliance Policy Guide (CPG) is to provide guidance to FDA staff on stability studies for in vitro diagnostic products (IVDs) licensed by the Center for Biologics Evaluation and Research (CBER).  In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. The use of the word “should” in FDA’s guidances means that something is suggested or recommended but not required.

Scope & Applicability

Regulatory Context

• 21CFR601.12§ 601.12 Changes to an approved application.

  (a) General.Read full regulation →

• 21CFR809.10§ 809.10 Labeling for in vitro diagnostic products.

  (a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise specified in a standard for a particular product class or as provided in paragraph (e) of this section. Section 201(k) of the act provides that “a Read full regulation →

• 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.

  (a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead full regulation →

• 21CFR10.115§ 10.115 Good guidance practices.

  (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.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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