In an effort to facilitate greater market access for new and advanced healthcare technologies, the U.S. Food and Drug Administration (FDA) has released a formal plan to clarify its policies regarding the regulation of mobile medical applications, wearable devices and other digital health products.
Issued in late July, the agency’s Digital Health Innovation Action Plan was developed by the Center for Devices and Radiological Health (CDRH) and presents its vision for fostering ongoing innovation in digital health technologies while continuing to promote public health and protect public safety.
In brief, the Plan anticipates the following actions by the CDRH:
- Issuing a series of additional draft guidance documents to provide clarity on the medical software provisions of the 21st Century Cures legislation;
- Initiating a pilot program that would pre-certify certain digital health developers who meet defined quality criteria; and
- Building the agency’s expertise in digital health technologies through the hiring of new staff and establishing an Entrepreneurs in Residence program.
Read the complete text of the FDA’s Digital Health Innovation Action Plan.
The FDA is planning a public workshop for early 2018 to discuss its Action Plan and to obtain additional input from all stakeholders. The FDA is also encouraging comments on its Plan (Public Docket FDA-2017-N-4301) through the U.S. Government’s Regulations portal at www.regulations.gov.
