Medmarc Blog (blog.medmarc.com)
Draft Guidance (3)
FDA Releases New Draft Guidance for the Use of Digital Health Technologies in Clinical Trials
In December 2021, FDA issued draft guidance document titled “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.”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...
DOJ to Ramp up Scrutiny of Clinical Trial Fraud
The U.S. Department of Justice has recently announced several actions in connection with alleged clinical trial fraud, but going forward, this point of emphasis will not be incidental for...
FDA Releases Two Draft Guidance Documents to Advise Manufacturers on Post COVID-19 Protocol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...
FDA Guidance Addresses Definition of Counterfeit Devices
The FDA has published a draft guidance that explains the agency’s authority to destroy counterfeit devices, an authority the agency did not enjoy until passage of the Safeguarding Therapeutics...
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FDA Posts De Novo Final Rule, Electronic Submissions Draft Guidance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center resumed work recently on its regulatory to-do list with a final rule for applications for de novo devices and a draft guidance for electronic submissions.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...
Are You in Compliance with FDA Post-approval Study Requirements?
On May 27, 2021, the FDA issued two draft guidances for studies of devices after approval or clearance. The draft guidances would impose much shorter timelines for both post-approval studies and...
Are You Remanufacturing or Servicing the Product?
On June 17, 2021, the FDA issued a draft guidance for remanufacturing medical devices. With this guidance, the FDA aims to distinguish between remanufacturing and servicing and to instruct the...