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Policy & Regulation

Set Alert for Policy & Regulation

Reclassification Order Spurs FDA To Update Computer-Assisted Detection Devices Guidance

To mesh with a final order reclassifying medical-image analyzers, the US agency has also published a final guidance on computer-assisted detection (CADe) devices that was first finalized more than six years ago.

Regulation Artificial Intelligence Clinical Trials

Medtronic Faces Surgical Stapler Lawsuits In Minnesota, Texas

Three patients have filed suit against Medtronic in recent weeks alleging they were injured by malfunctioning surgical staplers made by the company. The lawsuits add to recent scrutiny of the device type’s safety.

United States Regulation Safety

Regulation

Set Alert for Regulation

Warning Letter Roundup & Recap – 21 January 2020

A maker of low-level LED light-therapy devices was cited by the US FDA for premarket, quality systems and Medical Device Reporting violations. It's just one of two device-related warning letters released by the agency this week.

Device Warning Letters FDA Enforcement

Latest From Regulation

Will MDR Delays Create Roadblocks For Companion Diagnostics Regulation?

Companion diagnostics are needed increasingly by pharma companies to justify the safety and effectiveness of their products. With specific first-time EU regulation of these products within sight – and urgently needed – is there a risk of delays to these products being able to demonstrate compliance?

Europe EU

Australian Fees To Rise As Registrations Decline

The Therapeutic Goods Administration says that its cost-recovery fees need to go up, mainly because of a fall in the number of products on the therapeutic products register. It is also seeing a rise in the cost of the fee-free services it provides.

Australia Regulation

Petition Argues FDA Has Overstepped In PGx Regulation

A group of manufacturers and clinicians is asking the US agency to allow more discussion between manufacturers, labs and clinicians of how genetic factors could influence drug effectiveness  an area known as pharmacogenomics (PGx). The FDA had previously taken several steps to limit these communications.

Diagnostics Regulation

EU Nomenclature Mapping Project News: Will Critical Progress Be Hampered By Tensions?

It seems to be game over for anyone who might have been hoping the European Commission would do a U-turn on its decision to use the Italian CND nomenclature as the basis for communication in Eudamed, instead of the well-established GMDN. But GMDN is strong in its resolve to remain a vital global nomenclature service.

Medical Device In Vitro Diagnostics

Essure Update: Almost All Unsold Units Back To Bayer; Postmarket Study Enrollment Complete

The US FDA says Bayer has successfully recovered unsold Essure units and completed enrollment in a Sec. 522 postmarket study, fulfilling deadlines set at a year from the date the devices were taken off the US market.

Post Market Regulation & Studies Regulation

Powered Wheeled Stretchers Now 510(k)-Exempt

Manufacturers won’t need to submit 510(k)s for powered wheeled stretchers under a new order from the US FDA.

Review Pathway Regulation
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Quality Control & Compliance

Set Alert for Quality Control

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 6)

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this sixth installment of a 10-part series, experts David Elder and John McKay address communication between the front room – where investigators do the majority of their work – and the back room, used by company workers to fulfill investigator requests for documents, records and other information.

Compliance Corner FDA Enforcement

Latest From Quality Control

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 5)

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this fifth installment of a 10-part series, the experts address so-called front rooms used by manufacturers during an inspection.

Compliance Corner FDA

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 4)

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this fourth installment of a 10-part series, the experts address so-called back rooms used by manufacturers during an inspection.

Compliance Corner FDA

‘Immediately Discontinue’ Using Potentially Nonsterile Surgical Gowns, Packs From Cardinal Health, FDA Warns; Company Assessing Quality Issues

The US agency is telling health-care providers to yank specific gowns – and procedural packs that contain the gowns – from shelves because their maker, Cardinal Health Inc., cannot assure their sterility. The agency is also warning that the problem could lead to a shortage of so-called Level 3 gowns, which are used in a wide-array of everyday surgical procedures.

Recalls Quality

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 3)

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this third installment of a 10-part series, the experts address the do’s and don’ts of responding to investigator requests for information and records.

Compliance Corner FDA

Q3 Recalls Snapshot: Number Of Recalls Ticks Up For Third Consecutive Quarter; Recalled Units Spike An Incredible 1013%

Device makers initiated 243 recalls in the third quarter of 2019 – a modest 1% increase over Q2’s 200 recalls. Interestingly, the number of recalled device units skyrocketed a whopping 1013%, from 19.7 million in Q2 to 219.2 million in Q3. Check out our Q3 recalls infographic.

Recalls FDA

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 2)

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this second installment of a 10-part series, informational slide decks used during an inspection's opening meeting are discussed by former FDA officials David Elder and Steve Niedelman.

Compliance Corner FDA
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Policy

Set Alert for Policy

Latest From Policy

Will MDR Delays Create Roadblocks For Companion Diagnostics Regulation?

Companion diagnostics are needed increasingly by pharma companies to justify the safety and effectiveness of their products. With specific first-time EU regulation of these products within sight – and urgently needed – is there a risk of delays to these products being able to demonstrate compliance?

Europe EU

US Senate Approves US-Mexico-Canada Agreement Championed By Industry

The US Senate overwhelmingly approved a bill on 16 January to implement the US-Mexico-Canada agreement, which includes a new chapter on the handling of medical devices supported by the medtech industry.

Policy Trade

US Research Agency AHRQ Puts Out Call For Non-Pharma-Based Pain-Control Device Studies

The Agency for Healthcare Research and Quality (AHRQ) is conducting a review on treatments for acute pain and is asking device manufacturers and other organizations to supply it with studies on nonpharmacological therapies to control pain, including transcutaneous electrical nerve stimulation, ultrasound, heat- and cold-producing devices, and acupuncture.

Policy Comparative Effectiveness

EU Nomenclature Mapping Project News: Will Critical Progress Be Hampered By Tensions?

It seems to be game over for anyone who might have been hoping the European Commission would do a U-turn on its decision to use the Italian CND nomenclature as the basis for communication in Eudamed, instead of the well-established GMDN. But GMDN is strong in its resolve to remain a vital global nomenclature service.

Medical Device In Vitro Diagnostics

Former Palliative-Care Firm CEO Brad Smith Appointed Head Of CMS Innovation Center

Brad Smith, the former CEO of Aspire Health, a home-based palliative-care company, was appointed director of the Center for Medicare and Medicaid Innovation (CMMI) at the US Medicare agency CMS.

Policy Appointments

Medtronic Wins In England’s NICE Decision On Implantable Monitors For Stroke Patients; Biotronik And Abbott Lose

UK health technology assessment body NICE says that Medtronic’s Reveal LINQ, which transmits data remotely to doctors, is likely to be a cost-effective use of National Health Service resources.

Health Technology Assessment United Kingdom
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