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Medical Devices

October 18, 2018 | Daily News

A device industry lawyer expressed guarded confidence in a draft guidance FDA released last month that aims to revamp the agency’s 510(k) third-party review program, where qualified organizations review 510(k) submissions for certain low-risk devices.

October 12, 2018 | Daily News

A bipartisan group of 32 senators is asking CMS to extend its proposal to apply higher pay rates for durable medical equipment suppliers in rural areas, and Alaska and Hawaii, to also include suppliers in all non-bid areas, and more than 130 House lawmakers also sent a letter to the agency Oct. 12 with a similar request.

October 11, 2018 | Daily News

The national drug and device lobbies this week weighed in on a Utah Supreme Court case that could determine whether FDA approval of a medical device shields the product's manufacturer from strict liability claims over alleged design defects.

October 11, 2018 | Daily News

FDA's move toward developing more product-specific guidances rather than establishing policy through citizen petition responses may cause delays in agency policy development and leave industry left with unanswered questions, especially in the combination products space, one industry representative argued at a recent conference.

October 10, 2018 | Daily News

Three Democratic senators wrote to top FDA officials Wednesday (Oct. 10) that they have “serious concerns” about the agency's emerging precertification program, where precertified software developers would not be subject to premarket review.

October 10, 2018 | Daily News

Industry lawyers say it is not clear whether Congress' expansion of the sunshine law's reporting requirements to include industry payments to health professionals beyond doctors will kick in in 2021 or 2022.

October 04, 2018 | Daily News

An array of stakeholders voiced their support for the cross-industry role laid out in a set of sweeping cybersecurity initiatives unveiled by FDA Commissioner Scott Gottlieb this week, including new cybersecurity information sharing agreements, a playbook for hospitals to prepare for cybersecurity breaches and plans for an updated agency guidance document.

October 04, 2018 | Daily News

A device industry lawyer said FDA's recent speedy clearance of two Apple medical devices designed to detect atrial fibrillation -- announced the same day as a major Apple product launch Sept. 12 -- is the first time the agency appears to have coordinated its review process with a company launch.

October 03, 2018 | Daily News

CMS on Wednesday (Oct. 3) unveiled several changes to the local coverage determination process, including a way to request such a determination, repurposed public meetings and a reconsideration process that is consistent with that used for national coverage determinations.

October 02, 2018 | Daily News

Medical device industry experts said that a draft guidance released by FDA last week aimed at expanding the use of a faster premarket review program could, if finalized, be particularly useful for software companies, and would help the agency achieve its goal of reducing its average 510(k) review times.

October 01, 2018 | Daily News

FDA Commissioner Scott Gottlieb announced three new initiatives aimed at increasing cybersecurity preparedness and information-sharing among medical device stakeholders, particularly among health care delivery organizations (HDOs) such as hospitals.

September 28, 2018 | Daily News

The medical device industry may soon have more opportunities to use a faster premarket review program, thanks to proposals included in a draft FDA guidance that would expand the agency’s special 510(k) pathway for reviewing changes in certain devices.

September 27, 2018 | Daily News

A provision expanding the sunshine law to require drug and medical device makers publicly disclose payments made to health care providers beyond doctors made it into the final version of an opioid bill unveiled by House and Senate negotiators on Tuesday (Sept. 25), despite opposition from the medical device lobby.

September 21, 2018 | Daily News

The Advanced Medical Technology Association (AdvaMed) President and CEO Scott Whitaker is upset the Senate tucked into its recently passed opioid bill a provision expanding the sunshine law to require that drug and medical device makers also publicly disclose payments made to nurse practitioners, physician assistants and midwives – not just doctors and hospitals – for promotional talks, consulting and other interactions.

September 21, 2018 | Daily News

The Advanced Medical Technology Association (AdvaMed), the American Hospital Association and American College of Cardiology are concerned that aspects of FDA's Medical Device Safety Action Plan – including a voluntary 510(k) program for moderate-risk devices and a required software bill of materials (SBOM) – could create more medical device safety issues than it would solve, according to comments the groups recently submitted to FDA's docket.

September 20, 2018 | Daily News

A White House budget official said that the administration is doing “a lot of work right now on medical device stuff that nobody knows about,” and that he hopes to see some of those ideas start coming from CMS in the next six months.

September 18, 2018 | Daily News

A federal Judge on Friday dismissed a suit against Kaiser Permanente that charged the issuer's decision to cover cochlear implants but not hearing aids violated the Affordable Care Act's 1557 non-discrimination provisions, which bars plans from discriminating on the base of race, disability, color, national origin, sex, or transgender status.

September 17, 2018 | Daily News

FDA’s recent proposal to establish “a collaborative community” of stakeholders to support the agency in its decision-making process for diagnostics regulation could also serve as “a compelling new paradigm” for the cancer research community, Commissioner Scott Gottlieb said at a Friends of Cancer Research event Thursday (Sept. 13).

September 12, 2018 | Daily News

The Advanced Medical Technology Association praised a Local Coverage Decision transparency bill that passed the House by voice vote Wednesday (Sept. 13), but the College of American Pathologists is urging the Senate to reinsert a key provision removed by Ways & Means and said the bill's appeals language was weakened prior to the House vote.

September 11, 2018 | Daily News

A device industry lawyer said a draft guidance FDA issued Sept. 5 shows the agency is willing to accept greater premarket risk in the device development process, as long as postmarket controls and data collection procedures are in place.