Policy & Regulation: Page 2
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FDA's De Novo pathway is about to get a makeover
"Particularly with really low risk devices, it can be challenging both from FDA's perspective and industry's perspective in terms of how much data is needed," Allyson Mullen, an attorney at Hyman, Phelps & McNamara told MedTech Dive.
By Meg Bryant • Dec. 03, 2018
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UK and EU inch toward regulatory cooperation after Brexit
As the leave date looms next March, a political declaration notes the bloc will explore the possibility of cooperation by U.K. authorities with agencies like the European Medicines Agency.
By Suzanne Elvidge • Dec. 03, 2018
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FDA offers more study options for CLIA waivers in redrafted guidances
The agency added new test design alternatives for manufacturers seeking waivers for IVD devices, a nod to a push from AdvaMed and others.
By Maria Rachal • Nov. 30, 2018
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FDA issues draft guidance on blood glucose monitors
The agency said distinguishing between test systems used in healthcare settings and those for use by patients at home will improve product safety and effectiveness of the devices.
By Susan Kelly • Nov. 30, 2018
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Canada vows to strengthen device regulation following media probe
More stringent approval requirements and the mandatory publication of clinical data are among the changes being discussed.
By Nick Paul Taylor • Nov. 30, 2018
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HHS outlines broad plan to reduce EHR burden
The 74-page draft strategy, required by the 21st Century Cures Act, focuses on reducing time and effort tied to regulatory reporting requirements and increasing functionality and user-friendliness of EHRs.
By Meg Bryant • Nov. 29, 2018
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Deep DiveWhy political contributions linked to a little-known hearing aid firm topped medtech giants
Spending connected to Starkey Hearing Technologies surpassed Medtronic, Boston Scientific and Edwards Lifesciences during the 2018 election cycle.
By David Lim • Nov. 29, 2018
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5 takeaways amid new scrutiny of FDA medical device oversight
A slate of recent agency actions have paralleled a new investigative series on product safety by the International Consortium of Investigative Journalists. Here are five areas that could be impacted.
By David Lim • Nov. 27, 2018
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FDA approves autoinjector version of Genentech's Actemra
The Roche unit is pitching the device as a convenient self-administration option for some users of its blockbuster drug.
By Nick Paul Taylor • Nov. 27, 2018
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FDA pitches boosting 510(k) scrutiny, asks Congress for help
The agency wants to move away from device maker reliance on 510(k) predicate devices older than 10 years and gain new authority to quickly impose special controls.
By David Lim • Nov. 26, 2018
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Beckman initiates Class I recall of flow cytometers
FDA is concerned inaccurate results provided by the devices could lead to serious injuries or deaths.
By Nick Paul Taylor • Nov. 22, 2018
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FDA device inspections hit high amid overseas oversight push
The agency conducted 2,952 inspections of medical device manufacturers last year, an increase of 46% over 2007.
By Nick Paul Taylor • Nov. 22, 2018
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ECRI launches clinical guidelines site to replace resource HHS shuttered
The new portal will include "expertly vetted, evidence-based guideline briefs and scorecards" for the healthcare community, according to the Pennsylvania-based nonprofit group.
By Rebecca Pifer • Nov. 21, 2018
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FDA details ramp-up of postmarket device oversight
The agency laid out plans to increase postmarket surveillance of medical devices and previewed details coming next week on how it expects to modernize premarket reviews, especially the 510(k) process.
By Susan Kelly • Nov. 21, 2018
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Telehealth laws inhibit widespread use in Medicare population, CMS says
The agency is taking steps to open up virtual care options in some alternative payment models, but use among fee-for-service beneficiaries is only 0.25%, according to a new report.
By Meg Bryant • Nov. 19, 2018
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Abbott seeks clearer security standards as feds increase cyber risk focus
President Trump is expected to sign legislation Friday creating a new cyber agency within the Department of Homeland Security.
By Maria Rachal • Nov. 16, 2018
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CMS' Verma outlines vision for connected digital health network
The agency also submitted a report to Congress on the state of Medicare telehealth, outlining how beneficiaries are currently using remote care and how CMS is looking to further expand similar services to rural areas.
By Nick Paul Taylor • Nov. 16, 2018
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House chairman sees 'every indication' that VA's EHR difficulties will continue
"Frankly," Indiana Rep. Jim Banks said, "the more I learn about the EHR program, the more daunting it has become."
By Tony Abraham • Nov. 15, 2018
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AdvaMed makes lame duck push for medical device tax repeal
Given the impending Democratic control of the House, the trade group's CEO Scott Whitaker said "the chances are not as great next year" for permanent repeal if the industry does not garner a victory.
By David Lim • Nov. 15, 2018
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FDA sounds alarm about off-label drug use in pain pumps
The agency wants physicians to stick to approved drugs to reduce the risk of device failure in the pumps, which include those sold by Medtronic and J&J.
By Nick Paul Taylor • Nov. 15, 2018
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US Vascular gets FDA warning letter for long-running problems
Most of the points raised in the regulatory notice date back to a 2016 inspection.
By Nick Paul Taylor • Nov. 15, 2018
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FDA plans to waive informed consent for some clinical trials
The change would enable sponsors to run certain minimal-risk studies without gaining consent from participants.
By Nick Paul Taylor • Nov. 14, 2018
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Medtronic gets CE mark for low-profile thoracic endograft
The clearance comes weeks after FDA approved the Valiant Navion TEVAR endograft.
By Nick Paul Taylor • Nov. 14, 2018
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It's final: Amazon pegs NY, Virginia for HQ2 (with a nod to Nashville)
Amazon will split its new North American headquarters over two sites. The city of Nashville is also a surprise winner, landing 5,000 jobs as part of an "operations center of excellence," the company said Tuesday.
By Samantha Liss • Nov. 13, 2018
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Grassley questions FDA about 'troubling' cybersecurity audit
"Medical devices could be exploited by those same foreign actors to not only interfere with normal device operation, which could cause harm to patients, but also to steal personal medical information," the senator wrote.
By Nick Paul Taylor • Nov. 13, 2018