
Bloomberg
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 US food supply, said that it had selected nine major tech companies for a pilot programme that may let them avoid some regulations that have tied up developers working on health software and products.
“We need to modernise our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,†FDA Commissioner Scott Gottlieb said in a statement.
The programme is meant to let the companies get products pre-cleared 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 programme is meant to help the companies more rapidly develop new products while maintaining some government oversight of technology that may 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.
Faster Pace
“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 programme.
Officially dubbed the Pre-Cert for Software Pilot, Gottlieb at the time called it “a new and pragmatic approach to digital health technology.â€
The other companies included in the pilot are Pear Therapeutics Inc., Phosphorus Inc. and Tidepool. More than 100 companies were interested in the pilot, according to the FDA. The agency plans to hold a public workshop on the programme in January.