FDA said it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths. The agency identified those unique cases from a total of 660 adverse event reports in the U.S. from 2010 through September 2018, including 246 new adverse event reports since 2017. FDA began reporting on cases […]
Center for Devices and Radiological Health (CDRH)
FDA launches pilot to shorten some 510(k) approval times
The FDA has launched an interactive pilot program to streamline the 510(k) application for certain moderate-risk devices ranging from percutaneous catheters to lacrimal stents and intubation sets. The Quality in 510(k) “Quik” Review Program uses the agency’s eSubmitter software to format each submission and accepts 39 product codes for device types that it considers to be well-understood by the […]
Here’s how you can teach the FDA a thing or two
Medical device manufacturers, the FDA would like to pay you a visit. As part of its experiential learning program, the agency’s Center for Devices and Radiological Health (CDRH) wants to send its premarket review staff out in the field to learn about industry practices, innovative technologies, regulatory impacts and needs, and how patient perspective and […]
Report: FDA plans reorganized “super office” for device regulation
The FDA is planning a new “super office” for its Center for Devices and Radiological Health department and the soon-to-be created Office of Product Evolution and Quality, according to a Regulatory Affairs Professionals Society report. The new office will aim to support a new dynamic and overcome existing separations of functionality within the FDA to […]
FDA’s CDRH to expand Digital Health Pre-Cert program
The FDA’s Center for Devices and Radiological Health is looking to expand its digital health pre-certification pilot program by the end of 2018, according to a report from the Regulatory Affairs Professionals Society. Testing is slated to continue on the pilot program through to December with more participants joining the initial nine selected last December, […]
FDA’s Shuren says cell phone RF exposure is safe in light of NTP animal study
The FDA today reiterated its view that radiofrequency energy exposure associated with cell phone use is safe in light of a new study from the National Toxicology Program, which indicated a carcinogenic effect in rats. The study, conducted by the National Institute of Health’s National Institute of Environmental Health Sciences, aimed to evaluate the the […]
FDA releases top 3 medical device regulation goals
FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paper that FDA’s CDRH released today. The agency said the priorities further its overall goal of providing Americans with more timely access to the latest high-quality, safe and effective medical devices. […]
FDA proposes easing of medical device malfunctioning reporting
Today’s Federal Register includes a new FDA proposal that is meant to streamline voluntary malfunction summary reporting for medical device companies. The proposal – which is now under a comment period until Feb. 26, 2018 – would allow a medtech company to provide certain malfunction medical device reports (MDRs) in a summary format on a […]
Should the medical device industry pay user fees to CMS?
Achieving reimbursement from payers has become a major challenge for medical device companies. Could the solution lie in having them pay user fees to CMS – the way they do to FDA? That was the question floated by Nadim Yared, president of CVRx and the current chairman of AdvaMed, during this week’s Medtech Conference powered by […]
How to work with the new FDA
Here’s how medical device makers can capitalize on the strategic priorities and transparency initiatives at FDA’s CDRH. Lisa Olson, RCRI Scott Gottlieb has now settled into his role as FDA’s new commissioner and is putting his stamp on the agency. Interestingly, he has started with some very specific points of focus that have bubbled to […]
FDA unveils Digital Health Pre-Certification Program
The FDA today revealed its Digital Health Innovation Action plan, including a new software Pre-certification Program through which the FDA would shift its regulatory focus from the product to the developers for digital health companies. The federal watchdog said that the program looks to shift its oversight of digital health software and tech as software […]