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US Regulatory Roundup, August 2019: Safety And Compliance Take A Front Seat

Executive Summary

Concerns about paclitaxel-coated balloons and stents, as well as recalls linked to two large device manufacturers, captured the attention of many of our online readers last month, as did compliance-focused features that offered tips and advice from US FDA officials. Here are August's 10 most popular US regulation and policy stories from Medtech Insight.

An early August update from the US Food and Drug Administration that says more long-term clinical trials are needed to investigate a possible mortality risk tied to paclitaxel-coated balloons and stents was of most interest to Medtech Insight's online readers last month.

Paclitaxel coatings have been the subject of ongoing FDA scrutiny since a meta-analysis of randomized trials found that peripheral arterial disease (PAD) patients who received devices coated with the drug posed a more than 50% greater risk of death within five years. The agency told physicians in March to avoid use of the drug-coated devices in most PAD patients.

The update, reported on in our No. 1 story from August, incorporates recommendations based on current FDA research and the conclusions of a June meeting of the agency's Circulatory Devices Advisory Panel. The update says the FDA will take additional steps to address safety signals based on the new information; specifically, the agency is working with firms to add language addressing the mortality risk to device labeling and clinical trial patient consent forms.

The paclitaxel-coated balloons and stents update from the FDA wasn't the only drug-device combination product news that garnered significant attention from readers last month. Our No. 6 story detailed how long-delayed changes to the agency's approach to postmarket safety reporting for combo products are finally set to come into effect in 2020. The agency released a 44-page final guidance document on the topic in late July.

Meanwhile, a pair of Compliance Corner stories captured the No. 2 and No. 7 positions on our top 10 list. In the first, FDA investigator and medical device expert Phil Pontikos explained how device-makers can avoid running afoul of the agency's rules and expectations for sterilization activities, while in the second, FDA Compliance Branch directors Gina Brackett and Melissa Michurski shined a light on the agency's use of regulatory meetings.

Also of high interest to readers in August was an in-depth profile of Amy Abernethy, the FDA's principal deputy commissioner. That landed at No. 4 on our list, while a separate story that detailed Abernethy's skepticism about the use of wearable technologies for clinical needs was the third most-popular article last month.

Safety was also on the minds of Medtech Insight readers. Our article on a high-risk class I recall of Edwards Lifesciences' Sapien 3 Ultra Heart Valve delivery system was No. 5 on our top stories list; the problematic device has been linked to 17 injuries and one death. And in our No. 9 story, the FDA notified the public about a recall of certain Abbott Ellipse implantable cardioverter defibrillators, which are prone to electrical shorting because of a manufacturing flaw.

Other articles of interest included an announcement of a white paper by the Medical Device Innovation Consortium (MDIC) that lists what information is needed to ensure that patients understand the risks and benefits of their treatments, and news that manufacturers will see significant user-fee increases in fiscal year 2020.

The 10 most popular US regulation and policy stories in August are listed in the table below.




FDA Announces More Actions On Drug-Coated Devices


Compliance Corner: FDA Investigator Sees These 4 Common Sterilization Problems When Inspecting Facilities


Top FDAer Skeptical Of Wearable Devices, Says Agency Is Working To Improve Standards And Technology


MTI Profile: US FDA's Second-In-Command Has Her Eye On A Tech-Forward Future


Class I Recall On Edwards Sapien 3 Ultra Valve System


Combination Product Reporting Rule Set For 2020 Enforcement


Compliance Corner: 2 FDA Compliance Branch Heads Talk Regulatory Meetings – And What You Can Expect


MDIC Weighs In On Best Way To Inform Patients Of Risks And Benefits


New Heartache For Abbott Implantable Cardiac Devices After Manufacturing Flaw Discovered


Medtech Firms To See Significant User Fee Increases In FY 2020






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