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FDA Selects Nine Participants for Digital Health Software Pilot Program

27 September 2017

A USA federal agency that regulates apples wants to make regulations on Apple Inc a little easier.

"We applaud the FDA for taking a progressive and thoughtful approach to designing a potential new digital health regulatory framework and are proud to have been selected to participate in this innovative pilot program", James Park, cofounder and CEO of Fitbit, said in a corporate press release. It has already pre-certified nine companies, including Apple, Samsung, Alphabet's Verily, FitBit, Roche and Johnson & Johnson.

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 has hinted before at products to monitor blood glucose levels non-invasively, and its new Apple Watch has a pilot program for continuous heart rate monitoring in order to detect heart abnormalities.

Under the terms of the program, the FDA will scrutinize prospective products to ensure they're going to meet quality standards, and using robust metrics and data. In July, the regulatory body said the program is determining the best method to regulate non-traditional medical tools.

One major difference in the pilot program from existing regulations is that it will evaluate companies based on how well their software-design systems work, rather than looking at each product and its accompanying software individually. The plan outlines the agency's vision for fostering digital health innovation while continuing to protect and promote public health by providing clarity on medical software provisions of federal legislation passed in 2016 (21st Century Cures), adding expertise to the digital health unit and initiating the FDA Pre-cert pilot program. This sharing will help the FDA continue to build its expertise in these areas, while giving the agency the information it needs to provide proper oversight of these products and firms. In 2013, the consumer gene-testing company 23andMe Inc. was ordered by the agency to temporarily stop selling its health analysis product until it was cleared by regulators, for example.

As part of the Pre-cert pilot program, participants have agreed to provide access to measures they now use to develop, test and maintain their software products, including ways they collect post-market data.

Once a company passes the FDA test, it will become "pre-certified" which would enable it to potentially "submit less information to the FDA than is now required before marketing a new digital health tool", it said. 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 FDA plans to share public updates about the Pre-cert pilot program via the pilot program webpage as well as through stakeholder meetings, including a January 2018 workshop.

FDA Selects Nine Participants for Digital Health Software Pilot Program