Medmarc Blog (blog.medmarc.com)
Supply Chains
AdvaMed Presses Senate on Urgency of Tariff Relief for Medical Devices
Tariffs placed on medical devices could impede patient access to these lifesaving products, an argument made by Scott Whitaker, President and CEO of the Advanced Medical Technology Association...
AdvaMed AI Roadmap Prods Washington to Keep Pace
The Advanced Medical Technology Association (AdvaMed) has published a policy roadmap for artificial intelligence (AI), identifying the tremendous benefits AI has to offer patients. However, AdvaMed...
Tariffs Again in Play as Trade Tensions Mount
The global trade picture for medical devices has become more complicated in the first weeks of 2025 as the U.S. has threatened to apply tariffs to a series of trading partners across the globe....
FDA Revisits Validation for Production Computer Systems
The FDA has released a draft guidance for computer software assurance (CSA), which when finalized will represent a significant change in how the agency regulates computer systems used in device...
President Biden Signs Executive Order to Launch a National Biotechnology and Biomanufacturing Initiative
On Monday, September 12, 2022, President Joe Biden signed an Executive Order to launch a National Biotechnology and Biomanufacturing Initiative. The official White House correspondence emphasizes...
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...
Comment Period Closes for FDA’s Draft Guidance Document, "Risk Management Plans to Mitigate the Potential for Drug Shortages"
The COVID-19 pandemic brought to light the fragility of the pharmaceutical supply chain and demonstrated that disruptions can lead to drug shortages. We have written extensively about the...
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....
FDA Attempts to Prevent Future Supply Chain Shortages with a Move towards New Requirements
The U.S. Food and Drug Administration (FDA) released a new guidance document on January 11, 2022 titled “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a...