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Medical Devices

April 19, 2019 | Daily News

As part of a broader effort to reconsider its regulation of implantable medical devices, FDA on Thursday (April 18) announced the release of a draft guidance detailing the types of information manufacturers should include in premarket submissions for devices containing nitinol, an alloy of nickel and titanium.

April 18, 2019 | Daily News

FDA has ordered surgical mesh for transvaginal repair of pelvic organ prolapse (POP) manufacturers Boston Scientific and Coloplast to stop selling and distributing the products, the agency announced Tuesday (April 16).

April 12, 2019 | Daily News

Sources say a memo by the White House Office of Management and Budget that requires federal agencies submit non-binding guidance to the Office of Information and Regulatory Affairs -- and potentially to Congress -- could throw a wrench in FDA’s usual guidance-making process, which could negatively affect both the agency and industry.

April 12, 2019 | Daily News

New findings from duodenoscope sampling studies show the number of high-concern organisms found on reprocessed duodenoscopes is nearly 2.5% more than what FDA originally reported back in 2018, the agency’s device center director announced Friday (April 12).

April 11, 2019 | Daily News

Device stakeholders have another 30 days to comment on FDA’s proposal to post on its website cleared devices that demonstrated substantial equivalence to older predicate devices as part of its bid to encourage device makers to use new predicates.

April 09, 2019 | Daily News

The new chairman of the Advanced Medical Technology Association’s (AdvaMed’s) board of directors, Kevin Lobo, says the most pressing issue facing the industry is the Affordable Care Act’s 2.3 percent excise tax on medical devices, the latest moratorium on which ends next year.

April 08, 2019 | Daily News

Since his early March announcement that he would be leaving FDA, former agency commissioner Scott Gottlieb ramped up work to wrap up, or initiate, myriad goals he wanted to accomplish during his time with the agency.

April 02, 2019 | Daily News

In a white paper released Tuesday (April 2), FDA details an oversight process that outgoing agency commissioner Scott Gottlieb said could allow artificial intelligence-based medical devices to iterate autonomously while still letting FDA provide a reasonable assurance of safety and effectiveness.

March 28, 2019 | Daily News

American Clinical Laboratory Association (ACLA) president and CEO Julie Khani said she looks forward to starting a dialogue with FDA to refine aspects of a draft bill that would redefine the agency’s regulatory authority over diagnostics.

March 28, 2019 | Daily News

FDA is proposing to amend its regulatory framework for mammograms and mammography facilities, which would include for the first time a federal requirement that breast density information be included in communications to patients and health care providers, the agency announced Wednesday (March 27).

March 28, 2019 | Daily News

FDA Commissioner Scott Gottlieb says his agency is looking into less environmentally hazardous methods of medical device sterilization after the Illinois Environmental Protection Agency ordered a large sterilization facility to close in February due to ethylene oxide emissions.

March 21, 2019 | Daily News

Durable medical equipment lobbyists took their fight against adding ventilators to the competitive bidding program to the White House Domestic Policy Council after vowing to pressure the administration and Congress to change the policy.

March 20, 2019 | Daily News

FDA Commissioner Scott Gottlieb said he will testify before Congress in support of FDA’s 2020 budget on April 3, before leaving the agency two days later.

March 19, 2019 | Daily News

FDA is launching a broad effort to revisit implantable device regulation in light of a growing body of data that shows material in some devices could harm certain patients, according to outgoing agency chief Scott Gottlieb and device center head Jeff Shuren.

March 19, 2019 | Daily News

Medical device industry lobby groups are asking FDA to make major changes to the draft premarket cybersecurity guidance it released in October, questioning the agency’s proposed two-tier risk system, Cybersecurity Bill of Materials and one-size-fits-all approach.

March 18, 2019 | Daily News

Several medical device industry lawyers say FDA guidance that outlines how companies can seek feedback on actions they propose to correct problems found during inspections puts industry in a quandary.

March 13, 2019 | Daily News

FDA’s device center announced on Wednesday (March 13) that it will launch its long-planned internal reorganization aimed at addressing the total life cycle of products on March 18 and, should all go as planned, complete the overhaul by Sept. 30, 2019.

March 13, 2019 | Daily News

As speculation of who could be confirmed to permanently replace FDA Commissioner Scott Gottlieb circulates among the media and stakeholders, consumer advocates say they would prefer someone who has fewer ties to industry while one industry consultant hopes the next commissioner will be an outsider who has familiarity with data and technology yet can still work within the guardrails of FDA.

March 12, 2019 | Daily News

CMS’ decision to add non-invasive ventilators to the revamped durable medical equipment competitive bidding program set to go into effect in 2021 has upset DME suppliers, with the DME lobby calling it a “terrifying development” for patients and saying the group will press the Trump administration and Congress to stop that addition.

March 12, 2019 | Daily News

National Cancer Institute Director Ned Sharples will become acting commissioner of FDA when current Commissioner Scott Gottlieb resigns in early April, HHS Secretary Alex Azar announced at a House hearing Tuesday (March 12).

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