The FDA has issued final guidance clarifying what it considers permissible off-label information for device makers and drug companies to convey to potential customers. A pair of guidance documents outlines how medtech and pharmaceutical companies can explain to payors and hospitals how their products can affect outcomes and potentially save money, beyond what the products’ indication with the
Here’s how FDA officials think you can legally promote off-label device, drug uses
June 13, 2018 By 2 Comments
FDA launches medical device innovation challenge to combat opioid crisis
May 30, 2018 By Leave a Comment
The U.S. FDA today announced that it has launched an innovation challenge to encourage the development of medical devices to help reduce the country’s opioid abuse crisis. The hope is that the challenge will result in new medtech including digital health technologies and diagnostic tests to help detect, treat and prevent addiction, according to FDA. Go
Is FDA’s easing of medical device malfunctioning reporting a good thing?
May 2, 2018 By Leave a Comment
The news came out in 2016 that medical device companies were late filing more than 300,000 adverse events reports to U.S. FDA. “I think that’s simply embarrassing as an industry,” regulatory consultant Mike Drues said during his latest podcast with Medical Design & Outsourcing. FDA’s solution has partly been to propose an easing of the reporting requirements.
FDA reschedules eMDR system update
March 30, 2018 By Leave a Comment
The FDA recently announced that the eMDR adverse event code update that was originally set to take place on April 6 has been rescheduled for July 5. The delay in update will give AS2 submitters more time to develop and validate changes to adverse event compliant handling system with the test eMDR system that was
FDA removed 10% of medtech establishments from its registration database: Here’s why
February 20, 2018 By 1 Comment
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
January 30, 2018 By Leave a Comment
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
January 29, 2018 By Leave a Comment
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
January 24, 2018 By Leave a Comment
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
January 24, 2018 By Leave a Comment
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
January 17, 2018 By Leave a Comment
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
January 17, 2018 By Leave a Comment
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
December 29, 2017 By Leave a Comment
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>>
FDA proposes easing of medical device malfunctioning reporting
December 22, 2017 By Leave a Comment
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?
December 5, 2017 By Leave a Comment
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
December 5, 2017 By Leave a Comment
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
