Medmarc Blog (blog.medmarc.com)
FDA
FDA Offers 60-day Compliance Window for Human Factors Guidance
The FDA has released a guidance for human factors engineering (HFE) in medical devices, a guidance that spans 46 pages and is not explicitly restricted to specific device types. One of the key...
FDA Announces Home Health Challenge to Reduce Readmissions
The FDA has announced an innovation challenge for medical technology to be used in the home setting with the objective of reducing hospital readmissions. The READI-Home Innovation Challenge will...
FDA Unveils Upgrades for the Agency’s Elsa AI Agent
The FDA has upgraded its Elsa artificial intelligence (AI) agent, which is now on its fourth iteration in less than a year. The upgrade comes with the integration of a data platform that will...
CMS, FDA Propose New Path for Breakthrough Devices
The Centers for Medicare & Medicaid Services and the FDA recently announced a new program that will create a more predictable route for adoption of innovative medical devices. The Regulatory...
Next-generation Sequencing (NGS) the Focus of FDA Gene Therapy Guidance
The FDA has released a draft guidance on the safety assessment of gene editing as part of the agency’s framework for accelerating the development of therapies for ultra-rare diseases. The April...
FDA Updates Patient Preference Guidance
A The FDA has released the final guidance on the use of patient preference information (PPI), an update of an earlier guidance. The new PPI guidance is applicable across the entire product life...
FDA Takes Aim at Personalized Medicine in New Draft Guidance
Personalized medicine has long been the objective of the FDA and its regulated industries, and a new draft guidance from the FDA’s drug and biologics centers would seem to suggest that the era of...
FDA’s Drug, Biologics Centers Release Primary Bayesian Guidance
The FDA’s centers for pharmaceuticals and biologics have released a draft guidance specific to Bayesian methods for support of primary inference in clinical trials. The draft guidance was posted...
FDA’s Software Assurance Guidance Emphasizes Risk Management
The FDA’s guidance for computer software assurance (CSA) is not a groundbreaking policy document, but the guidance provides insight into how much effort a manufacturing site must put into verifying...
FDA’s QMSR Final Rule Now in Effect
The FDA’s Quality Management System Regulation (QMSR) is effective as of Feb. 2, 2026, two years after publication of the QMSR final rule. This new regulatory framework requires that manufacturers...