Medmarc Blog (blog.medmarc.com)
FDA Seeks Feedback on AI in Drug Development, Manufacturing
The FDA is working to adapt its regulatory regimes to the use of artificial intelligence (AI) across the agency’s product centers, a response to the frequent use of AI for a variety of regulated...
FTC Proposes to Prohibit Non-compete Clauses in Employment Contracts
The Federal Trade Commission has proposed to ban the practice of adding non-compete clauses to employment contracts, which the FTC states are an impediment to competition. In comments on the...
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FDA Releases Draft Guidance for Remote Regulatory Assessments
The FDA has released a draft guidance for its use of remote regulatory assessments (RRAs), which is an outgrowth of the virtual inspections the agency conducted during the COVID-19 pandemic.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....