Changes to FDA Regulation of Health-Related Apps

Changes to FDA Regulation of Health-Related Apps

On July 27th of this year, the FDA announced its Digital Health Innovation Action Plan, which is intended to speed up the process(es) associated with bringing innovations in digital health to market. It was developed by the FDA’s Center for Devices and Radiological Health (CDRH) and outlines its intent to streamline the process of software application (including mobile medical apps) and device approval. On July 27th of this year, the FDA announced its Digital Health Innovation Action Plan, which is intended to speed up the process(es) associated with bringing innovations in digital health to market. It was developed by the FDA’s Center for Devices and Radiological Health (CDRH) and outlines its intent to streamline the process of software application (including mobile medical apps) and device approval.

The Digital Health Innovation Action Plan is the FDA’s attempt to simplify and speed up processes that were set forth in the 21st Century Cures Act, which was enacted in December of 2016.

What’s Included in the Digital Health Innovation Action Plan?

The plan is comprised of three parts:

1. “Issuing new guidance implementing legislation”The 21st Century Cures Act regulated certain medical devices that encouraged healthier lifestyles, such as Fitbits. The Digital Health Innovation Action Plan removes those types of products and their associated applications from the list of medical devices that require regulation.

2. “Reimagining digital health product oversight”Reimagining refers to the FDA’s new approach for allowing certain medical devices and applications to be brought to market sooner. They developed a pre-certification program that will eliminate the need for premarket submission, while allowing for quicker approval in the event a product requires a more discerning review.

3. “Growing our expertise”One of the FDA’s goals is to enhance their expertise in digital health, which is, according to the FDA, to “build a cadre of experts with a deep understanding and experience with software development and its application to medical devices.” This hiring initiative will assist the FDA in improving the “quality, predictability, consistency, timeliness, and efficiency of decision making on individual products and firms.” The FDA believes hiring experts in their field will safely speed up the approval process of medical devices and software applications.

The plan, according to the FDA, “lays out the CDRH’s vision for fostering digital health innovation while continuing to protect and promote the public health.” In short, the FDA’s Digital Health Innovation Action Plan is designed to allow consumers quicker access to high-quality, safe and effective medical technology.

Comments are closed.