Medmarc Blog (blog.medmarc.com)
510(k)
New FDA Draft Guidance Offers Clarity for 510(k) Requirements
The FDA has released a new draft guidance which explains when clinical data may be needed for 510(k) submissions, an essential explanation of the agency’s policy for the 510(k) program. When...
FDA Releases Draft Guidance for Implanted 510(k) Devices
In September 2023, the FDA published several new draft guidance documents for Class II, moderate-risk devices as part of the agency’s agenda to modernize the 510(k) program. One of these is a draft...
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...
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 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FDA Releases Two Draft Guidance Documents to Advise Manufacturers on Post COVID-19 Protocol
During the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) felt pressured to expeditiously authorize new medical devices that could protect the public. Medical equipment such as...
Major Regulatory Changes May Be Underway in U.K.
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed to overhaul its regulatory framework for medical devices that will span all medical technologies. The...
FDA, Health Canada, MHRA Release AI/ML Medical Device Guiding Principles
The U.S. Food and Drug Administration (FDA) has come together with other international Public Health counterparts to outline a set often guiding principles related to medical devices that use...
FDA Posts De Novo Final Rule, Electronic Submissions Draft Guidance
The FDA’s device center resumed work recently on its regulatory to-do list with a final rule for applications for de novo devices and a draft guidance for electronic submissions. While the...
FDA to Resume Domestic Device Inspections
The FDA was forced to announce in March 2020 that it would suspend inspections of drug and medical device manufacturing sites because of the COVID-19 pandemic, but the agency has partially...