Policy & Regulation: Page 2

CDC chief: Reagents critical to coronavirus tests​ 'now are in short supply'

Separately, the government Friday announced funding for development of COVID-19 diagnostic tests from DiaSorin Molecular and Qiagen meant to detect the pathogen in about an hour. 

By Greg Slabodkin • March 13, 2020

As US officials shift tone on coronavirus, Trump stops short of 1 provider ask

The president did not declare a disaster or national emergency, which groups like the American Hospital Association had sought.

By Samantha Liss , Shannon Muchmore • March 12, 2020

TransMedics to get FDA expert review for heart transplant device PMA

The agency's Circulatory System Devices Panel is set to vote April 16 on recommendations regarding the organ preservation medtech's system for donor hearts.

By Maria Rachal • March 12, 2020

FDA chief warns of supply 'pressure' on reagents for coronavirus tests

Qiagen, a major supplier of RNA extraction kits, confirmed to MedTech Dive Thursday that "extraordinary demand for coronavirus testing workflows" is challenging the company's capacity.

By Greg Slabodkin • March 12, 2020

FDA finalizes contentious guidance on third party 510(k) reviews

Meant to enable faster decisions and free up the agency to focus on higher risk devices, earlier versions took fire from AdvaMed and some patient groups.

By Nick Paul Taylor • March 12, 2020

White House, CDC under fire for availability of coronavirus tests

The Trump administration is facing criticism that federal agencies did not engage the big private labs early enough in the public health emergency.

By Greg Slabodkin • March 11, 2020

FDA issues Class I recall for Medtronic's HeartWare HVAD after patient death

A design flaw flagged by Medtronic in January regarding its ventricular assist devices landed a high-risk label from regulators this week.

By Nick Paul Taylor • March 11, 2020

Key EU notified body meeting goes on, virtually

A Medical Device Coordination Group meeting, parts of which are postponed, comes as Germany, home to four of 11 notified bodies designated under EU MDR, anticipates widespread COVID-19 transmission.

By Nick Paul Taylor , Maria Rachal • March 11, 2020

Coronavirus spread prompts FDA to postpone nearly all overseas inspections

The agency based the decision on U.S. government travel restrictions and advisories, saying "alternative tools and methods" will help maintain oversight.

By Jonathan Gardner • March 10, 2020

FDA updates guidance on 510(k) submissions for electrosurgical devices

The agency offered greater detail on testing requirements in assessing thermal tissue damage.

By Susan Kelly • March 10, 2020

Labs step up capacity to meet demand for nationwide coronavirus testing

The Trump administration is relying on the "enormous capacity" of commercial labs to enable wide availability of COVID-19 diagnostic testing to the American public through physicians offices and pharmacies. 

By Greg Slabodkin • March 10, 2020

Long-awaited interoperability rules finalized by Trump admin, prompt industry ire

Providers and entrenched health IT interests are unlikely to be happy with the final iterations, which largely mirror the proposed versions. One win: The timeline to come into compliance has been pushed back.

By Rebecca Pifer • March 09, 2020

ACC 2020 meeting canceled as coronavirus spreads in US

Abbott, Edwards and Medtronic were among the medtechs slated to present data at the American College of Cardiology's annual event. "This is a unique time for us all," the organization wrote in a statement Monday.

By Maria Rachal • March 09, 2020

Cardiologist groups back Abbott push to change heart device coverage

Some feedback to CMS supports a retreat from potentially restrictive terms used with ventricular assist devices. Responses to SynCardia’s separate bid to permit the use of artificial hearts outside of clinical trials were more mixed.

By Nick Paul Taylor • March 06, 2020

$8.3B in coronavirus funding set in motion as federal agencies ramp up response

The House and Senate passed a bill with allocations for medical supplies and testing as Vice President Mike Pence met with clinical lab execs Wednesday from LabCorp, Quest Diagnostics, Thermo Fisher and others.

By Shannon Muchmore • UPDATED: March 5, 2020 at 4:08 p.m.

UK looks to use Brexit to make device industry more transparent

The House of Commons bill seeks to address a regulatory gap for medical devices, as the previous legal framework is based on EU directives. One element provides new information-sharing powers related to safety.

By Nick Paul Taylor • March 05, 2020

Some pacemakers, EKGs, diabetes devices may face newly flagged Bluetooth cyber risk

FDA and the Department of Homeland Security said microchips from seven manufacturers and a range of consumer wearables and connected medical devices may be affected.

By Susan Kelly • March 04, 2020

FDA bans certain electrical stimulation devices called 'barbaric'

Amid mounting pressure from lawmakers, the agency handed down its third-ever medical device ban, finalizing a 2016 proposal prohibiting current and future sale of certain devices to treat self-injury or aggressive behavior.

By Maria Rachal • March 04, 2020

AdvaMed, Medtronic among top 20 pharma and health product lobbyists over 2 decades: study

The medical devices trade association spent $79.4 million on lobbying from 1999 to 2018, making it the fifteenth biggest spender.

By Nick Paul Taylor • March 03, 2020

Olympus-backed Medi-Tate gets FDA nod for prostate device

The Japanese corporation has an option to buy the Israeli startup and its newly De Novo-authorized benign prostatic hyperplasia device.

By Nick Paul Taylor • March 03, 2020

Supreme Court to again decide fate of ACA

The high court said Monday it would hear the case that seeks to overturn the Affordable Care Act pushed by Texas and other red-leaning states.

By Samantha Liss • UPDATED: March 2, 2020 at 10:38 a.m.

FDA seeks 'right balance' as it permits immediate use of coronavirus tests

"We are not changing our standards for issuing Emergency Use Authorizations," Commissioner Stephen Hahn said Saturday as the agency issued new guidance aimed at accelerating testing capacity in the U.S.

By Susan Kelly • March 02, 2020

Coronavirus: No US shortages of essential devices yet, as FDA monitors more than 60 companies

Still, manufacturers operating 72 plants in China face workforce pressures and surging demand for some equipment, FDA said in an update late Thursday.

By Nick Paul Taylor • Feb. 28, 2020

California's new cybersecurity law sidesteps most medical devices, lawyers say

How the state enforces its "internet of things" or connected devices law "may end up becoming a source of persuasive authority for the FDA in its decision making" on cybersecurity guidance, said White and Williams' Joshua Mooney.

By Fred Donovan • Feb. 28, 2020

FDA posts trio of medical device warning letters

An apparent flurry of enforcement activity disclosed this week comes shortly after the agency signaled a return to greater vigilance following a nearly 90% decline in device-related warning letters from 2015 to 2019.

By Nick Paul Taylor • Feb. 28, 2020