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Vaporized hydrogen peroxide (VHP) is now an established method of sterilization for medical devices, the FDA said, and can be used in place of ethylene oxide (EtO), which has been under fire for its potential to cause cancer. Read More
How the FDA handles internal scientific disagreements and whether scientists have faced retaliation for expressing differing scientific views is the subject of a letter sent by the House Energy and Commerce Committee to the FDA. Read More
The FDA has issued a warning to patients and health care providers to not use the Synovo Total Hip System including resurfacing implants, manufactured by Synovo Production after 2019, because components of the system have been modified from the cleared device and the safety and effectiveness has not been established. Read More
Encouraging the FDA to put in place rules that govern the use of AI in healthcare is the focus of a letter Rep. Greg Murphy (R-N.C.) has sent to FDA Commissioner Robert Califf, pointing to the need to clarify liability guidance and overlapping governance, both of which he says are undermining manufacturers. Read More
CDRH is now issuing electronic export documents for medical devices instead of paper to improve efficiency, reduce the amount of time it takes for a manufacturer to receive export documents, and decrease environmental burden. Read More
The FDA is increasingly finding cybersecurity lapses during inspections of medical device manufacturing facilities — and most often because cybersecurity risk management is not fully documented as part of design controls, according to compliance expert Eric Henry. Read More
The FDA is seeking input from a wide variety of stakeholders on a draft report on best practices for streamlining the development, dissemination and use of guidances. Read More