Samsung scores partnership with US FDA's digital health software program

Eight other companies are part of the program including Apple and Fitbit.

The US Food and Drug Administration (FDA) has chosen Samsung Electronics Co as a partner in a digital health software program it developed. The South Korean tech giant has been selected from more than 100 brands who had shown interest in the program.

Samsung is one of the nine companies the FDA selected to work with on its new program in providing certification to companies that wish to launch new health-related products. Aside from Samsung, other companies in the said program are Apple, Fitbit, Pear Therapeutics, Tidepool, Verily, Phosphorus, Roche and Johnson & Johnson.

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"These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product," says Dr Scott Gottlieb, FDA commissioner, in a statement of the agency.

FDA's pilot program is aimed at revolutionising digital health regulation in the US. With the help of these companies, which the agency described to be the innovators and leaders in the medical device and technology sector, FDA's digital health software pre-certification program "will help in taking a tailored approach towards digital health technology's software rather focusing on the end product".

Part of the process is to review the software design and its validation and maintenance to determine if it meets quality standards. Once approved, pre-certification will be issued.

The pre-certification program was first launched on 27 July as part of FDA's Digital Health Innovation Action Plan.

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