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Medical Devices

June 21, 2021 | Daily News

FDA is taking steps to address key medical device servicing issues, including by publishing a highly anticipated remanufacturing draft guidance that aims to draw a clear line between medical device servicing and remanufacturing activities and ensure original device manufacturers and third-party device servicers adhere to agency standards for fixing and updating medical devices.

June 18, 2021 | Daily News

Members of the GOP Doctors Caucus want FDA to prioritize reviewing applications for tests that measure the presence of T-cell immunity to COVID-19, rather than focusing only on reviewing and authorizing applications for rapid diagnostics, point-of-care tests and variant diagnostics.

June 16, 2021 | Daily News

Sen. Tim Scott (R-SC) reportedly plans to introduce a bill Wednesday (June 16) that aims to bring medical product manufacturing to the United States and prevent shortages by providing a tax incentive for products made in certain U.S. areas and creating a new approval pathway for advanced manufacturing technologies.

June 15, 2021 | Daily News

FDA’s Spring 2021 regulatory agenda indicates the agency could release as soon as this month its long-awaited proposed rule to establish an over-the-counter category of hearing aids and lay out safety, labeling and manufacturing standards for the devices, coming as key lawmakers press HHS to get the regulation out.

June 14, 2021 | Daily News

FDA will move forward with finalizing a controversial rule that aims to clarify what kind of evidence the agency will consider when determining a product’s intended use, the agency reveals in its Spring 2021 regulatory agenda published Friday (June 11).

June 04, 2021 | Daily News

FDA officials say manufacturers of COVID-19 tests that are on the market under emergency use authorization should begin submitting applications to convert their EUAs to full approval so they can stay on the market after the COVID-19 public health emergency is over.

May 28, 2021 | Daily News

In its fiscal 2022 budget justification released Friday (May 28), FDA identifies several legislative proposals it says could help with the agency’s COVID-19 pandemic response, including by giving FDA authority to require specific medical device supply chain information, request facility records in advance or in lieu of inspections, and share medical product information with state and local governments.

May 27, 2021 | Daily News

The White House is reviewing an FDA draft guidance that device makers hope will lay out strict requirements for third-party device servicers.

May 26, 2021 | Daily News

FDA on Wednesday (May 26) published two new draft guidances that detail the agency’s thoughts and recommendations for how sponsors should conduct post-approval studies for and continuous postmarket surveillance of agency-approved medical devices.

May 24, 2021 | Daily News

Food and drug law experts are closely watching a number of court cases in 2021, including one at the Supreme Court that involves consolidation of product liability lawsuits and could have implications for how courts handle case backlogs after COVID-19.

May 24, 2021 | Daily News

One of the largest clinical laboratory groups in the United States on Friday (May 21) asked the Biden administration to prevent FDA from overseeing laboratory-developed diagnostic tests, coming as key House Democrats press Biden’s HHS to go in the other direction and restore FDA’s lab test oversight that was taken away by a controversial Trump-era directive.

May 20, 2021 | Daily News

FDA has pushed back by another two years the deadline by which medical device manufacturers must switch over to using unique device identifiers, rather than legacy National Health Related Item Codes and National Drug Codes, on device labels and packaging.

May 13, 2021 | Daily News

The Federal Trade Commission published a report Tuesday (May 11) calling for right-to-repair laws based on what it says is a lack of evidence supporting original manufacturers’ justifications for repair restrictions, though the agency says it is unlikely a one-size-fits-all approach could encompass both medical devices and consumer products.

May 11, 2021 | Daily News

Democratic leaders of the House Energy & Commerce Committee on Tuesday pressed HHS Secretary Xavier Becerra to restore FDA’s premarket regulation of laboratory-developed tests by scrapping a Trump-era policy that revoked the agency’s jurisdiction.

May 11, 2021 | Daily News

FDA reveals in an inspection roadmap that, in the best-case scenario, the agency likely will only be able to complete 27% of the 15,514 domestic inspections it would need to conduct this year to catch up from the surveillance lag caused by the COVID-19 pandemic.

April 30, 2021 | Daily News

FDA on Friday (April 30) revoked emergency use authorization for Battelle’s respirator decontamination system after the company requested voluntary withdrawal of the EUA.

April 29, 2021 | Daily News

FDA plans to issue recommendations for how diagnostics developers can seek emergency use authorization for dual-purpose COVID-19 tests that can both diagnose the disease and report to patients whether the strain detected is a variant, Timothy Stenzel, director of FDA’s office of in vitro diagnostic and radiological health, said during a Wednesday (April 28) stakeholder call.

April 28, 2021 | Daily News

Pew Charitable Trusts is urging HHS to walk back its previous decision under the Trump administration to strip FDA of its ability to regulate of laboratory-developed tests before they hit the market, saying the policy elimination is “short-sighted” and hinders FDA’s ability to protect patients.

April 21, 2021 | Daily News

Medical device manufacturers and FDA are at odds over how to use $200 million in revenue left over from the current round of medical device user fees.

April 20, 2021 | Daily News

FDA announced Tuesday (April 20) that it will allow certain authorized COVID-19 diagnostic tests to be used to test large groups of asymptomatic people for SARS-CoV-2 on a regular basis, as long as developers can self-certify that they have validated the tests for pooling.

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