Medical Design & Outsourcing

FDA removes pediatric VADs from device shortage list, adds others

The FDA has removed pediatric ventricular assist bypass devices (VADs) from its device shortage list in an update this month.
Regulatory Affairs Professionals Society

FDA warns device maker, contract testing lab for GMP violations

The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for ...
FedTech Magazine

FDA Tightens Its Medical Device Cybersecurity Guidance

Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.
Regulatory Affairs Professionals Society

This Week at FDA: Reactions to FDA’s Bayesian methods guidance, GDUFA science report, and ...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, ...
MD&M East

FDA Ditches Application of Medical Device Rules to Lab-Developed Tests

FDA has scrapped a final rule that was implemented in May 2024, which required the application of medical device rules to laboratory-developed tests. The new rule, effective September 19, 2025, ...

Intuitive Surgical flagged by FDA over medical device issue

Intuitive Surgical (ISRG) stock dips as the FDA issues a safety alert linked to its da Vinci robotic surgical system. Read ...
MD&M East

FDA Warns of Concerning New Radiofrequency Microneedling Device Complications

FDA has issued a new warning to consumers regarding certain uses of radiofrequency microneedling devices. FDA claims that it has seen several serious complications caused by consumers using ...