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Medical Devices

July 19, 2018 | Daily News

House Majority Leader Kevin McCarthy (R-CA) on Thursday revealed plans to bring a permanent repeal of the medical device tax, a two-year delay of the health insurance tax, a reversal of the ACA's ban on using tax-preferred accounts for over-the-counter medicine and tweaks to health savings accounts (HSAs) to the floor next week, but sources say he doesn't plan a vote on legislation that would delay the 40 percent tax on high-cost plans (known as the Cadillac tax) or mitigate the employer mandate at this time.

July 16, 2018 | Daily News

A bill that would repeal the Affordable Care Act's controversial 2.3 percent excise tax on medical devices was not among a slew of bills marked up last week by the House Ways & Means Committee, but the measure is expected to come up on the House floor sometime this month.

July 16, 2018 | Daily News

FDA Commissioner Scott Gottlieb called for the creation of a national resource to coordinate the development and use of real-world evidence (RWE) in medical product development and regulatory science in a recent FDA Voice blog post.

July 13, 2018 | Daily News

A lawyer familiar with Supreme Court nominee Brett Kavanaugh and his jurisprudence said the judge, should he be appointed to the high court, would avoid deferring automatically to FDA or other federal regulatory agencies on cases involving matters where Congress has not given clear instructions.

July 13, 2018 | Daily News

A lawyer familiar with Supreme Court nominee Brett Kavanaugh and his jurisprudence said the judge, should he be appointed to the high court, would avoid deferring automatically to FDA or other federal regulatory agencies on cases involving matters where Congress has not given clear instructions.

July 11, 2018 | Daily News

Medical equipment suppliers won’t have to bid for Medicare business next year as CMS hasn’t yet started the next round of bidding and existing contracts run out at the end of the year, according to a proposed rule CMS released Wednesday (July 11), and one agency official said CMS needs time to implement changes to the bidding program laid out in the rule.

July 06, 2018 | Daily News

Top FDA officials, including FDA Commissioner Scott Gottlieb, reaffirm the need for a new regulatory framework for software as a medical device (SaMD), which they hope will help ease the regulatory uncertainty surrounding such products, increase consumer confidence in the technology, help payers and investors understand the technology, and allow the agency to keep up with the fast pace of software development.

July 06, 2018 | Daily News

Industry lawyers say FDA's ambitious goal of reviewing quickly evolving software-based medical devices in potentially 10 days or less is easier said than done, and requires a cultural shift in the agency from a purely science-based mindset to a business and organizational one.

July 03, 2018 | Daily News

A major hospital group says FDA needs to step up and mandate cybersecurity for medical devices, a move intended to address risks related to legacy products that can't be updated or adequately patched as Congress considers steps to protect patients from cyber attacks.

June 29, 2018 | Daily News

Device industry groups continue to express their strong support for a bill, cosponsored by more than half of the House, that would repeal a controversial 2.3 percent excise tax for medical devices, and one technology company representative said she heard from House Majority Leader Kevin McCarthy (R-CA) that the bill will be brought to vote in July.

June 22, 2018 | Daily News

A representative of an independent device service organization called out other ISOs for servicing medical devices without proper equipment or training, a concern which FDA said in a report released last month did not have enough evidence to be considered a widespread public health risk.

June 18, 2018 | Daily News

Senators from both parties urged FDA Commissioner Scott Gottlieb to keep up the pressure on CMS to add medical device identifier information to Medicare claims forms, a change which FDA expressed support for in the Medical Device Safety Action Plan it released in April.

June 15, 2018 | Daily News

FDA's decision to adopt a hands-off approach on medical device servicing has refueled congressional interest in legislation to beef up federal oversight of the industry, a spokesperson for the House Energy and Commerce Committee told Inside Health Policy.

June 15, 2018 | Daily News

The Medical Imaging & Technology Alliance (MITA) is working with device industry stakeholders on a nationwide voluntary standard for the servicing of medical devices, coming as FDA advocates a hands-off regulatory approach toward servicers, a MITA policy expert told Inside Health Policy.

June 12, 2018 | Daily News

In a policy reversal, Medicare will let seniors use an FDA-approved mobile app to send results from continuous glucose monitors to their doctors, families and caregivers. James Scott, president and CEO of Applied Policy, said the change sets a positive precedent for Medicare coverage of remote patient-monitoring technologies.

June 11, 2018 | Daily News

House lawmakers introduced a draft hazard preparedness reauthorization bill that would enhance FDA’s emergency use authorities and direct the agency to work toward developing medical countermeasures with regard to cybersecurity threats.

June 07, 2018 | Daily News

Representatives of large medical device manufacturing companies discussed methods for reducing obstacles to financing and marketing new medical devices with HHS Secretary Alex Azar during a roundtable discussion Thursday (June 7), according to an HHS readout of the meeting.

June 05, 2018 | Daily News

In a move opposed by genetics professionals, FDA published a final order Friday (6/1) that put genetic health risk assessment systems on a list of Class II medical devices exempted from premarket notification 510(k) requirements, subject to certain limitations.

June 01, 2018 | Daily News

FDA's decision to take a hands-off approach toward medical device servicing has left servicers and device makers at odds: Servicers praise the move, but device manufacturers are upset and say Congress must now step in to require at least some minimal level of federal oversight.

May 30, 2018 | Daily News

FDA is offering special incentives in its quest for medical and digital health device developers to submit proposals for “novel solutions” for detecting, treating and preventing addiction and for addressing diversion and treating pain, the agency said in a press announcement Wednesday (May 30).

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