Regulatory and Compliance

421 Regulatory and Compliance Articles
Posted in Regulatory and Compliance by amanda.pedersen on August 10, 2017
FDA is keeping tabs on two liquid-filled intragastric balloon systems used to treat obesity because at least five patients have died within a month of having the insertion procedure.Amanda PedersenReShape Medical's Integrated Dual Balloon System, approved by FDA in 2015, is one of two balloon-based ... Continue
The 21st Century Cures Act paved the way for deregulation of a host of medical devices ranging from surgical lights to dentures.Kristopher SturgisFDA announced this week a list of more than 1,000 medical devices that will now be exempt from 510(k) notification requirements — a move that aims ... Continue
Posted in Regulatory and Compliance by Jamie Hartford on July 5, 2017
Follow these best practices to get the most out of your next design review.Jamie HartfordDesign reviews are an important element laid out in FDA’s design control guidance for medical device manufacturers. The agency requires device makers to establish and maintain documented reviews of their desig... Continue
Posted in Regulatory and Compliance by Daphne.Allen on May 31, 2017
If you're developing a medical device that will be reprocessed, you've got a lot to consider.Daphne AllenAlpa Patel, B.S. RM (NRCM)Developing a cleaning validation for a reusable medical device presents several challenges. How are you addressing them?“There have been many issues over the last 7 ye... Continue
Posted in Regulatory and Compliance by amanda.pedersen on May 18, 2017
Endologix now needs to conduct a confirmatory clinical trial for its Nellix endovascular aneurysm sealing system, pushing the projected FDA approval to at least 2020. Endologix’s Nellix EndoVascular Aneurysm Sealing (EVAS) system was one of the most hotly anticipated medical devices of 2016, ... Continue
Posted in Regulatory and Compliance by amanda.pedersen on May 18, 2017
The company has a new management team in place, including a chief compliance officer, to fix quality control problems related to the EndoBarrier device.Amanda PedersenGI Dynamics has faced multiple regulatory setbacks with its EndoBarrier device, which is intended to treat obese patients with Type 2... Continue
Posted in Regulatory and Compliance by MarieThibault on May 17, 2017
A years-long initiative to add unique device identifiers to insurance claims forms continues, with supporters asking the new directors of CMS and FDA to rally behind the cause.Marie ThibaultA group of healthcare systems, payers, medical societies, and medical product companies have asked the new lea... Continue
Posted in Regulatory and Compliance by Nancy Crotti on May 15, 2017
Cook Medical’s Flourish device uses magnets to pull the upper and lower esophagus together, allowing food to reach the stomach.Nancy Crotti Cook Medical's Flourish pediatric esophageal atresia device is used to non-surgically repair the esophagus in infants who were born with their upper esop... Continue
Posted in Regulatory and Compliance by Daphne.Allen on April 10, 2017
Enterprise labeling systems can help medical device manufacturers manage data in some surprising ways. Enterprise labeling software solutions have been helping medical device manufacturers manage label design, printing, and more for years. But in today’s data-rich environment thanks to Unique Devi... Continue
Posted in Regulatory and Compliance by amanda.pedersen on March 29, 2017
Risk management strategy should be about more than a series of checkboxes on a regulatory form. Consultant Mike Drues encourages his clients to think outside the checkboxes to create a risk management plan that makes sense from an engineering and biology perspective.Amanda Pedersen All medical ... Continue
Posted in Regulatory and Compliance by Daphne.Allen on March 23, 2017
A new solution allows users to track compliance pertaining to events and corrective actions using either mobile devices or via Web browsers. Daphne AllenManaging corrective actions is one of medtech companies’ most complex tasks. Many companies, however, continue to use simple solutions like ... Continue
Posted in Regulatory and Compliance by Nancy Crotti on March 9, 2017
The Tryton side-branch stent is compatible with stents manufactured to treat lesions in the main coronary artery, according to its North Carolina manufacturer.Nancy CrottiTryton Medical's side-branch stent is designed to treat, protect, and secure bifurcation lesions and integrates into any conventi... Continue
Posted in Regulatory and Compliance by amanda.pedersen on March 8, 2017
FDA issued a warning to patients and physicians against an experimental procedure called transvascular autonomic modulation (TVAM) using balloon angioplasty devices. The agency said TVAM puts patients at risk for several reasons.Amanda Pedersen Patients and doctors considering an experimental p... Continue
Posted in Regulatory and Compliance by amanda.pedersen on February 13, 2017
FDA warns Rapid Release Technologies that its therapeutic vibrator, which has not gone through the agency’s regulatory approval process, is considered a medical device based on its intended uses. The company said it is working with FDA and consultants to comply with FDA labeling requirements. ... Continue
Posted in Regulatory and Compliance by Nancy Crotti on January 19, 2017
The device could represent the first major change in expansion procedures in 40 years.Nancy CrottiFDA has granted de novo clearance to the first breast-tissue expander that uses air instead of saline and shortens the process from mastectomy to reconstruction.AirXpanders of Palo Alto, CA, recently co... Continue
Posted in Regulatory and Compliance by amanda.pedersen on December 21, 2016
FDA approval of Dexcom’s dosing claim is seen as a major stride in the journey to eliminate finger pricks for good in diabetes management.Amanda PedersenDexcom's G5 is the first FDA-approved continuous glucose monitoring device to win dosing claim, allowing patients to rely on the CGM re... Continue
Posted in Regulatory and Compliance by amanda.pedersen on December 15, 2016
FDA hit Zimmer Biomet with a 57-page Form 483 that one analyst called “one of the longest and most serious” a consultant for his firm had ever seen. Amanda PedersenJust as Zimmer Biomet Holdings was returning most of its product lines to full capacity after unexpected shipping delays in the... Continue
Posted in Regulatory and Compliance by Jamie Hartford on December 14, 2016
How is CDRH doing when it comes to decision times, approval rates, and more?Jamie HartfordLast week, FDA released a report on its quarterly progress toward meeting the performance objectives set out in the Medical Device User Fee Ammendments of 2012 (MDUFA III). The report includes updates on P... Continue
Posted in Regulatory and Compliance by Nancy Crotti on December 13, 2016
The Class I recall is just the latest in a series of catheter recalls for U.S. companies.Nancy CrottiA Michigan company is recalling certain single-lumen catheters due to the potential for excess material to separate from the catheter and enter a patient’s bloodstream.Don't miss the MD&M West ... Continue
Posted in Regulatory and Compliance by MarieThibault on December 6, 2016
Medtronic announces its Endurant II/IIs Stent Graft System has earned CE Mark for an expanded indication. The regulatory win gives abdominal aortic aneurysm patients with short aortic necks an "off-the-shelf" option for endovascular aneurysm repair.Marie ThibaultPatients who have abdominal aort... Continue