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Policy & Regulation

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FDA Blames ‘Super Office’ Reorg For Falling Short On 2019 Review-Time Goals For Recalls, High-Risk Adverse Events

The US agency says it missed critical goals for evaluating product recalls and so-called Code Blue Medical Device Reports (MDRs) in fiscal year 2019 – and it’s pinning the blame squarely on a massive reorganization of its device center. This isn’t the first time the FDA has pointed to the “super office” shakeup as a disruptor.

FDA Quality Recalls

Novacyt, Co-Diagnostics, Other Test Firms Seek Fast-Track EUA Approval From FDA For Coronavirus Dx's

Diagnostics companies around the world – including Novacyt, Roche, Co-Diagnostics and Mammoth Biosciences – are developing and launching tests to fight the coronavirus in China and other countries as quickly as possible, and some are seeking Emergency Use Authorization (EUA) approval from the FDA so their assays can be used on US patients.

Regulation FDA Approvals

Regulation

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Warning Letter Nosedive: FDA Makes History (Yet Again) By Sending Only 21 Of The Missives To Device Firms In 2019

A mere 21 quality-related warning letters were issued to device makers last year, the US agency tells Medtech Insight. It’s the third year in a row that the FDA has given out a record-low number of letters. In fact, 2019’s count of 21 represents a whopping 83% decrease from just five years ago, when 121 letters were sent to companies.

FDA Device Warning Letters Enforcement

Latest From Regulation

99 Days Until MDR: Time Is Running Out For Medtech As Risky, Volatile Future Looms

The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.

EU Europe

HHS Advances AI Priorities In Budget Ask

The US Department of Health and Human Services is asking Congress for $10m in its latest budget request specifically to advance the use of artificial intelligence to regulate FDA products and promote development of AI technology. The ask aligns with President Trump’s vision for government agencies to help make the US a leader in AI and machine learning products.

Regulation Policy

11 Notified Bodies Under MDR Now As Ireland’s NSAI Is Officially Designated

With just a few months remaining until the full application of the EU Medical Device Regulation, notified body designations are still only trickling through. Ireland is the latest EU member state to have a resident MDR notified body.

Europe EU

FDA Finalizes Peripheral Vascular Atherectomy Guidance

The US agency made few changes in finalizing a 13 February guidance document on medical devices made to remove plaque from diseased arteries, but did incorporate manufacturer recommendations on corrosion testing and predicate comparisons.

Regulation Medical Device

UK Medicines And Medical Devices Bill Laid Before Parliament

UK health minister Baroness Blackwood will introduce the new UK Medicines and Medical Devices Bill before Parliament today, just before the House of Commons goes into recess. The government wants new legislation for devices and medicines in place before the end of the Brexit transition period.

United Kingdom Regulation

FDA’s Device Center Could Raid $2.8M From Staff Outreach, Training Kitty In 2021 To Fund Other CDRH Needs

While the Trump administration’s proposed fiscal year 2021 budget for the US FDA would give the agency’s device center a 5.3% increase for medtech product approvals and safety, the center’s lofty plans to become the world’s premier regulator of new AI-driven gadgets, next-gen diagnostics and other novel devices means it will have to tap about $2.8m dollars usually set aside for staff training and outreach to help meet its ambitious goals.

Regulation FDA
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Quality Control & Compliance

Set Alert for Quality Control

Fool Me Twice: Chinese Supplier Of Recalled Cardinal Health Surgical Gowns Sparked Quality Concerns Back In 2018

Cardinal Health continued using Siyang HolyMed to supply the firm with so-called Level 3 surgical gowns despite the Chinese contract manufacturer’s track record of quality worries dating back a few years. Meanwhile, the device maker has announced a second recall, this time related to its PreSource Kits that contain the recalled gowns. Cardinal Health says it will likely lose $96m in the second quarter of fiscal year 2020 because of the recalls.

Recalls Quality Safety

Latest From Quality Control

Coronavirus: All FDA Inspections Of Chinese Manufacturing Facilities Come To Screeching Halt

The US agency has suspended all routine surveillance inspections in China through the end of March because of coronavirus fears, commissioner Stephen Hahn announced late on 14 February. Despite expecting medical product shortages, Hahn said the agency is being proactive: “We are not waiting for drug and device manufacturers to report shortages to us” before acting. The timing of Hahn’s statement – at 6 p.m. EST on a Friday, at the beginning of a three-day US holiday weekend – suggests he isn’t particularly excited to share the information.

FDA Enforcement

US FDA Deems MiniMed Safety Issues Class I Recall

Medtronic’s MiniMed 600 series of insulin pumps is the subject of a high-risk class I recall because a component may break, leading to over- or under-dosing of insulin. The company warned patients of the issue last November.

Recalls Safety

US Regulatory Roundup, January 2020: Recalled Surgical Gowns; Coronavirus News; FDA Inspection Tips; And More

News that device giant Cardinal Health recalled millions of potentially unsafe, unsterile surgical gowns – and a message out of the US FDA for customers to “immediately discontinue” using the gowns – was of most interest to our online readers last month. Meanwhile, the FDA’s plans to hasten emergency-use approvals of coronavirus test kits and a set of 10 tips for dealing with agency investigators also garnered significant attention. Here are January’s 10 most popular US policy and regulation stories from Medtech Insight.

Regulation Policy

Loose Cable Leads To Class I Recall For GE Ventilator

A loose cable found in certain models of GE anesthesia machines has resulted in the highest recall alert from the US FDA. Regulators are warning the mechanical problem could result in organ failure and even death.

Recalls Safety

Chinese Device Exports, Supply Chains Holding Up In The Face Of Coronavirus – For Now

Exports of components and finished medical devices coming from coronavirus-stricken China will continue to flow to the US and other countries for now, but there could be trouble soon if government quarantines and international travel bans remain in place, an industry expert in Shanghai tells Medtech Insight.

China Manufacturing

GE Healthcare Recalls Respiratory Monitors Over Display Issue

Some models of GE Healthcare’s CARESCAPE respiratory modules are being recalled because they may incorrectly display a patient’s blood oxygen level. The US FDA has labeled the action a high-risk class I recall.

Recalls Quality Control
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Policy

Set Alert for Policy

Latest From Policy

99 Days Until MDR: Time Is Running Out For Medtech As Risky, Volatile Future Looms

The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.

EU Europe

HHS Advances AI Priorities In Budget Ask

The US Department of Health and Human Services is asking Congress for $10m in its latest budget request specifically to advance the use of artificial intelligence to regulate FDA products and promote development of AI technology. The ask aligns with President Trump’s vision for government agencies to help make the US a leader in AI and machine learning products.

Regulation Policy

11 Notified Bodies Under MDR Now As Ireland’s NSAI Is Officially Designated

With just a few months remaining until the full application of the EU Medical Device Regulation, notified body designations are still only trickling through. Ireland is the latest EU member state to have a resident MDR notified body.

Europe EU

QUOTED. 14 February 2020. Anne Schuchat.

The US Centers for Disease Control and Prevention (CDC) developed a diagnostic test relatively quickly after news hit that a new coronavirus is spreading across China. Now top health officials say diagnostic manufacturers should help scale up the production of these tests. See what Anne Schuchat, principal deputy director of the CDC, said about it here. 

Quoted Policy

Experts: Chinese Tariff Cuts Good For Medtech, But Deliver Small Impact

Two top trade experts tell Medtech Insight that China’s recent decision to reduce tariffs is in response to the US government’s announcement that it, too, would reduce tariffs in an apparent bid to deescalate the seemingly never-ending trade war. Dropping tariffs will also help China meet its obligations under a so-called Phase 1 trade deal agreed to by the two countries.

Trade China

FDA Wants $18M To Update Outmoded Device Program IT Systems

The US agency says its medical device program is in desperate need of an information technology upgrade, noting that its outdated IT systems, tools and approaches could leave it flat-footed when dealing with cybersecurity threats and ever-evolving medtech. That’s why the FDA is asking Congress for $18m to tackle the IT sore spot.

FDA Policy
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