On September 26, 2017, the FDA announced that it has chosen nine tech companies to participate in a pilot program (FDA Pre-Cert) to help tech companies bypass some regulations that have hindered health software and products release, Bloomberg reports. According to the Bloomberg article, this program operates as a “fast track” for these technology companies, which amongst others include Apple, Fitbit, Samsung, Johnson & Johnson, and Verily Life Science (an arm of Google parent Alphabet Inc.), and is said to allow them to develop technologies rapidly, while allowing the FDA to maintain oversight over those projects.
This program is said to signal a broader trend at the FDA to streamline regulation since FDA Commissioner Dr. Scott Gottlieb was appointed in May. Bloomberg reports that as technology companies have entered the healthcare and medical device arena, questions arose of whether these companies were required to seek FDA approval on their products. For example, 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. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” Commissioner Gottlieb said.
As Fortune reports, the pilot companies can potentially get their products pre-cleared in lieu of undergoing the FDA’s traditional medical device regulatory framework. Under FDA Pre-Cert, the FDA will instead primarily examine the software (rather than the tech device itself) and inspect facilities to ensure it meets the FDA’s rigid standards. If the companies pass the audit, the companies will attain pre-certified status. The FDA Pre-Cert was launched as part of the agency’s Digital Health Innovation Action Plan. The press announcement states that the “plan seeks to outline[] 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.” The FDA plans to share public updates via the pilot program webpage as well as through stakeholder meetings, including a January 2018 workshop.
For more information on the FDA’s Pre-Cert press release, please visit the site here.