Digital Health Company Seeks Guidance in Navigating FDA Policy
Key Facts
- The company offers a women’s health tracking application and separately manufactures Bluetooth FDA Class 1 medical devices
- Assisted the company with the development of corrective actions to address inspection deficiencies related to its Class 1 medical device
- Our work included preparing an extensive advocacy position paper that was submitted to the FDA
The Situation
Mintz assisted a digital health company with the development and implementation of corrective actions to address inspection deficiencies in good manufacturing processes (GMP) related to its Class 1 medical device. This digital health company offers a separate women’s health tracking application. During the inspection, FDA took the position that the mobile application was itself a regulated device, requiring a 510(k) submission. We advocated against that conclusion — in writing — during negotiations with FDA.
The Approach
Our work included preparing an extensive advocacy position paper that was submitted to the FDA, and we argued that the application of FDA policy regarding enforcement discretion for certain mobile applications was appropriate in this case. Our team collaborated to communicate with both the district office and central Center for Devices and Radiological Health (CDRH) team members regarding this issue.
The Outcome
This matter is representative of an ongoing challenge navigating the FDA’s “reimagined” policy on digital health.
Supporting Professionals
Bethany Hills, the lead attorney on this matter, is a member of the firm’s Health Law Practice and Chair of the Firm’s FDA Practice. Benjamin Zegarelli, an Associate in the Firm’s Health Law Practice, provided assistance.
