News from and about the FDA
- The FDA released the guidance document Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval. This is a final guidance following the draft issued on April 23, 2014. This guidance is primarily for medium- and high-risk devices, however with mobile apps that help diagnose or recommend treatment options needing 510(k) certification it may be prudent for anyone considering an app as part of their solution to review this.
Source: FDA Website