Medmarc Blog (blog.medmarc.com)
AdvaMed
FTC Not on Board with DOJ Second Request Revision
The U.S. Department of Justice (DOJ) announced recently it will revise its approach to second request investigations in the hope of making the second request process for mergers and acquisitions more...
FDA Releases Draft for Sixth Device User Fee Agreement
The FDA’s Center for Devices and Radiological Health has released a draft version of the sixth iteration of the Medical Device User Fee Agreement (MDUFA VI), which will govern user fees for fiscal...
FDA Offers 60-day Compliance Window for Human Factors Guidance
The FDA has released a guidance for human factors engineering (HFE) in medical devices, a guidance that spans 46 pages and is not explicitly restricted to specific device types. One of the key...
Electronic Labeling Bill in Process in the U.S. Senate
Congress is considering several bills that may affect companies in the life sciences, particularly in connection with medical devices and in vitro diagnostics. One bill that is in play in the...
CMS, FDA Propose New Path for Breakthrough Devices
The Centers for Medicare & Medicaid Services and the FDA recently announced a new program that will create a more predictable route for adoption of innovative medical devices. The Regulatory...
SBIR/STTR Reauthorization Strengthens Early Stage Medtech Innovation
After a six-month hiatus, the Small Business Innovation Research (SBIR) and the Small Business Technology Transfer (STTR) programs are in effect thanks to passage of a bill that was signed into law...
AdvaMed Proposes Medtech MAHA in Response to Section 232 RFI
The U.S. Department of Commerce (DoC) has opened an investigation into the national security implications of trade relations for a variety of products, including medical devices. The Advanced...