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Medical Devices

March 24, 2020 | Daily News

A draft Senate COVID-19 stimulus compromise floated Tuesday (March 24) maintains multiple provisions that would expand requirements for drug makers to report product shortages, give FDA authority to require device makers report shortages and potential supply disruptions, and protect manufacturers of respiratory masks from lawsuits.

March 24, 2020 | Daily News

In light of the COVID-19 pandemic, FDA says it will not take enforcement action against certain companies that do not submit adverse event reports to the agency within the standard required timeframe.

March 23, 2020 | Daily News

FDA on Monday (March 23) announced new procedures that will allow the agency to issue COVID-19-related guidance documents as fast as possible.

March 23, 2020 | Daily News

Republicans on the House Energy & Commerce Committee are pushing for the bipartisan Safeguarding Therapeutics Act (H.R. 5663) to be included in the COVID-19 response legislative package moving through Congress.

March 22, 2020 | Daily News

Senate Republicans attempted to remove language that would exempt drug shortage reports from Freedom of Information Act (FOIA) disclosures while adding in confidentiality language in their phase three COVID-19 package unveiled Sunday (March 22).

March 22, 2020 | Daily News

Senate Republicans continue to push for liability protections for mask manufacturers in their latest stimulus package, which includes a provision that would protect from lawsuits the manufacturer of any respiratory protective device that’s approved by the National Institute for Occupational Safety and Health and deemed a medical countermeasure by HHS.

March 20, 2020 | Daily News

The American Clinical Laboratory Association is pressing Congress to provide surge capacity funding and other resources to labs conducting COVID-19 testing. In a letter sent to Senate and House leaders Thursday (March 19), ACLA calls for $5 billion for labs, and requests Congress clarify that labs can qualify for loans and other resources under the Defense Production Act.

March 19, 2020 | Daily News

Medical device makers would be required to report potential device shortages or supply disruptions to FDA should Congress pass the Senate’s latest coronavirus stimulus bill, which also includes expanded drug shortage reporting requirements for drug makers.

March 19, 2020 | Daily News

FDA has postponed all routine domestic facility inspections in order to protect the health and well-being of agency staff and to address industry’s concern over visitors, FDA announced Wednesday (March 18), coming as the Trump administration advises against unnecessary travel due to the nationwide spread of COVID-19.

March 19, 2020 | Daily News

FDA issued a guidance on Wednesday (March 18) offering flexibility around clinical trial policies in a bid to maintain patient safety and test integrity amid the challenges posed by the COVID-19 pandemic, including the possibility of virtual and phone visits for trial participants.

March 13, 2020 | Daily News

The Trump administration took new steps Friday (March 13) to speed up coronavirus testing: HHS Secretary Alex Azar tapped former acting FDA chief Brett Giroir to coordinate diagnostic testing efforts by the Centers for Disease Control and Prevention (CDC), FDA and public and private laboratories across the country; and FDA decided to let the New York State Department of Health (NYSDOH) use a third-party reviewer to authorize diagnostic tests and granted Roche Molecular Systems the agency’s third Emergency Use Authorization for a laboratory developed test.

March 12, 2020 | Daily News

Rep. Mark Pocan (D-WI) urged FDA chief Stephen Hahn to be honest with the public about the number of people that can be tested per day for coronavirus, coming as Hahn and other members of the White House’s Coronavirus Task Force tout the large number of diagnostic test that are being sent out to public health labs and hospitals.

March 10, 2020 | Daily News

Republican senators and administration officials are pushing for a vote this week on bipartisan legislation that would shield certain manufacturers and distributors of masks from lawsuits during the coronavirus outbreak.

March 10, 2020 | Daily News

FDA postponed all of its foreign inspections, effective immediately, until April, FDA chief Stephen Hahn announced Tuesday (March 10) -- coming amid a wave of event and meeting cancellations throughout the United States as coronavirus spreads throughout the country, and as other countries mandate quarantines.

March 06, 2020 | Daily News

By next week, public health labs and hospitals should have enough COVID-19 diagnostic test kits to conduct up to 4 million tests, HHS Secretary Alex Azar told reporters Friday (March 6), shortly after President Donald Trump signed into law an emergency coronavirus supplemental funding bill that gives $61 million to FDA for medical product shortage response efforts and that waives certain Medicare telehealth restrictions during the COVID-19 public health emergency.

March 04, 2020 | Daily News

After years of discussion, delays and controversy, FDA on Wednesday (March 4) finalized a rule it proposed in 2016 that bans use of electrical stimulation devices (ESDs) to treat patients with self-harming or aggressive tendencies.

March 04, 2020 | Daily News

Executives from seven major lab testing companies met with the administration’s Coronavirus Task Force on Wednesday afternoon (March 4) to discuss strategies for quickly disseminating coronavirus diagnostics to as many people as possible.

March 03, 2020 | Daily News

Senate Democrats and Republicans alike said they are concerned the administration is not providing enough affordable and accessible test kits for the coronavirus, after being briefed by top administration officials.

February 28, 2020 | Daily News

FDA announced the first shortage of a human drug as a result of the COVID-19 outbreak and used the opportunity to push legislative proposals it says would help the agency prevent or mitigate medical product shortages.

February 27, 2020 | Daily News

FDA is inviting device makers to voluntarily participate in a pilot that will test a new online application template for premarket clearance, and those participating are expected to have their 510(k) review times cut back and will be allowed to skip a piece of the agency’s preliminary application review process.

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