Medmarc Blog (blog.medmarc.com)
FDA Seeks Budget Authority Increase of 10% in Fiscal Year 2024
The Office of Management and Budget has released a budget request for fiscal year 2024 for all departments of the federal government, including a proposed budget for the FDA. This includes an...
Device User Fees Set to Rise Significantly in Fiscal 2023
The FDA has released the user fee schedule for fiscal year 2023 per the terms of the new user fee agreement, and device manufacturers will see considerably higher fee amounts. One example is that the...
Congress Passes FDA User Fee Legislation
The U.S. Congress has passed legislation that reestablishes the FDA user fee programs for medical devices and pharmaceuticals as part of a continuing resolution for the federal fiscal year 2023...
FDA Electromagnetic Compatibility Guidance Covers Investigational Devices
The FDA has released a final guidance for electromagnetic compatibility (EMC) for medical devices, a policy that applies to PMA, 510(k), and de novo devices. However, the scope of the guidance also...
FDA Releases Draft Guidance for Remote Regulatory Assessments
The FDA has released a draft guidance for its use of remote regulatory assessments (RRAs), which is an outgrowth of the virtual inspections the agency conducted during the COVID-19 pandemic.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
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
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FDA Reissues 2018 Draft Guidance for Cybersecurity
The FDA has released a draft guidance for cybersecurity in medical devices, which is a revised version of a similar document published in October 2018.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,...