The FDA says it will work with some of the best-known manufacturers of consumer goods, wearables, medical devices and pharmaceuticals to test how it can speed up regulatory approvals by pre-certifying companies that demonstrate to the FDA rigorous development processes.

The Food and Drug Administration says it wants to streamline the process of approving digital healthcare products for consumer and industry use.

To do that the FDA says it will work with some of the best-known manufacturers of consumer goods, wearables, medical devices and pharmaceuticals to test how it can speed up regulatory approvals by pre-certifying companies that demonstrate to the FDA rigorous development processes.

To that end, the FDA announced yesterday that it will work with nine companies—Apple Inc., Fitbit Inc., Johnson & Johnson, Pear Therapeutics Inc., Phosphorus Inc., Roche Holding AG, Samsung, Tidepool and Verily Life Sciences LLC—on a pilot program for faster digital healthcare product review.

What’s different about this initiative is that rather than approving a single digital healthcare product or service at a time—a process that can take anywhere from a few months to many years depending upon the type of product—that FDA wants to work with the nine companies to “pre-certify” a company’s technology and workflow process or procedures.

We need to modernize our regulatory framework .

For example, instead of approving each new health app or device from Apple and Fitbit or a new web-enabled medical device from Johnson & Johnson, the FDA hopes to be able to fast track approvals from companies that have met FDA standards for developing and testing new products.

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“The pilot program is intended to inform a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product,” says FDA Commissioner Scott Gottlieb. “The goal of this new approach is for the FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets quality standards and if so, to ‘precertify’ the company.”

As part of the pilot program, each of the nine companies has agreed to provide access to measures they use to develop, test and maintain their software products, including ways they collect market data. The companies also agreed to be available for site visits from FDA staff and provide information about their quality management system, the agency says.

“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices,” Gottlieb says. “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.”

After being hands off for many years, the FDA says it is now taking a much more hands-on approach to providing regulatory oversight for digital healthcare.

Until now FDA approval for new forms of digital healthcare products have been slow mainly because of older ways of regulating medical device products that weren’t suited for digital product development, the agency says. For example in the past few years more than 165,000 health and wellness apps have been developed and are now available in Google Play or and Apple App store, but since 2013 the FDA has only approved about 100 apps.

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“The challenge FDA faced in the past is determining how to best regulate these non-traditional medical tools with the traditional approach to medical product review,” Gottlieb says. “FDA’s traditional approach to medical devices is not well suited to these products.”

 

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