On July 27, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, announced a pilot program that would allow medical software startups to become “pre-certified” for fast-track approval.
The pilot program, part of the FDA’s broader Medical Innovation Access Plan, is intended to accelerate the approval process for medical software and products deemed less risky than traditional medical devices. The pre-certification process will focus on the company, rather than the product, to ensure that necessary quality standards are met. Pre-certified status would allow a company to provide less information before premarket submission of a device or product.
Companies will be selected for the program based on the following qualifications:
- The company must be developing or planning to develop a software product that meets the definition of a medical device.
- The company must have an existing track record in developing, testing, and maintaining software products and demonstrating a culture of quality and organizational excellence that is tracked by Key Performance Indicators (KPIs) or other similar measures.
- During participation in the pilot, the company must agree to:
- provide access to measures for developing, testing, and maintaining software products and demonstrating a culture of quality and organizational excellence measures by KPIs;
- collect real-world post-market data and provide them to the FDA;
- meet with the FDA for real-time consultation;
- be available for site visits from FDA officials; and
- provide information about the firm’s quality-management system.
In his announcement, Dr. Gottlieb explained that the FDA has “intentionally left the initial criteria broad because this pilot is purposely designed to be inclusive and flexible” in order “to accommodate a broad range of participants and technologies.”
Sources: FDA Voice blog, July 27, 2017; CNBC, July 27, 2017.