AAMI News August 2018

FDA Updates Pre-Cert Program Framework, Seeks Additional Input

As part of the Food and Drug Administration’s (FDA) ongoing effort to modernize the regulation of digital health technologies, the agency released a second draft of its Digital Health Software Precertification (Pre-Cert) Program framework earlier this summer. The updated document incorporates comments the FDA received on its initial draft and was accompanied by a call for additional feedback.

The Pre-Cert program is a voluntary pathway intended to streamline the premarket review of software as a medical device (SaMD) products by certifying the companies that develop them. According to the FDA, such a program is needed because the agency’s traditional hardware-based approach to regulation is too slow for the rapid pace of software development.

“The goal of the program is to have tailored, pragmatic, and least burdensome regulatory oversight that assesses organizations (large and small) to establish trust that they have a culture of quality and organizational excellence such that they can develop high quality SaMD products,” the FDA wrote. The agency emphasized that the program would be “available for any size organization” after concerns were raised that larger, more established companies would be prioritized over startups.

Other changes highlighted in the updated working model include:

  • Revised levels of Pre-Cert status for companies, proposed elements for a company to demonstrate its excellence, and an updated description of the framework for the appraisal process.
  • Details about how the FDA might leverage the International Medical Device Regulators Forum’s risk categorization framework to enable precertified companies to determine the premarket review pathway for their products.
  • Clarification of proposed expectations for precertified companies and possible approaches for putting products through a streamlined review process.
  • Types of real-world analytics that precertified companies would be expected to monitor after the product is on the market.

The FDA is seeking continued public input via questions posted on its website and an open docket at www.regulations.gov.

“FDA intends to continue reviewing the public docket approximately every two weeks and to refine this program by incorporating, as appropriate, comments in future versions of the working model,” according to the agency. “We encourage the public to provide feedback early and often.”

The launch of the first version of the Pre-Cert program, called Pre-Cert 1.0, is expected by the end of the year.