Tech firms join pilot aimed at faster FDA OK
A federal agency that regulates apples wants to make regulations on Apple Inc. a little easier.
The Food and Drug Administration, which oversees new drugs, medical devices and much of the U.S. food supply, said last week that it had selected nine major tech companies for a pilot program that could let them avoid some regulations that have tied up developers working on health software and products.
“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” FDA Commissioner Scott Gottlieb said.
The program is meant to let the companies get products precleared rather than going through the agency’s standard application and approval process that can take months. Along with Apple, FitBit Inc., Samsung Electronics Co., Verily Life Sciences, Johnson & Johnson and Roche Holding AG will participate.
The FDA program is meant to help the companies more rapidly develop new products while maintaining some government oversight of technology that could be used by patients or their doctors to prevent, diagnose and treat conditions.
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, the life sciences arm of Google parent Alphabet Inc., is working with Novartis AG to develop a contact lens that could continuously monitor the body’s blood sugar.
“Historically, health care has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life,” Gottlieb said in July when he announced that digital health manufacturers could apply for the pilot program.
Officially dubbed the PreCert for Software Pilot, Gottlieb at the time called it “a new and pragmatic approach to digital health technology.”
The program is part of a broader move at the FDA, particularly since Gottlieb took over in May, to streamline regulation and get medical products to patients faster. The commissioner said recently the agency will clarify how drugmakers might use data from treatments already approved for some diseases to gain approvals for more conditions. In July, he delayed oversight of electronic cigarettes while the agency decides what information it will need from makers of the products.
As Silicon Valley developers have pushed into health care, the industry has been at times uncertain about when it needed the FDA’s approval. In 2013, the consumer genetesting company 23andMe Inc. was ordered by the agency to temporarily stop selling its health analysis product until it was cleared by regulators, for example.
Under the pilot, the FDA will scrutinize 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 the market. If they pass the agency’s audits, the companies would be precertified and could face a less stringent approval process or not have to go through FDA approval at all.
More than 100 companies were interested in the pilot, according to the FDA. The agency plans to hold a public workshop on the program in January to help developers not in the pilot understand the process and four months of initial findings.