The FDA has issued the names of the companies selected for the first wave of the pilot program. The nine participants include medical device and health technology innovators. The scheme is called the FDA’s digital health software precertification pilot program. This is part of the agency’s Digital Health Innovation Action Plan, which, in turn, derives from federal legislation passed in 2016 (21st Century Cures).
The announcements were made by U.S. FDA Commissioner Dr. Scott Gottlieb at the AdvaMed MedTech Conference, which took place in San Jose, California in January 2018. Then program, according to Gottlieb, is focused on evaluating the robustness of each company rather than the products they produce.
The companies, drawn from over 100 applicants, in the first tranche are:
Apple, Cupertino, California,
Fitbit, San Francisco, California,
Johnson & Johnson, New Brunswick, New Jersey,
Pear Therapeutics, Boston, Massachusetts,
Phosphorus, New York, New York,
Roche, Basel, Switzerland,
Samsung, Seoul, South Korea,
Tidepool, Palo Alto, California,
Verily, Mountain View, California.
As part of the scheme, each company agreed to be available for site visits from FDA staff, and to submit documented evidence concerning their quality management system.
The objective of this is to certify the company for future medical technology developments. Certification will be based on an evaluation by FDA assessors of software design, validation of the software, and maintenance levels. This will determine if each company meets pre-determined quality standards.
From this the FDA will also establish critical quality attributes and critical performance indicators for the evaluation of other companies seeking to launch products into the U.S. healthcare market.
Quoted by Bioscience Technology, Dr. Gottlieb said: “Our method for regulating digital health products must recognize the unique and iterative characteristics of these products.”
With a view to the future of healthcare, he added: We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices.”
