Pre-Cert

On Friday, July 28, FDA announced a new Software Pre-certification (Pre-Cert) Pilot Program in a Federal Register notice.  The Pre-Cert program is one of three main action items discussed in the agency’s recently-released Digital Health Innovation Action Plan.  CDRH also held a webinar on August 1 to provide an overview of the program and answer stakeholder questions.

In an accompanying FDA Voice blog post, Commissioner Gottlieb acknowledged that “FDA’s traditional approach to medical devices is not well suited” to digital health products.  The agency is looking to develop a new regulatory framework that “accommodates the distinctive nature of digital health technology, its clinical promise, the unique user interface, and industry’s compressed commercial cycle of new product introductions.”

The Pre-Cert pilot program is the agency’s first step in developing the Pre-Cert program that the agency initially announced last month.  The Pre-Cert program will replace the agency’s current product-by-product premarket review process with a process to pre-certify software developers who demonstrate sufficient quality performance.  Pre-certified developers would be able to market their software devices with no, or streamlined, premarket review.  The program is intended to allow manufactures of software devices to get to market faster and have greater flexibility to iterate product design based on real world experience.

To move the Pre-Cert program from concept to implementation, the agency is initiating a pilot program.  The goal of the pilot is to leverage input from the participating companies to help the agency establish the appropriate criteria for pre-certification and appropriate review process for pre-certified companies.  Thus, participating companies will have a remarkable opportunity to shape the program and the agency’s regulatory approach to digital health products.

The Pre-Cert program’s developer-based approach represents a significant shift from the agency’s longstanding, fundamental approach to regulating medical products on a product or category basis regardless of the manufacturer.  We expect that there will be significant interest in the pilot, although FDA will only select nine companies to participate.  FDA also strongly encourages companies who do not participate in the pilot to submit feedback through the public docket.Continue Reading FDA Initiates Software Precertification Pilot Program