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Medical Devices

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).

May 30, 2018 | Daily News

The American Hospital Association strongly supports FDA’s draft Medical Device Safety Action Plan, but says the agency needs to act swiftly and should take additional steps to ensure devices are protected from cyber attacks.

May 29, 2018 | Daily News

CMS plans to restart a tweaked version of a home health demonstration that it stopped just over a year ago following concerns from beneficiary advocates as well as home health providers that said the demo found more paperwork errors than fraud.

May 29, 2018 | Daily News

FDA on Tuesday (May 29) opened a public docket to gather input on the benefits and risks to health associated with medical software functions excluded from the definition of a medical device in the 21st Century Cures Act.

May 25, 2018 | Daily News

The Congressional Budget Office estimates that a proposal in the president's fiscal 2019 budget to expand and reform competitive bidding for durable medical equipment would cost $1.3 billion over 10 years, a stark contrast to HHS’ estimate the plan would save $6.5 billion over the same time period.

May 22, 2018 | Daily News

A Senate Appropriations subcommittee on Tuesday (May 22) voted unanimously to send to the full committee a fiscal 2019 FDA funding bill that appears to give the agency $163 million more than its current level but still less than requested by the administration, coming after House appropriators also agreed to hike FDA spending.

May 22, 2018 | Daily News

Device industry lawyers say a rule proposed by FDA May 15 to revamp how the agency classifies combination products, while including some beneficial changes, doesn't fix fundamental problems that make the process frustrating for industry.