FDA Provides Pre-Certification Working Model

The partial shutdown of many federal agencies has apparently not stopped the U.S. Food and Drug Administration (FDA) from issuing new guidance on the certification of digital health devices.

In a posting to its website on January 7th, the FDA announced the availability of several documents in support of the testing phase of its Software Precertification Pilot Program, which is scheduled to begin later this year. The documents posted to the FDA website include:

  • Pre-Cert Working Model Version 1.0, which details changes made from previous versions of the model and how key program components intersect;
  • Pre-Cert 2019 Test Plan, which outlines how the agency will verify that the Working Model validates the safety and effectiveness of software products; and
  • Pre-Cert Regulatory Framework for Conducting the Pilot Program, which details the implementation of the Pilot program.

As part of the posting, the FCC also announced that it will host an online webinar on Thursday, February 7th, in which software developers will be able to get answers to their questions about the FDA’s Software Precertification Pilot Program. Read additional details about the webinar and access copies of the newly posted documents.

Leave a Reply

Your email address will not be published.