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 needs to improve medical device regulation, GAO says

FDA is lacking performance metrics when it comes to tracking whether its medical device regulators are following a “least burdensome” approach toward asking applicants for additional information, according to a new report from the U.S. Government Accountability Office. The GAO says in the report highlights: “Until such measures are developed and used, FDA will not

Webinar: The top medtech stories of 2017 – Jan. 30

Tuesday, January 30, 2018 2:00pm ET / 11:00 PT     The medtech industry saw its transformation accelerate in 2017: Whether it’s the roster of largest companies, business models or the regulatory environment, times are a-changing. Competition is also heating up in areas including diabetes care and robotic surgery. MDO’s managing editor Chris Newmarker will

7 top stories that mattered for medtech in 2017

The medtech industry saw its transformation accelerate in 2017: Whether it’s the roster of largest companies, business models or the regulatory environment, times are a-changing. Competition is also heating up in areas including diabetes care and robotic surgery. Here are seven stories that mattered for the medical device industry this year. Next>>

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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

Biomaterials: Is there a better way for FDA to regulate them?

The medical device industry is pretty conservative when it comes to materials used in medical devices. That begs the question: Do we need a new FDA approval pathway for biomaterials? Mike Drues thinks the answer is “yes.” “It really will encourage companies to use new materials and not be hamstrung with materials that have been

FDA publishes final guidance for UDI direct marking requirements

David Lennarz, Registrar Corp. The U.S. Food and Drug Administration (FDA) requires devices intended to be reprocessed or devices intended to be used more than once by multiple patients to physically bear a permanent unique device identifier (UDI) marking that lasts the duration of the devices’ expected lifetime. This is known as UDI direct marking. The

3D printing could expand medical device regulation: Here’s how

FDA today offered a clearer picture of how it plans to regulate the 3D printing of medical devices – including in non-traditional settings such as medical facilities and academic institutions. “In order to help ensure the safety and effectiveness of these products, we’re working to establish a regulatory framework for how we plan to apply

FDA’s Gottlieb updates on Puerto Rico and medical product shortages

FDA commissioner Dr. Scott Gottlieb provided an update today to the work that the agency is doing to help medical device manufacturers in Puerto Rico in the weeks following Hurricanes Irma and Maria. The FDA chief noted that even though some major medical product manufacturers have regained power, many firms continue to run on generator

Report: Q3 medical device recalls down 39%

Medical device recalls have declined 39% for the third quarter, settling at 167, the lowest quarter the US has seen since the fourth quarter of 2011, according to a new Stericycle Expert Solutions report. Recalled units were up, however, rising 1% to 68 million which positioned it higher than 16 of the last 19 quarters, […]

Who got picked for FDA’s digital health pre-cert pilot?

FDA has announced the names of the companies selected to participate in its digital health pre-cert pilot – a first-of-its-kind program aimed to revolutionize digital health regulation in the U.S. Dr. Scott Gottlieb, FDA’s commissioner, announced the nine participants of FDA’s digital health software precertification pilot program (FDA Pre-cert) last week during his keynote address at the

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

FDA seeking to prevent medical device shortages from hurricanes

The U.S. FDA has been seeking to prevent shortages of medical devices and other products after disruptions caused by Hurricanes Harvey, Irma and Maria. “These storms have hit hard in areas where there are a significant number of farmers, food distributors, and medical product manufacturers, including Houston, Florida, and now Puerto Rico and the U.S.

FDA’s medical gas guidance offers clarity to manufacturers

FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003. A review under FDASIA in 2015 noted that minor guidance updates and better inspector training would improve the regulatory […]

Webinar: How late 2017 has changed medtech

This webinar was presented live on Wednesday, October 11, 2017. Click below to watch on demand.       When it comes to news out of the U.S. government: one word could sum up what it means for the medical device industry: “uncertainty.” It was true at the start of 2017. And it is even