Medmarc Blog (blog.medmarc.com)
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...
User Fees Could Reach $1.9 Billion in MDUFA V
Negotiations between FDA and industry regarding the reauthorization of the Medical Device User Fee Amendments (MDUFA V) are complete and the final commitment letter summarizing the deal is expected...
AdvaMed Revises its Code of Ethicsitle Here...
The Advanced Medical Technology Association (AdvaMed) is the largest medical technology association, representing life sciences device, diagnostics, and digital technology manufacturers. The...
FDA Reissues 2018 Draft Guidance for Cybersecurity
The FDA has released a draft guidance for cybersecurity in medical devices, which is a revised version of a similar document published in October 2018.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...
FDA Publishes Finalized Guidance Document for Pre-Launch Activities Importation Requests (PLAIR)
On March 2, 2022, the US Food and Drug Administration (FDA) published the finalized guidance document titled, “Pre-Launch Activities Importation Requests,” or PLAIR. This document was updated from...
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...
FDA Strives to Harmonize 21 CFR Part 820 with ISO 13485:2016
The Food and Drug Administration (FDA) has continued to move towards harmonizing U.S. regulations with international standards for the regulation of medical devices. On February 23, 2022, FDA...
FDA Released Finalized Guidance Document for Combination Products
In January 2022, FDA released a new final guidance document titled, ‘Principles of Premarket Pathways for Combination Products’ which has caused many manufacturers to reevaluate their FDA...
FDA Discussion Paper Addressing 3D Printing of Medical Devices at the Point of Care
The U.S. Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) issued a discussion paper titled, ‘3D Printing Medical Devices at the Point of Care’. FDA...