Medmarc Blog (blog.medmarc.com)
Draft Guidance (2)
FDA Enables Safeguarding Therapeutics Act in Guidance
The FDA has had the authority to destroy counterfeit drugs since 2012, when Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA), but Congress did not grant the...
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The FDA has released a draft guidance for computer software assurance (CSA), which when finalized will represent a significant change in how the agency regulates computer systems used in device...
Three Years Since the Draft Guidance was Released, FDA Issues their Final Guidance Document on Clinical Decision Support Software
On September 28, 2022, FDA released their 26-page final guidance document titled, “Clinical Decision Support Software.” This much anticipated final guidance document aims to set out which types...
FDA Releases Draft Guidance for Remote Regulatory Assessments
The FDA has released a draft guidance for its use of remote regulatory assessments (RRAs), which is an outgrowth of the virtual inspections the agency conducted during the COVID-19 pandemic. These...
Comment Period Closes for FDA’s Draft Guidance Document, "Risk Management Plans to Mitigate the Potential for Drug Shortages"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...
FDA Reissues 2018 Draft Guidance for Cybersecurity
The FDA has released a draft guidance for cybersecurity in medical devices, which is a revised version of a similar document published in October 2018.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 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...
Preparedness Emphasized in FDA Voluntary Recall Guidance
The FDA final guidance for voluntary recalls applies to all FDA product centers, devices and drugs included, and offers some clarity regarding terminology. However, the agency urged companies to take...
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 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...