FDA proposes easing of medical device malfunctioning reporting

A new FDA proposal 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 quarterly basis – instead of

Medical device value: Here’s how you work it into your design

Public and private payers are increasingly demanding that health providers manage their patient populations more effectively and efficiently. That means that medtech companies can no longer merely rely on the strength of their technology to achieve reimbursement. They need to demonstrate “value,” too. “There’s a lot going on with the healthcare payment delivery systems to reform

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