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Policy & Regulation

Set Alert for Policy & Regulation

Random Checks Now Routine: China To Inspect Your Factories Near And Far

A new regulation in China legalizes overseas inspections of device- and drug-makers, making risk-based audits routine tasks.

China Manufacturing Compliance

NZ To Replace 'Outdated And Piecemeal' Device Rules

There are significant changes in store for New Zealand’s medical device sector, including a new regulator and a set of pre- and post-market regulatory controls.

New Zealand Policy & Regulation Clinical Trials
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Regulation

Set Alert for Regulation

Pre-Cert Program Will Start Off Slow With De Novo Framing, But Big Questions Remain

Several experts suggest FDA is toeing the line in keeping the first stage of its pre-certification program for software-as-a-medical-device products legally permissible, but it may be limited in scope for the time being. Meanwhile, one attorney says the agency is sending mixed messages about whether the current program will sit comfortably within FDA's current authorities.

Digital Health Regulation Medical Device

Latest From Regulation

IVDR Notified Body Numbers – Has Enough Progress Been Made?

Will there be enough resources for IVD manufacturers to be audited in time against the EU's IVD Regulation? A survey from TEAM-NB reveals a drop in notified body numbers just at a time when more resources are needed.

Medical Device Europe

DTC Ads For Genetic Tests Increased 18-Fold Over 20 Years, Study Says

The number of direct-to-consumer advertisements for molecular-based tests rose exponentially from 1997 to 2016, according to a medical marketing analysis released earlier this month in the Journal of the American Medical Association. Simultaneously, laboratory test manufacturers increased spending on ads and direct spending on physicians who work with the tests from $75.4m to $82.6m.

In Vitro Diagnostics Advertising, Marketing & Sales

Coordinated Antimicrobial Drug/Device Development Addressed In FDA Final Guidance

In its bid to fight antimicrobial resistance, the agency has finalized a 2016 guidance on how novel antibiotic developers can coordinate with antimicrobial susceptibility test-makers to ensure their products come to market at about the same time. The agency recommends using its pre-submission process for a more efficient review.

Regulation In Vitro Diagnostics

Paclitaxel-Coated PAD Devices Under US FDA Scrutiny

The agency sent a letter to health-care providers stating that it is investigating reports of an elevated risk of death for patients starting two years after treatment with paclitaxel-coated balloons or paclitaxel-eluting stents. But FDA is not taking any regulatory action at this point.

Safety Regulation

Expect FDA Diagnostics-Reform Bill Passage In 2019, Rep. DeGette Says

Passage of a US FDA diagnostics reform bill is one priority for the US House Energy and Commerce Committee in 2019, said cosponsor and committee member Rep. Diana Degette, D-Colo.

Legislation In Vitro Diagnostics

Swissmedic Updates Class I Medical Device Notifications, Levies Fees

Cost-recovery requirements have induced regulator Swissmedic to introduce notification fees for lower-risk, class I devices, IVDs and products that use non-viable human tissues, with immediate effect.

Switzerland Regulation
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Quality Control & Compliance

Set Alert for Quality Control

Benefit-Risk Is Front-And-Center In Latest Revision Of International Risk Management Standard ISO 14971

The International Organization for Standardization (ISO) has strengthened benefit-risk language in the latest redo of ISO 14971, the voluntary standard that instructs device-makers on how to best put together a risk management program. Regulators – including US FDA – are increasingly considering benefit-risk when weighing product availability and regulatory compliance issues. And Jos Van Vroonhoven, convener of a joint working group that revised the standard, says a more global regulatory emphasis on risk management and a desire to clarify the document in general led ISO to revise the standard. Also: Van Vroonhoven identifies four updated clauses in the revamped standard that firms should keep a sharp eye on.

Risk Management Standards International

Latest From Quality Control

Compliance Corner: J&J Quality Expert Urges Makers Of Combo Products To Be 'Bilingual' In Device- And Drug-Speak

Speaking the language of both devices and drugs is an important step sometimes missed by makers of combination products. Being "bilingual" is especially important during a facility inspection by US FDA, Johnson & Johnson's Susan Neadle says.

Compliance Corner Combination Products

The Path Forward: Retooled Technical Doc TR 24971 Guides Device Firms On Risk Management Standard ISO 14971

When ISO TR 24971 – a Technical Report that offers device-makers guidance on international risk management standard ISO 14971 – was first published in 2013, not many people knew it existed. But now that the TR is being updated in tandem with ISO 14971, it's a must-have document that includes valuable instruction related to a host of risk-related issues. In particular, TR 24971:20XX includes informative new annexes that tackle device cybersecurity and how firms should handle risk management for products designed before ISO 14971 existed.

Risk Management Standards

Crosswalk: ISO 14971:2007 Vs. ISO 14971:20XX

Here's a table cross-referencing the current 2007 version of international risk management standard ISO 14971 and its revised draft version, which will likely be published by the International Organization for Standardization (ISO) later this year.

Risk Management Standards

'Implant Files': New Device-Failure Database Benefits Companies And Savvy Consumers, But May Befuddle Others, Experts Say

The International Medical Devices Database from the International Consortium of Investigative Journalists – an output of ICIJ's recent string of "Implant Files" stories that were critical of industry – offers information on more than 700,000 device recalls, field safety notices and safety alerts documented in 11 countries. While device-makers and shrewd consumers will discover a bevy of useful data in the public repository, it could prove confusing for laypeople. A recalls expert and an ex-FDA official weigh in.

Implant Files International

FDA's Maisel Updates Industry On Maturity Model Pilot, Facility Inspections, MDSAP

US FDA device center official William Maisel offered an update on the agency’s ongoing efforts at an industry conference last week, touting recent successes in Medical Device Single Audit Program (MDSAP) expansion and its Voluntary Medical Device Manufacturing and Product Quality Pilot Program.

FDA Quality

Adverse-Event Reporting Failure Leads To Guilty Plea For Olympus, Exec

Olympus Medical Systems and a former senior executive have pleaded guilty to allegations that they sold duodenoscopes even after failing to submit required adverse-event reports on them.

Legal Issues Enforcement
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Policy

Set Alert for Policy

Latest From Policy

AdvaMed Code Update Focuses On Compliance Standards

AdvaMed has revised its industry Code of Ethics. The revised code, which will come into effect in 2020, includes new sections on off-label communications and training health-care professionals to use new medical technology.

Compliance Medical Device

IVDR Notified Body Numbers – Has Enough Progress Been Made?

Will there be enough resources for IVD manufacturers to be audited in time against the EU's IVD Regulation? A survey from TEAM-NB reveals a drop in notified body numbers just at a time when more resources are needed.

Medical Device Europe

Expect FDA Diagnostics-Reform Bill Passage In 2019, Rep. DeGette Says

Passage of a US FDA diagnostics reform bill is one priority for the US House Energy and Commerce Committee in 2019, said cosponsor and committee member Rep. Diana Degette, D-Colo.

Legislation In Vitro Diagnostics

New Finance Chair Grassley Will Push Device Tax Repeal, Try To Lower Health-Care Costs

In setting his agenda for the US Senate Finance Committee in 2019, incoming Chairman Chuck Grassley, R-Iowa, says he will continue to cosponsor bills to end the device tax, focus on lowering prescription drugs and other medical product health-care costs, expand tax breaks for business, and make sure Congress has a strong hand in negotiating trade and tariff talks.

Legislation Regulation

Lawsuit Seeks Expanded Medicare Reimbursement For CGM

A law firm has filed a class action suit against the US Department of Health and Human Services trying to force broader Medicare reimbursement of continuous glucose monitors. Currently, federal health programs will only cover specific types and uses of the diabetes treatment technology.

Legal Issues Reimbursement

Notified Bodies And EU Industry Voice Separate, But Aligned Frustrations Over Slow Progress In NB Designations

Notified body and medtech industry trade associations both issued formal statements pointing out that delays in designating notified bodies are the biggest barrier to products being able to comply with the new EU Medical Device Regulation before deadlines. Time is running out.

Europe Medical Device
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