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Medmarc Blog (blog.medmarc.com)

FDA Releases Draft Guidance for Remote Regulatory Assessments

September 13, 2022

The FDA has released a draft guidance for its use of remote regulatory assessments (RRAs), which is an outgrowth of the virtual inspections the agency conducted during the COVID-19 pandemic. These...

FDA Finalizes Rule for Over-the-Counter Hearing Aids

September 08, 2022

The FDA released the final rule for over-the-counter (OTC) hearing aids, which the agency said may assist nearly 30 million Americans in obtaining safe and effective devices at a lower cost than...

Congress Passes Semiconductor Legislation

August 04, 2022

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

July 25, 2022

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

May 16, 2022

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

April 28, 2022

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...

April 27, 2022

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FDA Reissues 2018 Draft Guidance for Cybersecurity

April 11, 2022

The FDA has released a draft guidance for cybersecurity in medical devices, which is a revised version of a similar document published in October 2018.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

March 30, 2022

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...