FDA removed 10% of medtech establishments from its registration database: Here’s why

David Lennarz, Registrar Corp. The U.S. FDA has removed 2,546 medical device establishments from its active registration database.  As of Feb. 19, the FDA database contained 24,578 registered establishments, compared to 27,124 registered establishments on Feb. 2. So why did FDA remove the registrations? Establishments are typically removed due to failure to renew their annual

Webinar: The top medtech stories of 2017

This webinar was presented live on Tuesday, January 30, 2018. Click below to watch on demand.     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

Medical device startups: Here’s how you handle requirements

Developing the product requirements is one of the most complex activities associated with product development, yet one of the most important.  Bill Betten, Betten Systems Solutions This is the third in a series of articles that discusses the design of innovative products in the highly regulated medical environment. The previous two articles focused on the

FDA, FTC warn companies over deceptive opioid cessation products

The FDA and the Federal Trade Commission have posted joint warning letters to companies that make and distribute opioid cessation products. The two watchdogs warned that the companies are illegally marketing their unapproved products as treatments or even cures for people with opioid addiction and withdrawal. Selling unapproved products as therapies for opioid addiction is

How FDA’s digital health plan is shaking up its review process

FDA is asking questions about how to overhaul digital health product regulation and relying on expertise within the industry to do so, according to Bakul Patel, FDA’s associate center director for digital health, who recently spoke with MDO. In late 2017, FDA launched the Digital Health Innovation Action Plan. Within that plan is a recipe

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

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