Medmarc Blog (blog.medmarc.com)
Medical Device Manufacturers (4)
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 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....
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...
FDA Reissues 2018 Draft Guidance for Cybersecurity
The FDA has released a draft guidance for cybersecurity in medical devices, which is a revised version of a similar document published in October 2018.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 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...
FDA Releases New Draft Guidance for the Use of Digital Health Technologies in Clinical Trials
In December 2021, FDA issued draft guidance document titled “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” The guidance discusses the proper use of...
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...