FDA Draft Unique Identifier Guidance

FDA issued a draft guidance entitled “Unique Device Identification System:Form and Content of the Unique Device Identifier (UDI)” on July 25, 2016. When finalized, this draft document will clarify for industry, FDA-accredited issuing agencies, and FDA staff the requirements under 21 CFR 801.40. “Specifically, this draft guidance defines the expected content and forms of the Unique Device Identifier (UDI), to assist both labelers, as defined under 21 CFR 801.3, and FDA-accredited issuing agencies, as defined under 21 CFR 830.3, to better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with the Unique Device Identification System Rule, 78 FR 58786 (September 24,
2013) (UDI Rule).” The full guidance is at the link provided.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.