Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 14-565
Standard
USP-NF  M98802_01_01
<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
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.
Relevant FDA Guidance and/or Supportive Publications*
1. USP-NF_M98800_01_01 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests.

2. USP-NF M98810_01_01 <71> Sterility Tests.

3. DOI: https://doi.org/10.31003/USPNF_M98802_01_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 Contact
 Shanil Haugen
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA/
  301-796-0301
  shanil.haugen@fda.hhs.gov
Standards Development Organization
USP-NF United States Pharmacopeia (USP) and the National Formulary (NF) http://www.uspnf.com/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
-
-