Medmarc Blog (blog.medmarc.com)
Medical Device
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...
FDA Releases Prior Knowledge Draft for Gene Therapy
The FDA has published a draft guidance that would permit makers of gene therapy (GT) products to leverage prior knowledge in their product development programs. The draft indicated that the agency is...
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...
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...
Evolving Labels and Warnings for AI-Enabled Devices: Managing Risks
When FDA finalized its guidance on Predetermined Change Control Plans (PCCPs) and, shortly after, joined Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in...
FDA Guidance on AI Medical Devices: Predetermined Change Control Plans
One of the challenges regulators face with AI-enabled medical devices is that they are not static products. Unlike a traditional implant or diagnostic tool, the device that receives FDA approval may...
Patients, Manufacturers Plead for Medicare Breakthrough Device Coverage
A group of 67 patient groups and life science organizations has petitioned the Centers for Medicare & Medicaid Services for coverage of breakthrough medical devices. The request comes at a time when...