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Policy & Regulation

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Medtech's Unfinished Business For Congress In 2018: What's Ahead

US Congress successfully pushed through a user-fee bill in 2017 to help smooth the regulatory path at FDA for medical devices and other products, but other efforts, including several industry priorities, remain undone. On top on the list, of course, is the effort to repeal the device excise tax. But legislation is also on the table to address diagnostics regulation, telehealth reimbursement, and medtech cybersecurity vulnerability, among other issues. Here is a look at the medtech landscape in Congress in 2018.

Policy Legislation United States

2018 An Inflection Point For mHealth After An Active Year

The past year saw US FDA and industry work hard and fast to prepare for what looks like an inevitable boom in the digital-health sector. According to interviews, the time is ripe for adoption of mobile health apps to help reduce health-care costs, but the brave new world also brings with it big challenges.

Digital Health Analysis Cybersecurity
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Regulation

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Swiss Timing Is Spot-On For EU Medtech Reg Integration

Switzerland, outside the EU and the European Economic Area, has been efficient in preparing to work under the new EU medtech regulations. It’s a hoped-for model for UK stakeholders as Brexit trade talks approach.

Switzerland EU Regulation

Latest From Regulation

Military Products Will Get US FDA Fast-Track Review

FDA and the US Department of Defense launched program to prioritize development of medical products for use in the battlefield. The program implements recently enacted compromise legislation that resolved a turf battle between the two agencies.

Regulation FDA

Least Burdensome Additional-Info Requests? US FDA Needs Metrics, GAO Says

The US Government Accountability Office says FDA needs more information to prove that is properly applying least-burdensome concepts for deficiency or additional-information letters sent to companies while reviewing pre-market submissions. FDA defends its performance, but plans to conduct more assessments.

Regulation FDA

US FDA Extends UDI Deadlines For Low-Risk Devices

The agency slowed down its effort to require the overwhelming majority of medical devices to adopt Unique Device Identifiers with a a new guidance that would in delay full implementation of the UDI system for lower-risk devices.

Regulation Medical Device

New EU Task Force Finalizes First Document

As news emerges that the Transitional Measures Task Force has issued a Q&A paper, the first document to be issued by this group charged with facilitating the EU regulatory overhaul, Medtech Insight explains the different roles of the TMTF and some other key organizations involved in MDR/IVDR implementation.

Europe Regulation

New Recall Procedures For Australian Therapeutic Goods Come Into Play

As of Jan. 15, sponsors of therapeutic goods in Australia must follow new recall procedures, which have been updated to ensure they are consistent with current regulatory best practice.

Recalls Regulation

QUOTED. Jan. 15, 2018. Oliver Bisazza.

Check out what MedTech Europe's Oliver Bisazza had to say about how long it will take for notified bodies to become approved under the EU's Medical Device and IVD Regulations.
Quoted Europe
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Quality Control & Compliance

Set Alert for Quality Control

Compliance Corner: Suppliers Can Wreak Havoc On Process Validation Outcomes. Here Are 4 Ways To Keep Them In Check

Having a stellar supplier qualification program in place can lessen the variability in a device-maker's validated processes, says industry expert (and former FDAer) Ricki Chase. She notes that using tools such as questionnaires and onsite audits to determine the suitability of vendors, as well as requalifying and monitoring suppliers of components and services, is essential. "Suppliers can affect your validation activities. Suppliers can completely destroy everything you've put a lot of hard work into," Chase says.

Compliance Quality Control Compliance Corner

Latest From Quality Control

BD Handed US FDA Warning Letter In Lead-Test Investigation

The agency letter cites quality systems, Medical Device Reporting and device clearance concerns. It stems from an ongoing investigation into lead tests distributed by Magellan Biosciences that sometimes give faulty results.

Quality Control Regulation

Compliance Corner: When Should Your Firm Revalidate Under Process Validation? An Expert Explains

Conducting process validation activities isn't a one-and-done deal for device-makers; rather, they must revalidate manufacturing processes from time to time, and when necessary. QA/RA expert Mark Durivage highlights an array of situations that could trigger the need for revalidations.

Compliance Quality Control

9 Device-Makers Wanted For US FDA Pilot Program To Measure Quality System Maturity

US FDA is looking for nine medical device firms to enroll in its Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program, which will use third-party Capability Maturity Model Integration (CMMI) appraisers to evaluate a company's quality system maturity as a view into whether it is operating above a compliance baseline.

Quality Control Compliance

Machine Vision’s Promise For Medical Device Quality

Sure, the human eye is amazing, but there could be problems if it must inspect hundreds of manufactured parts per minute. So, just short of hiring the Six Million Dollar Man or Bionic Woman, what can device-makers do to ensure that all parts are of the best quality? It all starts with machine vision, say Vantage Consulting Group's Vito Pirrera and John Jordon in this guest column.

Manufacturing Quality Control

FDA Asks For More Summary Adverse Event Reports Under Proposed MDR Program

The US agency has proposed a Voluntary Malfunction Summary Reporting Program that will allow makers of an array of devices to submit Medical Device Reports in a summary, rather than individual, format to FDA. The program aims to make the MDR-reporting process more effective and give the agency clearer post-market visibility.

Safety Quality Control

Compliance Corner: 5 Key Steps To Reassessing Management Reviews At Your Firm

Abbott Laboratories' quality VP, Monica Wilkins, outlines five steps that device-makers should take when reevaluating their management review process to make sure they get the most out of the meetings.

Compliance Quality Control
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Policy

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Latest From Policy

MRI And Cardiac-Rhythm Devices: A Match Made In Medicare

A proposed coverage policy from the US Centers of Medicare and Medicaid Services would not only cover magnetic resonance imaging for patients with an implanted cardiac rhythm management device with an FDA-approved indication for MRI-compatibility, but will also cover MRI in patients with devices without that FDA labeling in certain circumstances.

United States Clinical Trials

New EU Task Force Finalizes First Document

As news emerges that the Transitional Measures Task Force has issued a Q&A paper, the first document to be issued by this group charged with facilitating the EU regulatory overhaul, Medtech Insight explains the different roles of the TMTF and some other key organizations involved in MDR/IVDR implementation.

Europe Regulation

Lingering Debt And New E-Procurement System Await Turkish Medtech

2017 saw developments that were beneficial to the Turkish medtech industry, like the continued progress of the billion-dollar City Hospitals project, but also initiatives such as forthcoming Online Health System Market that will have a mixed impact on industry players. Additionally, the year also saw medtech suppliers increasingly frustrated by the growing debt that is owed to them by Turkey's hospitals, an issue that remains unresolved. This article give an overview of the Turkish medtech market in 2017 and developments to look out for this year.

Turkey Market Access

QUOTED. Jan. 15, 2018. Oliver Bisazza.

Check out what MedTech Europe's Oliver Bisazza had to say about how long it will take for notified bodies to become approved under the EU's Medical Device and IVD Regulations.
Quoted Europe

'Intended-Use' Rule Delayed Indefinitely By US FDA

A controversial change that could have broadened the definition of "intended use" to include almost anything discussed in manufacturer communications has been delayed indefinitely as FDA reopens the comment period.

Medical Device Policy

EU Regulation Creates New Basis For Environmentalists To Exert Pressure On Medtech

The medtech industry has to address new environmental requirements within the EU's new Medical Devices Regulation. While lack of new government structures could delay full compliance, those who snooze may lose.

Europe Medical Device
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