Shelf Life of Medical Devices | Guideline Explorer

Scope & Applicability

Product Classes

8

Medical Device

FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices

Class III Device

Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.

Surgeon's Gloves

Referenced under 1000 ML WATER METHOD and 335.700; Medical gloves regulated for defects and HIV protection.; Quality and defect criteria

Medical Gloves

FDA classifies these devices as accessories to medical gloves.; The primary subject of the guidance manual.

In Vitro Diagnostic Devices

Validation of certain in vitro diagnostic devices (IVDs) for emerging pathogens; Validation of certain IVD devices for emerging pathogens

Intraocular Lenses

Permanent implants placed in the eye

Class III Soft (Hydrophilic) Contact Lens Solutions

Testing guidelines for hydrophilic contact lens solutions.

Class III Contact Lenses

Guidance document for determining shelf life of Class III contact lenses.

Stakeholders

3

sponsor

responsible for justifying omission of studies

Medical Device Manufacturers

Entities preparing and maintaining a QMS; entities intended to prepare and maintain a QMS

Manufacturer

Entity responsible for submitting NDINs

Regulatory Context

Attributes

8

Shelf Life

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

Preservative concentration

Monitored parameter for solution stability.

Viscosity

Physicochemical characteristic used to assure product acceptability.

pH

Intrinsic characteristic affecting the growth of L. monocytogenes; intrinsic characteristic used as a process control; parameter to monitor for control; Process control parameters such as pH; Used to define listeristatic formulations

sterility assurance level

If the sterility assurance level (SAL) is lowered, manufacturers should consider whether device safety or effectiveness may be compromised.

Expiration Date

Property of a device that may be changed via established protocols

Stability

A functional role of sodium in food

Biocompatibility

impact the biocompatibility of the device

Identified Hazards

Hazards

4

Degradation

relevant known risk factor

Microbiological contamination

Potential for contamination of covered produce; Known or reasonably foreseeable hazards in water

Radioactive Decay

radioactive material with a relatively short half-life

Microbial Load

Considered when products cannot be well-characterized.

Related CFR Sections (5)

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 →
21CFR814.20§ 814.20 Application.
(a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead 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 →
21CFR820.5§ 820.5 [Reserved]

Related Warning Letters (10)

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