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Medical Devices

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.

November 08, 2018 | Daily News

Drug industry lawyers are calling for FDA to give more specific feedback during new product reviews to drug applicants, saying the agency’s current process leaves out crucial details and makes the process more frustrating and contentious than necessary.

November 07, 2018 | Daily News

The Advanced Medical Technology Association (AdvaMed) and the National Organization for Rare Disorders (NORD) are confident that the interests of their constituencies will be well represented despite the shift from a GOP-led to Democrat-led House, plus some changes in the Senate, after the midterm elections.

November 07, 2018 | Daily News

With a Democratic takeover of the House, the powerful Energy & Commerce Committee will experience leadership and priority shifts. A former congressional aide told Inside Health Policy that Democrats may use the opportunity to push the Creating and Restoring Access to Equivalent Samples (CREATES) Act, seek funding options for opioid-related initiatives, focus more on cosmetics legislation and revisit laboratory-developed test (LDT) legislation.

November 06, 2018 | Daily News

FDA on Tuesday (Nov. 6) released a new app that agency chief Scott Gottlieb hopes will enable developers to collect real-world data from patients on new medical products.

November 02, 2018 | Daily News

The Advanced Medical Technology Association (AdvaMed) is confident that the interests of the medical device industry will be well-represented no matter which party controls the House and the Senate after the midterm elections due to the industry's support from both parties.

November 01, 2018 | Daily News

CMS on Thursday (Nov. 1) finalized changes for the next round of competitive bidding for durable medical equipment, as well as reimbursement rates for suppliers once the current round of competitive bidding ends Dec. 31 until the next round kicks in.

November 01, 2018 | Daily News

HHS has rebranded its cybersecurity center to distinguish it in the department's efforts to defend the health care sector's information technology infrastructure, an HHS spokesperson told Inside Health Policy.

October 25, 2018 | Daily News

Medical device experts voiced their approval of FDA's recent draft guidance that lays out how device manufacturers should address cybersecurity in their premarket submissions.

October 24, 2018 | Daily News

CMS is working on a rule to streamline Medicare coverage of breakthrough medical technologies, according to the agency's most recent regulatory agenda, which was unveiled shortly after CMS Administrator Seema Verma complained about Medicare's inability to quickly cover devices.

October 24, 2018 | Daily News

A key House health care committee suggested Tuesday that Congress bolster efforts by federal regulators to get medical device makers and other industries to ferret out cybersecurity vulnerabilities by offering a liability shield for independent cybersecurity researchers when vulnerabilities are reported, and by helping to distinguish between hacking and good-faith efforts to discover security lags.

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