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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Recognition 08/14/2015 
FR Recognition Number 13-78
Standard
IEC ISO 30111 First edition 2013-11-01
Information technology - Security techniques - Vulnerability handling processes
Scope/Abstract
This International Standard gives guidelines for how to process and resolve potential vulnerability information in a product or online service.

This International Standard is applicable to vendors involved in handling vulnerabilities.

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)
21CFR 820.50 Purchasing controls
21CFR 820.90 Non-conforming product
21CFR 820.30i Design changes
21CFR 820.100 C.A.P.A.
21CFR 820.198 Complaint files
21CFR 820.30e Design review.
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Brian Fitzgerald
  FDA/OMPT/CDRH/OSEL/
  301-796-2579
  brian.fitzgerald@fda.hhs.gov
Standards Development Organizations
IEC International Electrotechnical Commission http://www.iec.ch/
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Software/Informatics
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