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

Northwire expands biocompatibility compliance

Northwire (Osceola, Wis.) announced that it has finished additional testing to certify its BioCompatic material line to be in accordance with ISO 10993-10 irritation and skin sensitization requirements. The company’s BioCompatic material is designed to create optimized, safe and dependable medical cables while meeting biocompatibility standards under USP Class VI and compliance to ISO 10993-5 cytotoxicity.

Light-based medical products: What you need to know

Photonics technologies are everywhere but need a deft touch to integrate into light-based medical products. Scott Wohlstein, The Photonics Group Much like electronics is the study of the electron, photonics is the study of the photon and includes its generation/emission, transmission, detection and analysis. Incandescent/fluorescent light sources, UV lamps, lasers, LEDs, lenses, fiber optics, detectors

How laser marking could solve the medical device industry’s UDI challenges

Here are five ways that laser marking could provide advantages to medical device companies when it comes to meeting permanent marking requirements under FDA’s Unique Device Identification program. Ashir Thakore, SABIC As the U.S. Food and Drug Administration (FDA) implements its phased Unique Device Identification (UDI) program across medical device classes, OEMs are considering methods

FDA warns BD over blood collection tubes used in Magellan’s lead testing kit

The FDA issued a warning letter to Becton Dickinson & Co. (NYSE:BDX) today, citing a number of violations of federal law that it identified in an inspection of the company’s New Jersey facility. The inspection, which was done as part of the agency’s ongoing investigation into the cause of inaccurate blood lead tests linked to Magellen […]

Malaysian regulators extend moratorium to summer 2018 for qualifying medical device registrants

Stewart Eisenhart, Emergo Group The Medical Device Authority (MDA), Malaysia’s medical device regulator, will extend a moratorium for companies that have registered for market access but not yet received approval so that they may continue selling in the country as their premarket reviews proceed. Get the full story here at the Emergo Group’s blog. The

Zimmer Biomet wins FDA nod for Sidus stem-free shoulder system

Zimmer Biomet (NYSE:ZBH) said today it won FDA clearance for its Sidus stem-free shoulder system. The newly cleared Sidus system is designed as a total shoulder arthroplasty solution for patients with good bone stock with either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or those who’ve had previous surgeries of the shoulder that […]

Medical device companies need to worry more about liability: Here’s why

Mike Drues has a piece of advice he likes to repeat to clients of his medical device regulatory consulting business: Don’t fear FDA; fear the product liability attorneys. “You should fear the product liability attorneys because they could impose a heck of a lot more damage on a company than the FDA ever could. And by

Medical Device Excise Tax set to return early this year

By Stewart Eisenhart, Emergo Group Despite multi-year efforts to fully repeal the Medical Device Excise Tax (MDET) on device sales in the US, the tax appears set to come back into force in early 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s

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

Report slams European Union’s high-risk medical device approvals rate

A health economics and outcomes research group has concluded that the assessment for high-risk medical devices in the European Union is of low quality and needs improvement. The report appears in the December 2017 issue of Value in Health by ISPOR. The authors looked at 1,376 health technology assessment (HTA) reports filed between 2010 and 2015.

Medical device startups: Here’s how you successfully plan

The development of the product development plan is an evolutionary effort that continues through the life of the medical device project. Bill Betten, Betten Systems Solutions, and Tom Waddell, Waddell Group This is the second in a series of articles that will discuss the design of innovative products in the highly regulated medical environment.  The

FDA refines least burdensome guidance for medical device oversight

Stewart Eisenhart, Emergo Group Medical device regulators at the Food and Drug Administration have updated guidance clarifying what Least Burdensome Provisions mean for US market registrants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com

What is the future of medtech in 2018?

Some of the largest medtech companies showed in 2017 that they are ready to grow through embrace of the new healthcare ecosystem. Medical device companies are putting greater emphasis on value-based arguments for their products and services. They’re putting more attention to clinical and economic research and adopting digital products that incorporate machine learning and

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