FitBit, Apple Join FDA’s Program to Pre-Certify Select Health Tech Companies

In an effort to allow a select group of health technology companies to avoid some regulations that have tied up developers working on health software and products, the U.S. Food and Drug Administration (FDA) has selected nine major tech companies for a pre-certification pilot program, Bloomberg is reporting. Apple and FitBit, the two leading health tech companies, are both part of the FDA’s new program.


The agency says the program 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.

“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 in a statement. Samsung, Verily Life Sciences, Johnson & Johnson and Roche Holding AG will also participate in the program.

“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 pre-certified and may 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”.

The program is said to be part of a broader move at the FDA to streamline regulation and get medical products to patients faster.

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