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Medical Devices

May 05, 2017 | Daily News

Stakeholders clashed over a bipartisan bill that would require third-party device servicers to register with FDA and submit adverse event reports, causing lawmakers to think twice about their idea of attaching the bill to FDA user fee reauthorization legislation.

May 03, 2017 | Daily News

Health care providers complain that device manufacturers treat cybersecurity as an “afterthought,” according to a draft HHS Health Care Industry Cybersecurity Task Force report sent to Capitol Hill Wednesday (May 3).

May 03, 2017 | Daily News

An HHS task force on cybersecurity argues laws and rules put in place to prevent fraud and abuse within the health care sector could be preventing cooperation on securing data and networks, and that lawmakers need to consider easing those requirements to encourage cybersecurity investments.

May 03, 2017 | Daily News

A HHS task force on cybersecurity sent its long-awaited report to Congress Wednesday (May 3), laying out six “imperatives” for policymakers in the executive and legislative branches for helping the healthcare industry protect sensitive patient data that is increasingly the target for cyber attacks.

May 01, 2017 | Daily News

Congressional leaders are pushing a tentative bipartisan fiscal 2017 funding agreement that would give FDA $39 million more than its fiscal 2016 enacted level.

May 01, 2017 | Daily News

The Senate health committee has tentatively scheduled a markup of FDA user fee legislation for May 10, a committee spokesperson told Inside Health Policy.

April 25, 2017 | Daily News

FDA Commissioner-nominee Scott Gottlieb said he is open to using new regulatory tools to demonstrate the agency's gold standard of safety and efficacy, and took a muted tone towards President Donald Trump's proposal to reopen FDA's negotiated user fee agreements and the administration's support for Right to Try legislation in his answers to more than 60 written questions from Senate health committee ranking Democrat Patty Murray (WA).

April 25, 2017 | Daily News

House Energy & Commerce health subcommittee Chair Michael Burgess (R-TX) signaled Tuesday he would seek to attach four bipartisan medical device bills to the FDA Reauthorization Act of 2017.

April 25, 2017 | Daily News

The issue of how to create a framework to address cybersecurity regulatory science gaps will be discussed at a public workshop next month held by FDA, National Science Foundation and Department of Homeland Security's Science and Technology Directorate, coming as FDA's device center pegs cybersecurity as one of its top 10 regulatory science gaps.

April 24, 2017 | Daily News

FDA's recent high-profile clearance of genetic health risk tests by 23andMe brought with it a first-ever requirement that a sponsor create an opt-in page on its website -- previewing what potentially could reappear as the agency looks to exempt other GHR tests from device pre-market reviews.

April 21, 2017 | Daily News

HHS' human research protections committee is considering pushing FDA to provide more clarity on its policies related to use of real-world data (RWD) to support medical device decisions, including when use of such data will be considered an FDA-regulated clinical investigation, according to a draft of recommended changes to FDA's guidance on use of real-world evidence (RWE) in regulatory decision-making, which was obtained by Inside Health Policy.

April 20, 2017 | Daily News

FDA admonished device manufacturer Abbott for failing to establish and maintain procedures for correcting cybersecurity risks in its Merlin@home transmitter -- which it knew about in 2014 -- and for problems with premature drained battery life in its implantable cardiac devices, and warned of possible enforcement action if the problems aren't fixed.

April 13, 2017 | Daily News

After FDA delayed its controversial intended use rule for a year, one industry attorney is proposing a new intended use framework that would restrict FDA to looking at how a medical device is labeled when determining its marketed intended use.

April 12, 2017 | Daily News

FDA has entered into a multi-year collaborative agreement with biotechnology company Emulate that will allow the agency to evaluate the potential uses of the company's Organs-on-Chips technology to monitor the simulated human organs' reactions to ingredients in food, cosmetic and supplement products.

April 10, 2017 | Daily News

Mobile health application developers may now need to look beyond FDA and the Federal Trade Commission and worry about requirements across the 50 states when advertising health claims after the New York attorney general last Thursday (March 23) announced settlements with three companies to correct allegedly misleading claims, an industry attorney tells Inside Health Policy.

April 07, 2017 | Daily News

FDA recently issued what appears to be the first Regenerative Medicine Advanced Therapy (RMAT) designation following the creation of the pathway by the 21st Century Cures law.

April 06, 2017 | Daily News

FDA approved Thursday (April 6) the first direct-to-consumer (DTC) test to screen individuals for genetic predispositions to certain medical conditions.

April 03, 2017 | Daily News

FDA plans to dissolve its regional food and drug director functions and set up six new positions in charge of commodity-based programs as part of a Program Alignment Initiative launched in 2013.

March 31, 2017 | Daily News

A bipartisan group of senators introduced legislation Friday (March 31) to require local CMS contractors publicly explain Medicare coverage decisions, make it easier to challenge those decisions and bar contractors from adopting each others' coverage policies without conducting their own evaluations.

March 31, 2017 | Daily News

Former FDA Commissioner Robert Califf says the Trump administration's proposed cuts to FDA would pose a danger to public health.