Earlier this month, the FDA released programmatic guidance intended to clarify the current review practices for the Humanitarian Device Exemption (“HDE”) Program (“Guidance”) reflecting recent changes in the HDE Program resulting from statutory amendments made by the 21st Century Cures. The Guidance addresses frequently asked questions about FDA actions on HDE applications, post-approval requirements, and includes a filing checklist to clarify the required information for the FDA to consider whether an HDE application is ready for substantive review.
Unlike ...
On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the de novo classification process for medical devices, including (1) the format and contents of a de novo request and (2) the criteria for accepting or denying a de novo request. FDA intends to “enhance regulatory clarity and predictability... [and] provide a regulatory framework that sets clear standards, expectations and processes for de novo classification” through this proposed rulemaking.[1]
FDA regulates medical ...
Blog Editors
Recent Updates
- U.S. Supreme Court to Weigh Induced Infringement Case Regarding ‘Generic Version of Vascepa®’
- Closer Look at H.R. 7291: What the “GRAS Oversight and Transparency Act” Could Mean for Dietary Supplements
- Diagnostic Imaging Interoperability Request for Information Shines a Spotlight on the Lack of Patient-Centered Longitudinal Health Records
- DOJ Deputy Assistant Attorney General Addresses FCA Enforcement Priorities and Reinforces Commitment to Robust Enforcement
- Interested in Opening a Medical Spa? (Part III): Here’s (More) That You Need to Know