FDA to regulate new rules on health apps and devices

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Food and Drug Administration

The US Food and Drug Administration (FDA) announced the digital health software pre certification pilot program during the AdvaMed MedTech Conference in San Jose, California, of which nine major companies will be acting as guinea pigs in the pilot stage.

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The firms will take part in a program that could make it faster for digital health devices. To come to market by requiring less information to be sent to regulators ahead of time the U.S. Food and Drug Administration said. The program was officially launched on 27 July as part of the agency’s Digital Health Innovation Action Plan. Over 100 companies applied to join the pilot program, leading to the selection of nine in total.

If the new program results in a regulatory framework speeds up the acceptance of acceptable health-related services, apps, and products. This not only benefits the businesses themselves bringing such ideas to market but consumers themselves.

Every company in the pilot has agreed to provide the FDA with access to development, testing, and maintenance protocols. Including how post-market data gathered.

Consumer technology companies have been reluctant to wade directly into territory regulated by the FDA. Apple has tended to partner with existing health researchers and companies such as DexCom Inc. A conventional medical device firm for uses of their products that involve regulatory oversight.

Evaluating companies based on their software-design systems work.

Moreover, the FDA has been moving to relax some of its requirements. The FDA in July created a pilot program that would pre-certify certain companies. So that they have to submit less information before marketing a product.

The initial participants in the pilot program also included Samsung Electronics, Alphabet’s Verily biotech unit, Johnson & Johnson and Swiss biotech firm Roche AG, among others. The FDA said in a statement it was also considering whether companies in the pilot program may not have to submit a product for premarket review in some cases.

“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” FDA Commissioner Scott Gottlieb said in the statement.

Although, one major difference in the pilot program from existing regulations. It will evaluate companies based on how well their software-design systems work. Rather than looking at each product and its accompanying software individually.

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“We are hopeful this will allow us to accelerate FDA regulated features and software development. Bringing new capabilities that could positively impact health outcomes to market more quickly,” Fitbit CEO James Park said in a statement.

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