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Medical Devices

December 19, 2018 | Daily News

Four device industry lawyers said the de novo rule proposed by FDA Dec. 4 could discourage product developers from entering the de novo pathway by making the route resemble the beefier premarket approval (PMA) process, which is typically reserved for higher-risk devices.

December 18, 2018 | Daily News

FDA announced two actions Tuesday (Dec. 18) aimed at encouraging industry to take advantage of two accelerated review and development pathways for new devices.

December 18, 2018 | Daily News

A medical device industry lawyer said a recent report issued by FDA on digital health tools reassures stakeholders that the agency will not regulate five categories of software which Congress deemed safe when it passed the 21st Century Cures Act in 2016.

December 13, 2018 | Daily News

A medical device industry lawyer says a newly unveiled FDA final rule on medical device classification and reclassification improves on the 2014 proposed rule, and it could indicate the agency intends to reclassify more devices as it moves to update its 510(k) process.

December 10, 2018 | Daily News

FDA issued the interim results of agency-mandated duodenoscope reprocessing studies to help inform hospitals and health care facilities of the need to carefully clean and properly maintain the devices, the agency said Monday (Dec. 10).

December 07, 2018 | Daily News

Industry lawyers expect more in vitro diagnostic test makers to apply for CLIA waivers thanks to newly issued FDA guidances that make the process less prescriptive and clarify that tests for which trained and untrained users get comparable results are entitled to a waiver.

December 06, 2018 | Daily News

In a surprise move Thursday (Dec. 6), bipartisan duos of House and Senate lawmakers released draft legislation that lays out a framework for FDA to regulate in vitro clinical tests, such as test kits and laboratory developed tests (LDTs).

December 05, 2018 | Daily News

A device and diagnostics lawyer says FDA’s formal recognition of a public database of information about genes, genetic variants and their relationship to disease could help new genetic tests reach market.

December 04, 2018 | Daily News

A medical device industry expert told Inside Health Policy he expects a new proposed rule published by FDA on the de novo pathway will go a long way towards clarifying the process for device manufacturers, helping FDA reach the performance goals laid out by Congress and helping the agency achieve its goals of modernizing the 510(k) premarket notification process.

November 30, 2018 | Daily News

After six months and over 250 applications, FDA finally announced the eight winners of an innovation challenge in which medical device developers submitted to the agency their best ideas for preventing and treating opioid addiction.

November 29, 2018 | Daily News

A device industry lawyer alleges that FDA’s proposals to reform its 510(k) process violates the agency’s statutory authority, threatens to monkey around with the device market, and would increase the cost of device innovation and health care more generally.

November 29, 2018 | Daily News

A medical device expert and former FDA staffer says that the Medical Device Enforcement and Quality Report released by FDA on Nov. 21 appears intended to dispel criticism that the agency does not take sufficient enforcement action when appropriate while also appealing to Congress for help with funding for device-related postmarket activities.

November 28, 2018 | Daily News

A day after releasing a plan to overhaul FDA’s clearance process for certain low- and moderate-risk medical devices, FDA Commissioner Scott Gottlieb defended his agency’s proposals amidst a wave of industry opposition to them and used cybsecurity concerns to make his point.

November 26, 2018 | Daily News

Device industry leaders were taken aback that FDA is considering publishing online the names of devices cleared using predicate devices that are 10 years old or older -- a move the agency announced Monday (Nov. 26) as part of a broader effort to modernize and tighten its medical device clearance process amid recent reports of safety issues.

November 21, 2018 | Daily News

One industry lawyer found that FDA has put out many more new rules for the food and medical device industries over the past six years than it has for other industries, such as drugs, biologics, cosmetics and animal feed.

November 20, 2018 | Daily News

FDA Commissioner Scott Gottlieb on Monday (Nov. 19) introduced a new risk-based framework for how the agency will regulate software products that are designed to be used in conjunction with prescription drugs, also known as prescription drug-use-related software.

November 20, 2018 | Daily News

FDA device center chief Jeff Shuren says that his agency, in order to consistently be the best in the world at identifying and responding to device safety signals, will need more resources to fuel its real-world evidence-gathering apparatus, the National Evaluation System for health Technology (NEST) and its coordinating center (NESTcc).

November 15, 2018 | Daily News

Scott Whitaker, the president and CEO of Advanced Medical Technology Association (AdvaMed), said he is confident there are enough Senate votes to pass a medical device tax repeal bill before the end of this session of Congress, so long as lawmakers find a legislative vehicle.

November 15, 2018 | Daily News

FDA on Tuesday (Nov. 13) moved toward fulfilling provisions in the 21st Century Cures Act that allow FDA to waive or alter informed consent regulations for minimal risk clinical investigations as long as there are appropriate human subject protections in place.

November 08, 2018 | Daily News

FDA and the HHS Office of Inspector General are butting heads over whether the agency is equipped to address postmarket cybersecurity risks to medical devices.

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