Description
FDA regulates biological indicators (BI) intended to monitor sterilizers used in health care facilities as class II medical devices requiring premarket notification (510(k)). 21 CFR 880.2800(a).This guidancedocument provides information that will help manufacturers prepare 510(k)s for BIs used with conventional sterilization methods. FDA believes that providing this information will promote a consistent and efficient regulatory process.
Scope & Applicability
Product Classes
3Biological indicators are regulated as class II medical devices
Microbiological test system providing a defined resistance to a specified sterilization process; Guidance for premarket notification submissions of BIs; Subject of the premarket notification 510(k) submission
System that reveals change in process variables based on chemical or physical change
Stakeholders
1Prescribing professional who does not need to intervene for interchangeable substitution
Regulatory Context
Attributes
6Determined 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
Standard seven or more days for BIs
intended storage conditions throughout the proposed shelf-life
Time required to destroy 90 percent of the vegetative cells or spores at a given temperature
Temperature increase required to reduce D-value.
Quality parameter that must remain unchanged for the policy
Related CFR Sections (3)
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR862.2050§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
(a) Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.Read full regulation →
- 21CFR880.2800§ 880.2800 Sterilization process indicator.
(a) Biological sterilization process indicator —Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-08-12
CGMP/QSR/Medical Devices/Adulterated
Spectra Therapy, LLC
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated
Mectronic Medicale S.R.L.
- 2025-06-24
CGMP/QSR/Medical Devices/Adulterated
Aju Pharm Co., Ltd.
- 2025-05-27
CGMP/QSR/Medical Devices/Adulterated
Sedecal S.A.
- 2025-05-20
CGMP/QSR/Medical Devices/Adulterated
NeuroSync, Inc.
- 2025-04-22
Noah Medical Corporation
- 2025-04-08
CGMP/QSR/Medical Devices/Adulterated
EpiCare Acquisitions, LLC
- 2025-03-25
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Exer Labs, Inc.
See Also (8)
- Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) (Status: Final)
- Kit Certification for 510(k)s (Status: Final)
- Immunotoxicity Testing Guidance (Status: Final)
- Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests (Status: Final)