Medmarc Blog (blog.medmarc.com)
Congress Passes Semiconductor Legislation
President Joseph Biden has signed the CHIPS and Science Act of 2022, legislation that will make $52 billion in subsidies available to U.S. semiconductor manufacturers and billions more toward basic...
Semiconductor Shortage Still a Concern for Device Makers
The shortage of semiconductors continues to present problems to the medical device industry, a critical issue for patients in need of devices that are largely or entirely dependent on these products....
House User Fee Bill Emphasizes Inspections
The House of Representatives is processing legislation to renew the FDA’s user fee programs, a bill that includes a number of key provisions for drug and device makers alike. The bill is likely to be...
FDA Reissues 2018 Draft Guidance for Cybersecurity
The FDA has released a draft guidance for cybersecurity in medical devices, which is a revised version of a similar document published in October 2018. If enacted as a final guidance as written,...
FDA’s Device Center Issues Two Guidances for Appeals
The FDA has released two guidances for appeals of regulatory decisions, one each for mammography facilities and the other for medical device premarket reviews. These are the first two final guidances...
Preparedness Emphasized in FDA Voluntary Recall Guidance
The FDA final guidance for voluntary recalls applies to all FDA product centers, devices and drugs included, and offers some clarity regarding terminology. However, the agency urged companies to take...
Major Regulatory Changes May Be Underway in U.K.
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed to overhaul its regulatory framework for medical devices that will span all medical technologies. The...
FDA, Health Canada, and Medicines and Healthcare Products Regulatory Agency (MHRA) Release Guiding Principles for the Development of Good Machine Learning Practice for AI/ML Medical Devices
The U.S. Food and Drug Administration (FDA) has come together with other international Public Health counterparts to outline a set often guiding principles related to medical devices that use...
FDA Posts De Novo Final Rule, Electronic Submissions Draft Guidance
The FDA’s device center resumed work recently on its regulatory to-do list with a final rule for applications for de novo devices and a draft guidance for electronic submissions. While the...
CMS Announces Full Withdrawal of MCIT Rule
The Centers for Medicare & Medicaid Services has fully withdrawn the rule for Medicare Coverage of Innovative Technology (MCIT), which eliminates any prospect for automatic coverage of...