02 Aug FDA announces the launch of the Digital Health Software Pre-certification Pilot Program
In recent years, the Food and Drug Administration (FDA) has taken several steps to streamline and refine the regulatory approval process for health technology, an effort that accelerated substantially following the appointment of Dr. Scott Gottlieb as FDA Commissioner. As a next step in the process, the FDA recently announced that applications for a new Software Pre-certification (PreCert) Pilot Program are being accepted beginning Aug. 1, with a planned program launch date of Sept. 1, 2017. The goal of the PreCert program is to evaluate new approaches for regulatory approval of health focused software products, and the creation of a pre-certification program for companies that perform high-quality software design and testing.
The FDA is seeking input from volunteers to help design a regulatory framework that is responsive to the faster development and innovation cycles for health technology software devices, with the goal of improving patient access to new software technology. The outcome of this PreCert program may reduce the time and cost of market entry for software developers who are determined to be reliable manufacturers of high-quality, safe and effective digital health products.
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