Update on Software Precertification Pilot Program: FDA seeks public input

Update on Software Precertification Pilot Program: FDA seeks public input

Today the FDA made new information about the Software Precertification (Pre-Cert) Pilot Program available and seeks public input on the updated version of its Pre-Cert Program working model. This version of the working model is the FDA’s current, proposed framework and vision. It outlines the Pre-Cert Program’s key components:Excellence Appraisal and Determining Precertification Level, Review Pathway Determination, Streamlined Premarket Review Process, and Monitoring Real-world Performance.

Stakeholders’ input on the Software Precertification Pilot Program working model will help inform the launch of the first version of the Software Precertification Program, PreCert1.0, by the end of 2018. The FDA continues to evaluate input we have received on the first version of the working model and future iterations of the working model will incorporate this input, as appropriate.

What’s New about the Working Model: 

·         Includes release notes detailing changes made from the previous version of the model, describes how the proposed program components intersect, and highlights areas where the FDA has incorporated input from comments received in the public docket through May 2018 and where the agency is seeking more input. The public can also provide input on the Challenge Questions available on the Pre-Cert webpage.

·         Proposes revised levels of Pre-Cert for companies, new proposed elements for a company to demonstrate their excellence, and updated description of the framework for the appraisal process.

·         Provides further details on how the FDA might leverage the IMDRF’s risk categorization framework to enable precertified companies to determine the premarket review pathway for their products.

·         Clarifies proposed expectations for precertified companies and possible approaches for putting products through an FDA-streamlined review process.

·         Proposes the types of real-world analytics that precertified companies would be expected to monitor after the product is on the market.

More information about how this version of the working model is different from the working model we released in April is available in the Working Model 0.2 document. 

In the Pre-Cert program, the FDA is proposing that software products from precertified companies would continue to meet the same safety and effectiveness standard that the agency expects for products that have followed the traditional path to market. Precertification would enable more efficient and streamlined oversight of medical device software products without compromising their safety and effectiveness.

In Case You Missed It: 

The webcast recording is available for the user session that took place on Thursday, May 10, 2018.  Future sessions will be announced on the Software Precertification Pilot Program webpage and through CDRHNew.

These efforts are part of the FDA’s goal to encourage digital health innovation by making the agency’s policies and processes more efficient and modernizing our regulatory tools. 

Please send any questions about the program to fdapre-certpilot@fda.hhs.gov.

Thank you,

Food and Drug Administration