FDA Issues Final Guidance on Medical Devices with Indications Associated with Weight Loss
FDA final guidance titled Medical Devices with Indications Associated with Weight Loss – Premarket Considerations.
Tag Archives: FDA
The 510(k) Pathway in 2026: Navigating a Shifting Regulatory and Political Landscape for Medical Devices
A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. It is a foundation for the U.S. Food and Drug Administration’s (FDA) 510(k) premarket notification process, the primary pathway for new devices to enter the market.
FDA Launches Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot for Chronic Disease Technologies
The FDA announced the TEMPO pilot, an approach to encourage the use of digital technologies that meet people where they are. The pilot supports innovative tools and a health care delivery model that could improve care for millions of Americans managing chronic disease.
FDA 510(k) Clearance for Mendaera Handheld Robotic System
Pioneering a new category of robotics in healthcare, Mendaera’s Focalist™ System, cleared for precise instrument placement during ultrasound-guided procedures for one of medicine’s most common and critical techniques.
GeniPhys receives FDA clearance for self-assembling collagen scaffold
Medtech innovator GeniPhys received 510(k) clearance from the FDA for its platform product, Collymer Self-Assembling Scaffold (SAS).
FDA Takes Action to Address Data Integrity Concerns with Two Chinese Third-Party Testing Firms
FDA issued General Correspondence Letters to two third-party testing companies in China after discovering data that was falsified or otherwise found to be invalid.
FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline
The FDA plans to expand generative AI capabilities—across all centers using a secure, unified platform.
FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities
The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process.
HHS Announces Transformation to Make America Healthy Again
FDA will decrease its workforce by approximately 3,500 full-time employees, with a focus on streamlining operations and centralizing administrative functions. This reduction will not affect drug, medical device, or food reviewers, nor will it impact inspectors.
Taking the Headache out of Maintaining 21 CFR Compliance
Overcoming 21 CFR compliance challenges – stringent equipment maintenance requirements, overwhelming documentation demands, the need to maintain data integrity. Insights into challenges healthcare organizations face with compliance and how to incorporate new tools and processes for streamlining maintenance processes, reducing compliance burdens, and ensuring the highest standards of safety and efficiency.