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Medical Devices

Tuesday, 25 April 2017

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).

Tuesday, 25 April 2017

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.

Tuesday, 25 April 2017

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.

Monday, 24 April 2017

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.

Friday, 21 April 2017

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.

Thursday, 20 April 2017

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.

Thursday, 13 April 2017

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.

Wednesday, 12 April 2017

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.

Monday, 10 April 2017

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.

Friday, 07 April 2017

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.

Thursday, 06 April 2017

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

Monday, 03 April 2017

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.

Friday, 31 March 2017

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.

Friday, 31 March 2017

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

Tuesday, 28 March 2017

Lawmakers and stakeholders highlighted the successes of the medical device user fee program in speeding up FDA's review of devices, during a Tuesday (March 28) House Energy & Commerce hearing on reauthorization of the Medical Device User Fee Amendments (MDUFA).

Tuesday, 28 March 2017

The Trump administration is proposing a $40 million cut in FDA appropriations for the remainder of fiscal 2017, driven primarily by reductions in staffing, according to a document obtained by Inside Washington Publishers, which was recently sent to congressional appropriators.

Tuesday, 28 March 2017

A House Energy & Commerce Republican is pushing legislation that would give drug and device makers more leeway to discuss off-label information with the scientific community by exempting scientific exchange from intended use determinations, coming after FDA delayed for a year an intended use rule finalized in the last days of the Obama administration.

Tuesday, 21 March 2017

Recent calls from the medical device industry for Congress to push a risk-based framework for regulating laboratory developed tests (LDTs) appear to be answered by a new bipartisan draft bill that would give FDA authority over design, development, validation and production of in-vitro clinical tests (IVCTs), including LDTs, while retaining CMS' jurisdiction over laboratory operations.

Tuesday, 21 March 2017

A week after the president took stakeholders by surprise by proposing industry fully pay for FDA premarket reviews by doubling up on user fees, the White House plan was barely mentioned as Senate health committee Chairman Lamar Alexander (R-TN) launched hearings Tuesday (March 21) on user fee pacts penned by the Obama administration and industry.

Friday, 17 March 2017

FDA has put on hold until next March a controversial tobacco “intended use” rule that sparked controversy due to a last-minute addition that industry said posed extensive liability issues for drug and device manufacturers.