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Policy & Regulation

Set Alert for Policy & Regulation

Unfinished Business: LDT Legislation A Top Priority For Departing FDA Chief Gottlieb

In a farewell talk at the Brookings Institution, outgoing US FDA Commissioner Scott Gottlieb said a top unfinished business that he hopes gets done after his April departure is legislation to regulate laboratory developed tests. While FDA had been looking to issue guidance on LDTs, he argues there isn’t sufficient legal authority for the agency to regulate the sector.

FDA Leadership Policy

Neuro Devices Panel Skeptical On Alzheimer’s Treatment

The US FDA neurological devices panel on March 21 found significant faults with Neuronix’s de novo application for its neuroAD Alzheimer’s treatment system. A key concern was that the device missed its primary endpoint in the pivotal trial.

Advisory Committees Neurology Neurology


Set Alert for Regulation

Device Week, March 22, 2019 – Goings-On At US FDA

In this week’s podcast, senior reporters Elizabeth Orr and Ferdous Al-Faruque give a quick rundown of FDA goings-on the device industry should keep a sharp eye on, including a reorganization of the Center for Devices and Radiological Health, remarks from outgoing agency head Scott Gottlieb on laboratory developed tests, and news from a recent FDA neurological devices advisory panel meeting.

Device Week FDA Policy

Latest From Regulation

Podcast: Gottlieb Addresses LDT Legislation At Brookings

US FDA Commissioner Scott Gottlieb spoke with Medtech Insight about the agency’s decision to put the LDT issue to Congress instead of using guidance-making.

FDA Legislation

Beyond Mad Cow: FDA’s Updated Animal Component Guidance Looks To Limit Spread Of More Diseases

US FDA has updated a final guidance on the use of animal components in medical devices. The new version incorporates precautions intended to limit the transmission of a wider range of diseases, while the original focused on bovine spongiform encephalopathy (mad cow) disease.

FDA Guidance Documents

No Brainer: US FDA Greenlights First Biomarker Software As Medical Device Development Tool For Brain Injury

Developers of medical devices intended to treat traumatic brain injuries may want to consider using an imaging software developed to detect contusions. The product is the third Medical Device Development Tool qualified by US FDA, which means the agency trusts it to output accurate data supporting clinical trials.

FDA Clinical Trials

FDA Tells Providers To Limit Use Of Paclitaxel-Coated Stents

New US FDA analysis of paclitaxel-coated devices to treat peripheral arterial disease matches previous reports of an increased death risk tied to use of the devices. The agency is encouraging providers to look to other treatment options while analysis continues.

Safety Medical Device

Danish Agency Claims A First In Raw Data Analysis

The Danish Medicines Agency says it is about time that EU regulators developed US FDA-style capabilities to analyze raw data so that they can make better use of the opportunities provided by big data. Agency chief Thomas Senderovitz tells Medtech Insight how Denmark is setting up a unique data analytics center for medical devices and drugs without reinventing the wheel.

Denmark Europe

FDA Focusing More On Safety Of Device Biomaterials, Attorney Warns

Device-makers will have to take a more proactive approach to understanding the safety of biomaterials they use for their implanted devices, and how these materials might affect patients during post-market use, industry attorney Michele Buenafe of Morgan Lewis & Bockius LLP told Medtech Insight in a March 18 interview.

Regulation Safety
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Quality Control & Compliance

Set Alert for Quality Control

FDA Says It's Approving Change Notices 3 Weeks Faster For Firms In CMMI Maturity Model Program; 40+ Inspections Waived

The US agency is approving 30-day change notices at a breakneck pace for device-makers enrolled in an ongoing program that measures manufacturing maturity and quality using an industry-modified version of the Capability Maturity Model Integration (CMMI) framework. FDA also says it has waived 40 routine and four pre-approval inspections as part of the program – a help not only to device firms, but to the agency as it considers where best to use its scarce inspectional resources.

FDA Manufacturing Quality

Latest From Quality Control

Warning Letter Roundup & Recap – March 19, 2019

Two makers of breast implants failed to comply with years-old FDA post-approval study orders, and TEI Biosciences Inc. – an Integra LifeSciences company – ran afoul of the US agency's Quality System Regulation in device-related warning letters released by FDA this week.

Device Warning Letters FDA

FDA Eyes Upclassification, Labeling Guidance To Address Stapler Risks

The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.

Quality Control Safety

California Company Surprised After Getting Slammed By US FDA For Marketing Of Imaging Device

Total Thermal Imaging, a company that promotes thermal imaging technology over mammography to detect breast cancer, says it is surprised the agency is coming after them for "illegally marketing" their test for unapproved indications. The company says it thought it had complied with all of FDA’s requirements but  is willing to consider filing a 510(k) if needed.

Quality Control Regulation

Warning Letter Roundup & Recap – Feb. 26, 2019

Intra-aortic balloon pump manufacturer Datascope was cited for quality systems violations, and maker of the Thermography Business Package for thermal imaging was cited for pre-market violations in the only device-related warning letters released by US FDA this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Feb. 19, 2019

A Beverly Hills doctor was slapped with a US FDA warning letter for quality systems, Medical Device Reporting and pre-market issues related to a device used during breast augmentation procedures, and an Oyster Bay, NY, specification developer of the Better Bladder device was instructed by the agency to hire a consultant to help fix its quality systems issues. Two other missives were released this week – the first device-related warning letters posted online by FDA since early December 2018.

Device Warning Letters FDA

FDA Draft Guidance Outlines Agency's Plan To Offer Nonbinding Feedback On Form-483 Observation Resolutions

Device manufacturers would be able to get nonbinding feedback on their plans for how to resolve some Form-483 inspectional observations from US FDA officials under a new draft guidance released Feb. 15.

Guidance Documents FDA
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Set Alert for Policy

Latest From Policy

Podcast: Gottlieb Addresses LDT Legislation At Brookings

US FDA Commissioner Scott Gottlieb spoke with Medtech Insight about the agency’s decision to put the LDT issue to Congress instead of using guidance-making.

FDA Legislation

UK Champions Oxfordshire As Next Global Digital Health Hub

The UK government is championing the region of Oxfordshire to become the next global digital health hub post-Brexit. The ambitious plans to develop the UK’s digital health technologies were outlined at a recent event at the House of Commons in London.

United Kingdom Artificial Intelligence

Physicians Failing To Disclose Supplier, POD Arrangements Fuel Kickback Concerns, Senators Say

US Senate Finance Committee leaders say some physicians may have failed to disclose their physician-ownership interests in entities that offer medical supplies to the physician’s own practice, as required under the Physician Payment Sunshine Act. The legislators on March 19 prodded the Health and Human Services' Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) to take a closer look into these arrangements.

Reimbursement Enforcement

Podcast: MDMA CEO Mark Leahey On Industry's Hot Topics

In an exclusive interview with Medtech Insight, MDMA's Mark Leahey – one of industry's top lobbyists – talked about the group's priorities over the past year and its continued work on hot-button issues, including medical device-tax repeal, reimbursement and implementing MDUFA IV provisions. He also discussed the imminent departure of US FDA Commissioner Scott Gottlieb and the recent federal government shutdown.

United States FDA

FDA Device Center Reorg Set To Roll Out This Week

US FDA's Center for Devices and Radiological Health will finally launch a long-planned reorganization that will see agency staff grouped by device types, rather than by stage in the device-review cycle. The reorganization begins this week and should be complete by Sept. 30.

FDA Policy

UK Medtech Market Access: More About Mindset Than The Money

The journey from medtech concept to implementation is long and slow, and new ideas often don’t make it all the way to manufacturing and approval. But when they do, what is needed is a system that guarantees adoption and usage of those proven, innovative solutions that clear the many hurdles en route to clinical practice.

Medical Device United Kingdom
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