FDA Recruits Apple and FitBit to Join its Health Technology Program
The Food and Drug Administration (FDA) has selected nine companies to join its voluntary Pre-Cert pilot program, which has been designed to foster innovation through the creation of a less restrictive regulatory framework that will lead to faster acceptance of health-related software and, in some cases, products.
Bloomberg reports, the companies that have been accepted include Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorous, Roche, Samsung, Tidepool and Verily.
In a statement, FDA Commissioner, Scott Gottlieb, commented, “We need to modernise our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate.”
Apple is studying whether its watch can detect heart abnormalities. The process it will go through to make sure it’s using sound quality metrics and other measures won’t be as costly and time-consuming as when the government clears a new pacemaker, for example. Verily is working with Novartis AG to develop a contact lens that could continuously monitor the body’s blood sugar.
When Gottlieb announced that digital health manufacturers could apply for the pilot program back in July, he said, “Historically, health care has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life.” At the time he called it, “a new and pragmatic approach to digital health technology.”
Under the pilot, the FDA will scrutinise digital health companies’ software and will inspect their facilities to ensure they meet quality standards and can adequately track their products once they’re on market. If they pass the agency’s audits, the companies would be pre-certified and may face a less stringent approval process or not have to go through FDA approval at all.
According to the FDA, more than 100 companies expressed interest in the pilot. The agency plans to hold a public workshop on the program in January to help developers not in the pilot to understand the process and four months of initial findings.