Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
The device also assists with optical visualization, endoscopic treatment and diagnosis, and has two balloons that create a stabilizing therapeutic zone inside the colon.
The agency received nearly 12,000 adverse event reports relating to Essure last year, the majority of which were submitted in the last quarter of the year. Read More
The FDA posted a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana. Read More
Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Read More
The recalled anchors were not implicated in any deaths and they do not pose any risk of embolization as they remained attached to the implant, the company said. Read More
Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Read More
The firm’s CAPA procedures and lack of written MDR procedures were among the nonconformities flagged on more than one occasion after FDA inspections. Read More
Device manufacture is a complicated business, but few areas are more rulebound than QMS. Many a devicemaker has come up short trying to stay abreast of the FDA’s QSR, ISO 13485:2016, and other ISOs while trying to comply with competence, training and awareness rules. View
CDRH Reorganized lays out all of the moving pieces and lets you know what to expect, how to take advantage of new opportunities and how to influence the direction of the new system. And you’ll hear it from one of the people most qualified to interpret the changes, former CDRH Associate Director of Policy Paul Gadiock. View
Device quality must be implemented and communicated to the FDA, on pain of warning letters or worse. The rules and procedures are technical, involving both FDA rules and ISO 13485:2016. But mastery can be accomplished in only 90 minute View
“Smart” medical devices offer juicy targets to mischief-makers, and the threat is a global one. From garden-variety hackers, to cyber-mercenaries, to nation-states bent on global chaos, devicemakers face uncharted regulatory and liability risks. View
The FDA’s final guidance on UDI (unique device identification) raises as many questions as it answers. With full compliance for Class I, II and unclassified devices looming, lawyers are hard at work parsing the FDA’s language. View
The device supply chain can include hundreds of companies and stretch around the globe. Maintaining quality is a herculean task, yet the FDA requires it of you — at the risk of Forms 483, warning letters or worse. View
Devicemakers face a market upheaval in the EU. A new set of rules — the Medical Device Regulation (MDR) — will soon supplant the longstanding Medical Device Directive, forever changing how you sell medical devices in EU nations. View
Device regulation is about to change in ways large and small, as the CDRH moves toward a total reorganization. After it’s complete, the principal medical device overseer is expected to take a total product life-cycle (TPLC) approach, whereby postmarket realizations are fed back into premarket data requirements. View
“Lean management” has come to the drug and device world, improving quality, ensuring compliance and boosting profits for those who adapt its ways to the production floor. If you’re not among them yet, then listen up. View
Devicemakers: The quality of your manufacturing is only as good as the quality of your measuring equipment. But you can spend a fortune on metering devices and still turn out shoddy products. It all depends on how well they’re calibrated. View
There’s a transformation going on in the clinical trials world. It’s called mobile health (“mHealth”), and it entails use of smartphones, sensors and wearables to monitor trial subjects in ways not previously possible. View
On Nov. 8, the FDA is expected to issue twin final guidances revamping the device change process and determining when a new 510(k) is required. We explain it all to you ... and outfit you with tools to comply. View