Policy & Regulation

FDA allows for infusion pump modifications to prevent shortages

In a bid to "reduce supply chain interruptions and manufacturing bottlenecks" during the pandemic, the agency will permit some changes to the pumps and accessories without the added step of a new 510(k) submission.

By Susan Kelly • April 06, 2020

FDA authorizes Cellex coronavirus antibodies test

It's the first test of its kind to obtain FDA emergency use authorization, although other companies are working to roll out serological tests for the virus.

By Maria Rachal • April 03, 2020

Industry cheers COVID-19 executive order to boost ventilator supply chain

While AdvaMed has pushed back on using the Defense Production Act, the move is meant to help domestic manufacturers by removing hurdles to accessing parts and materials needed to ramp up production of ventilators.

By Greg Slabodkin • April 03, 2020

Medtechs navigate new normal as FDA shifts priorities to coronavirus

Companies are working to get diagnostics, respiratory devices and PPE to market amid rapidly evolving guidance from FDA. The agency's coronavirus-era operations may also impact work for device makers in other parts of the sector.

By Maria Rachal • April 03, 2020

NuVasive suspends UK sales of Magec rod amid safety concerns

The move comes after regulators called for quarantining affected devices and X-rays for patients within three months to check for end cap separation, although the COVID-19 crisis could delay such actions.

By Nick Paul Taylor • April 02, 2020

BD rolls out test to detect coronavirus antibodies

Some experts point to serology tests, which may help identify people who have immunity, as a key tool in U.S. management of COVID-19 going forward. The BD test has already seen significant use in China.

By Susan Kelly • April 01, 2020

Remote patient monitoring, ventilator payment among CMS flexibility as COVID-19 rages on

As many patients have required ventilators, Medicare will now cover respiratory devices and equipment for any medical reason a doctor determines instead of only under specific conditions. 

By Shannon Muchmore • March 31, 2020

FDA flags Class I recall of Medtronic brain stent, citing fracture reports

The agency has received at least 50 reports, including of 10 injuries and one death, tied to an issue with the delivery system that places the aneurysm-treating device in the artery. 

By Susan Kelly • March 31, 2020

High-risk devices with expedited reviews more likely to be recalled, research suggests

As FDA's Breakthrough Devices Program rises in popularity, a JAMA Internal Medicine analysis found almost two-thirds of Class III devices approved with priority review status between 2005 and 2015 were recalled.

By Nick Paul Taylor • March 31, 2020

AdvaMed wary of Trump's use of DPA to boost ventilator production

The medtech industry contends the Defense Production Act could strain the supply chain, but the administration says it's "working to sign contracts immediately" with GE, Medtronic, ResMed and other major manufacturers.

By Greg Slabodkin • March 30, 2020

Digital health advice from FDA amid coronavirus leaves more questions than answers

While the agency doesn't consider most apps and software systems for COVID-19 public health surveillance and communication to be regulated medical devices, the scope of regulation remains murky.

By Greg Slabodkin • March 27, 2020

FDA outlines role for 3D printing in coronavirus response, with some caution

Additive manufacturing has emerged as a tool to help bolster availability of critical devices like ventilators and testing supplies, but the agency said 3D-printed personal protective equipment may not be as effective.

By Nick Paul Taylor • March 27, 2020

Small PAMA victory in aid package, but labs remain in 'untenable situation'

Quest, LabCorp and others scaling up U.S. coronavirus testing will see a delay in Medicare payment reductions as part of the CARES Act signed into law Friday, but industry argues labs have been shortchanged on emergency funds.

By Maria Rachal • UPDATED: March 27, 2020 at 5:20 p.m.

FDA OKs anesthesia gas machines as ventilators amid coronavirus shortage fears

GE Healthcare, which has more than 100,000 of its anesthesia devices worldwide, noted differences but acknowledged the "need to weigh the relative risks and benefits to support patients in these unprecedented times."

By Greg Slabodkin • March 26, 2020

UnitedHealth says self-swabbing study spurred FDA coronavirus policy change

The agency now allows onsite, self-collection of samples, after a nearly 500-patient study found self-administered tests about as accurate as those carried out by clinicians.

By Nick Paul Taylor • March 26, 2020

Medtech industry asks for FEMA's help allocating ventilators to frontlines

AdvaMed said a lead federal agency should be designated to manage distribution of the breathing machines as manufacturers rapidly scale up production in response to the COVID-19 crisis.

By Susan Kelly • March 25, 2020

How health systems are responding as COVID-19 squeezes the medical supply chain

Procurement of supplies will become more difficult if cases surge and federal stockpiles don't trickle down to the state level quickly enough.

By Deborah Abrams Kaplan • March 25, 2020

EU regulators propose 1-year MDR delay

The European Commission formally proposed Friday the Medical Device Regulation start date be moved to May 26, 2021. It needs the quick backing of the European Parliament and Council.

By Maria Rachal • UPDATED: April 3, 2020 at noon

FDA still trying to fine-tune Pre-Cert as pilot enters 2020

The Pre-Cert​ pilot, which includes Apple, J&J and Fitbit, is moving forward with the agency "working through the nine companies, trying to figure out how they actually do business," FDA's Bakul Patel told MedTech Dive.

By Greg Slabodkin • March 25, 2020

Clinical labs, White House tell different stories on testing backlog

The American Clinical Laboratory Association said without sufficient funds from the federal government, commercial labs might be forced to "retrench rather than keep building the capacity that is needed."

By Greg Slabodkin • March 24, 2020

MedTech Europe calls for delay of MDR until coronavirus crisis passes

The trade group argued industry is “working relentlessly” on getting devices to healthcare professionals fighting COVID-19, while simultaneously trying to maintain supply of other products, leaving little bandwidth to focus on new regs.

By Nick Paul Taylor • March 24, 2020

FDA eases rules on ventilator makers as Medtronic and Tesla talk

Hardware and software modifications can occur without submission of a 510(k) as traditional medtechs team with other manufacturers to meet coronavirus-driven demand for the devices.

By Nick Paul Taylor • March 23, 2020

FDA greenlights expanded remote patient monitoring to keep patients out of coronavirus-slammed hospitals

The agency said it wants to help healthcare providers diagnose and treat patients who remain at home in the midst of the national emergency.

By Susan Kelly • March 20, 2020

Lab industry 'alarmed,' says Senate stimulus bill fails to back testing ramp-up

Without $5 billion in assistance, the American Clinical Laboratory Association contends commercial labs are "being set up to perform COVID-19 testing at a loss." A Senate vote could come Monday.

By Greg Slabodkin • UPDATED: March 23, 2020 at 10:29 a.m.

US won't suspend China tariffs during coronavirus outbreak

The tariffs present a risk and additional cost to medical supply chains as the need for critical products grows urgent. 

By Shefali Kapadia • March 19, 2020