FDA introduces IMEDS, a public-private resource for evidence generation

Dr. Robert M. Califf FDA has been working to establish a national resource for FDA-approved medical products that can be used by public and private-sector entities, including regulated industry, to conduct large scale evaluations of safety issues in an environment that is secure and protects patient privacy. These evaluations include epidemiologic studies of medical products

Physio-Control has a battery problem with its LifePak 1000 AED

Physio-Control said last week that it is launching a voluntary field action for its LifePak 1000 defibrillator, after reports that the device can shut down unexpectedly during treatment. The Redmond, Washington–based company has received 34 reports describing instances when customers have attempted to use the LifePak device and it has shut down due to an

FDA warns again on Pentax duodenoscopes

The FDA issued a statement today warning that Hoya (TYO:7741) subsidiary Pentax Medical’s ED-3490TK video duodenoscopes have a potential risk associated with the design and manufacturing of the device. Cracks in the adhesive that seals the scope’s distal cap and tip can lead to microbial and fluid ingress, according to information provided to the FDA by Pentax.

FDA: St. Jude Medical devices really do have a cybersecurity problem

FDA issued a safety communication on January 9, 2017, detailing St. Jude Medical products that could be vulnerable to cyber threats. These threats could result in rapid battery depletion or administration of inappropriate pacing or shocks—potentially lethal outcomes. FDA noted that there have been no reports of patient harm related to the cybersecurity risks. The news comes

FDA’s CDRH reveals guidance plans for FY2017

CDRH is setting its goals along with the rest of us for the new year. The agency has published and prioritized its intentions for FY2017, starting with a list of new documents it intends to release in FY2017 (A-list). It has also shared a B-list of previously-issued final guidances for which CDRH would like feedback,

How Atlas Vac Machine plans to gain on UDI

Atlas Vac Machine, a maker of medical tray and blister sealers, has added new features to its equipment to better aid medical device companies trying to keep up with FDA’s Unique Device Identification rules. Over the past year, the Cincinnati-based company has had its machines providing data logging of operator IDs and passwords, sign-ins, PW

Mobile medical carts could have battery fire problems

U.S. FDA is warning health providers that battery-powered mobile medical carts could be a fire hazard. The agency has received reports of explosions, fires, smoking and overheating related to the carts, FDA said in its Dec. 27 letter to healthcare professionals. From January 2013 to July 2016, FDA received a dozen reports, an agency spokesperson

Changing your medical device: 6 things you need to know

Medical device regulatory consultant Michael Drues has never liked the phrase “change management.” The words seem boring to him. “Not only does it not have to be boring, it is incredibly important—and can be exciting and dare I say fun,” says Drues, who is president of Vascular Sciences (Grafton, MA). Whether it involves a medical

FDA and ‘emerging signals’: what you need to know

FDA will start issuing early warnings about medical devices that may be causing adverse events, under a final guidance for industry and FDA staff released this week. The plan for the agency to publicly disclose emerging safety signals drew fire from industry groups earlier this year. AdvaMed, for example, said in its public comment to

Senate passes 21st Century Cures Act funding research and medicine

The Senate passed the 21st Century Cures Act on Dec. 7, in a 94 to 5 vote, leaving the $6.3 billion legislation for President Barack Obama to sign. “[We are] pleased that the president is intending to sign the bill,” said AdvaMed president and CEO Scott Whitaker. “Our view is it’s a great victory for

FDA issues draft guidance on the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

The U.S. Food and Drug Administration released a draft guidance document on the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. This draft guidance clarifies how the FDA determines that real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the evidentiary standards we use to make

FDA issues draft guidances for next-generation sequencing tests

The FDA has published draft guidances that would streamline submission and review of data supporting the clinical and analytical validity of NGS-based tests. They represent a significant step, working within FDA’s existing regulatory authority, toward the FDA’s long-term goal of establishing a dynamic and flexible regulatory approach for genomic tests. The FDA has incorporated insights

FDA’s Device Evaluation Program is underway

The Food and Drug Administration (FDA) has been working closely with Industry negotiators and other stakeholders for years to establish a National Evaluation System for medical devices. The goal of establishing such an infrastructure is to generate real world evidence to efficiently monitor the long-term safety and effectiveness of medical devices. In the FDA’s Center

Improvements at the FDA: The regulatory trend no one is talking about

As we readied our first issue covering the hottest trends in the medical device industry, I was lucky enough to sit down with Cohera Medical CEO Patrick Daly at our DeviceTalks Research Triangle event. Our chat brought to mind a trend we don’t hear much about but that’s certainly under way: The FDA’s vastly improved

How to respond to FDA inspection observations, including those you dispute

by Martin Browning, President, EduQuest, FDA expert investigator and rule-maker for 22 years Although FDA is strapped with limited resources and competing priorities, the agency continues to hammer regulated companies with FDA 483 inspection observations and Warning Letters. In 2014 alone, FDA conducted more than 38,000 inspections and issued 8,457 Form 483s—inspection observations that, in the