Description
For questions on the content of the guidance, contact CBER’s Office of Compliance and Biologics Quality at 301-827-3031; CDER’s Office of Pharmaceutical Science at 301-796-1228; CDRH’s Office of Device Evaluation at 240-276-3747; or CVM’s Office of New Animal Drug Evaluation at 301-827-6963.
Scope & Applicability
Product Classes
4Products covered by ICH stability guidelines
Licensed IVDs subject to stability requirements
Medical devices intended for human use; Approved or cleared medical devices
Scope of the guidance
Stakeholders
1Responsible for declaring acceptable market names on labels.
Regulatory Context
Attributes
2Should be 6 months from the date of collection.; Expiration or use-by period on container label
Determined 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
Related CFR Sections (9)
- 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 →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR514.8§ 514.8 Supplements and other changes to an approved application.
(a) Definitions.Read full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR600.3§ 600.3 Definitions.
As used in this subchapter: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 →
- 21CFR211.166§ 211.166 Stability testing.
(a) There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates. The written program shall be followed and shall include:Read full regulation →
- 21CFR610.12§ 610.12 Sterility.
(a) The test. Except as provided in paragraph (h) of this section, manufacturers of biological products must perform sterility testing of each lot of each biological product's final container material or other material, as appropriate and as approved in the biologics license application or supplemenRead full regulation →
- 21CFR211.167§ 211.167 Special testing requirements.
(a) For each batch of drug product purporting to be sterile and/or pyrogen-free, there shall be appropriate laboratory testing to determine conformance to such requirements. The test procedures shall be in writing and shall be followed.Read full regulation →
Related Warning Letters (10)
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated
Mectronic Medicale S.R.L.
- 2025-06-03
CGMP/Finished Pharmaceuticals/Adulterated
Huangshi Hygienic Material Medicine Co., Ltd.
- 2025-05-20
CGMP/Finished Pharmaceuticals/Adulterated
Wuxi Medical Instrument Factory Co., Ltd.
- 2024-11-26
CGMP/Finished Pharmaceuticals/Adulterated
Catwalk Cosmetic Laboratories Pty Ltd.
- 2024-11-19
CGMP/Finished Pharmaceuticals/Adulterated
Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd.
- 2024-09-10
CGMP/QSR/Medical Devices/Adulterated
Optikem International, Inc.
- 2024-05-07
CGMP/QSR/Medical Devices/Adulterated
Bioptimal International
- 2024-01-04
Investigational Device Exemptions (IDE)
Kimera Labs, Inc.
- 2023-11-21
CGMP/Finished Pharmaceuticals/Adulterated
AmLion Toothpaste Mfg. Sdn. Bhd.
- 2023-10-31
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
WAVi Co.
See Also (8)
- Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases: Guidance for Stakeholders and Food and Drug Administration Staff (Status: Final)
- Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear - Guidance for Industry and FDA Staff (Status: Final)
- Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA Staff (Status: Final)
- Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry (Status: Draft)
- Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Content of Human Factors Information in Medical Device Marketing Submissions: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Procedures for Handling Post-Approval Studies Imposed by PMA Order: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)