Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

057

Date of Entry 12/20/2021

FR Recognition Number

14-566

Standard

USP-NF M98795_02_01
<55> Biological Indicators -- Resistance Performance Tests

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§880.2800	Indicator, Biological Sterilization Process	Class 2	FRC

Relevant FDA Guidance and/or Supportive Publications*

1. Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, Issued October 2007.

2. USP-NF M7414_01_01 <1229.5> Biological Indicators for Sterilization.

3. DOI: https://doi.org/10.31003/USPNF_M98795_02_01.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Aprajita Garg

FDA/OC/CDRH/OPEQ/OHTVI/DHTVIC/

240-402-7667

Aprajita.Garg@fda.hhs.gov

Poulomi Nandy

FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/

301-796-7048

Poulomi.Nandy@fda.hhs.gov

Standards Development Organization

USP-NF

United States Pharmacopeia (USP) and the National Formulary (NF)