Medmarc Blog (blog.medmarc.com)
AdvaMed Revises its Code of Ethicsitle Here...
The Advanced Medical Technology Association (AdvaMed) is the largest medical technology association, representing life sciences device, diagnostics, and digital technology manufacturers. The...
FDA Publishes Finalized Guidance Document for Pre-Launch Activities Importation Requests (PLAIR)
On March 2, 2022, the US Food and Drug Administration (FDA) published the finalized guidance document titled, “Pre-Launch Activities Importation Requests,” or PLAIR. This document was updated from...
FDA Strives to Harmonize 21 CFR Part 820 with ISO 13485:2016
The Food and Drug Administration (FDA) has continued to move towards harmonizing U.S. regulations with international standards for the regulation of medical devices. On February 23, 2022, FDA...
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FDA Releases New Draft Guidance for the Use of Digital Health Technologies in Clinical Trials
In December 2021, FDA issued draft guidance document titled “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.”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...
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FDA Releases Two Draft Guidance Documents to Advise Manufacturers on Post COVID-19 Protocol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...
Congress Pushes CMS to Reconsider MCIT Program
The Centers for Medicare & Medicaid Services has formally scuttled its proposal to cover breakthrough medical devices, but recent developments have breathed new hope into the Medicare Coverage...