Medmarc Blog (blog.medmarc.com)
FDA
FDA Moves into Oversight for Current, Future Robotic Surgical Systems
The FDA’s Center for Devices and Radiological Health has issued a draft guidance for robotically assisted surgical devices (RASDs), addressing the content of premarket submissions for these products....
FDA Moves Decisively on Alternatives to Animal Testing
The FDA announced Sept. 21 that it has issued a direct final rule to amend the language found in regulations pertaining to preclinical testing of pharmaceuticals and biotech products. As an example,...
FDA’s Device Center Leans in on Regulatory Reliance
The FDA’s Center for Devices and Radiological Health (CDRH) has opened a webpage to facilitate industry’s use of regulatory reliance, which allows national regulatory authorities to make more...
IMDRF Posts Guidance for Predetermined Change Control Plans
The International Medical Device Regulators Forum (IMDRF) has posted a guidancefor predetermined change control plans (PCCPs), a vital document for regulatory harmonization. The scope of this IMDRF...
FDA Seeks Feedback on Oversight of Generative Artificial Intelligence
The FDA has posted a request for information (RFI) for the use of generative artificial intelligence (generative AI), asking stakeholders to opine on matters such as the risks inherent to the use of...
CMS Releases RAPID Proposal for Medicare Device Coverage
The Centers for Medicare & Medicaid Services has posted a draft version of the Regulatory Alignment for Predictable and Immediate Device Coverage Pathway (RAPID), a program first announced by CMS and...
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 Announces Home Health Challenge to Reduce Readmissions
The FDA has announced an innovation challenge for medical technology to be used in the home setting with the objective of reducing hospital readmissions. The READI-Home Innovation Challenge will...
FDA Unveils Upgrades for the Agency’s Elsa AI Agent
The FDA has upgraded its Elsa artificial intelligence (AI) agent, which is now on its fourth iteration in less than a year. The upgrade comes with the integration of a data platform that will...
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...