A federal agency that regulates apples wants to make regulationson 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 Tuesday thatit had selected nine major tech companies for a pilot program thatmay let them avoid some regulations that have tied up developersworking on health software and products.

“We need to modernize our regulatory framework so that itmatches the kind of innovation we’re being asked to evaluate,” FDACommissioner Scott Gottlieb said in a statement.

The program is meant to let the companies get productspre-cleared rather than going through the agency’s standardapplication and approval process that can take months. Along withApple, Fitbit Inc., Samsung Electronics Co., Verily LifeSciences, Johnson & Johnson and Roche Holding AG willparticipate.

The FDA program is meant to help the companies more rapidly develop new products whilemaintaining some government oversight of technology that may beused by patients or their doctors to prevent, diagnose and treatconditions.

Apple is studying whether itswatch can detect heart abnormalities. The process it willgo through to make sure it’s using sound quality metrics and othermeasures won’t be as costly and time-consuming as when thegovernment clears a new pacemaker, for example. Verily, the lifesciences arm of Google parent Alphabet Inc., is workingwith Novartis AG to develop a contact lens thatcould continuously monitor the body’s blood sugar.

Faster Pace

“Historically, health care has been slow to implement disruptive technology tools that havetransformed other areas of commerce and daily life,”Gottlieb said in July whenhe announced that digital health manufacturers could apply for thepilot program.

Officially dubbed the Pre-Cert for Software Pilot, Gottlieb atthe time called it “a new and pragmatic approach to digital healthtechnology.”

The other companies included in the pilot are Pear TherapeuticsInc., Phosphorus Inc. and Tidepool.

The program is part of a broader move at the FDA, particularlysince Gottlieb took over in May, to streamline regulation and getmedical products to patients faster. Thecommissioner said last week theagency will clarify how drugmakers might use data from treatmentsalready approved in some disease to gain approvals for moreconditions. In July, he delayed oversight of electroniccigarettes while the agency decides what information it willneed from makers of the products.

Rules Uncertainy

As Silicon Valley developers have pushed into health care, theindustry has been at times uncertain about when it needed the FDA’sapproval. In 2013, the consumer gene-testing company 23andMe Inc.was ordered by the agency to temporarily stopselling its health analysis product until it was cleared byregulators, for example.

Under the pilot, the FDA will scrutinize digital healthcompanies’ software and will inspect their facilities to ensurethey meet quality standards and can adequately track their productsonce they’re on the market. If they pass the agency’s audits, thecompanies would be pre-certified and may face a less stringentapproval process or not have to go through FDA approval at all.

More than 100 companies were interested in the pilot, accordingto the FDA. The agency plans to hold a public workshop on theprogram in January to help developers not in the pilot understandthe process and four months of initial findings.

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