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Policy & Regulation

Set Alert for Policy & Regulation

‘Have Some Level Of Fear’: How Scrapped FDA Inspections, Hastily Made Ventilators Could Portend Product Problems

Two former US FDA officials tell Medtech Insight they’re concerned about product problems down the line as automobile manufacturers make critically needed medical ventilators amid the COVID-19 crisis, and as other device makers quickly scale up manufacturing on items like masks and gowns. Compounding problems is the agency’s decision to stop conducting quality systems inspections at facilities in the US and China.

Manufacturing Safety Quality

FDA Open To Home COVID-19 Testing With Caveats, OIVD’s Stenzel Says; Grants First Serology Test EUA To BD

The US FDA is open to the idea of home-testing for the COVID-19 virus, but only after making sure the test is completely safe and effective, and available only through a physician’s oversight, said Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health. Stenzel also heralded the FDA’s first emergency use authorization for a coronavirus serology test, which was granted to diagnostic developer Becton Dickinson.

Policy Coronavirus COVID-19 FDA

Regulation

Set Alert for Regulation

Industry Asks If Small Business Loan Relief Applies To Companies With Equity Investors

A medtech industry group is asking the Trump administration to clarify if small medical device companies that have equity investors qualify for small business loans and forgiveness under the coronavirus relief package.

Policy Commercial Coronavirus COVID-19

Latest From Regulation

FDA Wants To Put Hep C Tests On 510(k) Pathway

The US FDA has proposed moving two categories of hepatitis C diagnostics to class II from class III because they pose relatively low risk.

Regulation Review Pathway

Facing Shortage, FDA Further Relaxes Face Mask, Face Shield And Respirator Guidance

As the US heads into a COVID-19 storm with grave concerns about the lack of face masks and respirators for health care workers, the FDA has further relaxed federal oversight for such products, giving more responsibility to employers

Distribution Regulation

As China Rushes Medical Supplies To World, Quality Issues Resurface

As China is poised to supply globally medical products to fight coronavirus, a battle to banish its image of poor product quality is on.

Quality Regulation

UK Regulator Puts Energies Into COVID-19 While Other Services May Take Longer

With finite resources, the UK’s regulatory agency responsible for health care products is rapidly addressing COVID-19 medtech issues. But shifting its focus will cause delays elsewhere.

Europe EU

Bodysphere EUA Blunder Is A Lesson In What Not To Do

Hold back on bragging about your emergency use authorizations until you have them in hand, says one expert after diagnostics company Bodysphere had to backtrack its EUA announcement due to a misunderstanding with the US FDA.

Regulation Commercial

FDA OK’s Insomnia Treatment Through Software Pre-Cert Program

Pear Therapeutics’ Somryst insomnia treatment tool has become the first FDA-cleared product that was reviewed through the agency’s Software Precertification Pilot Program.

Commercial Regulation
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Quality Control & Compliance

Set Alert for Quality Control

Quality Should Ride Shotgun As US Auto Makers Rev Engine On Making Ventilators

As American auto giants GM and Ford take the wheel on working with ventilator manufacturers to make the critically needed devices during the COVID-19 pandemic, two longtime quality experts explain where the device and auto companies will find common ground when it comes to quality systems.

Quality Manufacturing Coronavirus COVID-19

Latest From Quality Control

COVID-19 May Delay WHO’s Prequalification Of Devices, IVDs

Work and movement-related restrictions are affecting the ability of companies to provide a timely response to questions relating to their prequalification dossiers.

Quality Safety

COVID-19 Leads FDA To Relax Rules On Surgical Masks, Offer EUAs For Reprocessing Some Respirators

The US agency is relaxing some regulatory requirements on facial masks and actively pursuing ways to reprocess N95 respirators used by medical staff under an immediately-in-effect guidance document.

United States Quality Control

Q4 Recalls Snapshot: Mixed Bag For Industry As Recalls Rise But Number Of Recalled Units Falls

Device makers logged a 14% increase in recalls in the fourth quarter of 2019 – the third quarter in a row that the number of recalled devices went up. Meanwhile, recalled units dropped by 74%.

Recalls FDA

Ford Races To The Rescue: US Auto Maker Partners With GE, 3M To Make Ventilators, Respirators During COVID-19 Crisis

Ford Motor Co. announced partnerships on 24 March with GE Healthcare and 3M Co. to manufacture much-needed medical ventilators and respirators. The auto maker also said it’s developing and testing plastic face shields for health care workers.

Coronavirus COVID-19 Manufacturing

GM Partners With Ventec Life Systems To Make Ventilators

American auto giant General Motors Co. announced late on 20 March that it has teamed up with Seattle-based Ventec Life Systems to manufacture much-needed medical ventilators as the US braces for a strained health care system from COVID-19.

Coronavirus COVID-19 Manufacturing

COVID-19: US Auto Giant General Motors Wants To Make Ventilators, Trump Says; Ford And Tesla Also Express Interest

President Trump said on 20 March that GM wants to manufacture ventilators, a medical device that’s in high demand as the US health care system prepares for an onslaught of patients infected by the novel coronavirus. Fellow auto manufacturers Ford Motor Co. and Tesla Inc. also say they’re willing to make the complex products.

Coronavirus COVID-19 Manufacturing
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Policy

Set Alert for Policy

Latest From Policy

Facing Shortage, FDA Further Relaxes Face Mask, Face Shield And Respirator Guidance

As the US heads into a COVID-19 storm with grave concerns about the lack of face masks and respirators for health care workers, the FDA has further relaxed federal oversight for such products, giving more responsibility to employers

Distribution Regulation

Advanced Imaging Group Calls For Swifter FDA Approvals For Mobile X-Ray, CT, Ultrasound Devices For COVID-19 Crisis

The Medical Imaging & Technology Alliance recently sent a letter to the US FDA recommending steps the agency can take to help the advanced imaging industry quickly respond to the COVID-19 outbreak.

Policy Coronavirus COVID-19

UK IVDs Firms Working Flat Out On COVID-19 Tests, As Govt Promises Test Capacity Increase

Confusion is rife over low UK testing levels to confirm COVID-19 in health care staff and patients, and comparisons with measures taken in similar-sized economies have been unfavorable. Diagnostics manufacturers are not to blame, says the industry.

United Kingdom Coronavirus COVID-19

UK Regulator Puts Energies Into COVID-19 While Other Services May Take Longer

With finite resources, the UK’s regulatory agency responsible for health care products is rapidly addressing COVID-19 medtech issues. But shifting its focus will cause delays elsewhere.

Europe EU

Trump Uses Defense Production Act To Push Ventilator Materials To GE, Medtronic, ResMed, Hill-Rom, Royal Philips And Vyaire

The US president used his DPA powers on 2 April to make sure the six manufacturers of medical ventilators get the materials and components they need to make the much-needed devices as the COVID-19 pandemic scythes through the US.

Coronavirus COVID-19 Manufacturing

EU Regulatory Roundup, March 2020: MDR Delay And Unprecedented COVID-19 Measures

Non-CE-marked products on the EU market, virtual notified body audits, free standards and the Commission bid to pause the MDR. March has seen unprecedented developments as COVID-19 has railroaded through the sector decimating regulatory rules and plans.

Medical Device Europe
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