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Policy & Regulation

Set Alert for Policy & Regulation

'Program Alignment' Turns 1: FDA Wants To Train Investigators On Innovative Tech As Part Of Its Inspection Scheme – But Will It Be A Cakewalk?

At the one-year anniversary of "program alignment" – US FDA's ambitious reorganization of its inspectional body – the agency is pushing hard to train its investigators on an array of medtech products. In that spirit, FDA has asked manufacturers to willingly open their doors to its investigators so they can learn more about the type of devices the firms are making, says Blake Bevill, a program division director for program alignment. Industry group AdvaMed and health-care organization Medical Alley Association are also getting in on the action by helping investigators learn about an array of topics, including software, electrical engineering, validation and design.

FDA Enforcement Compliance

Labs, Test Makers Urge Congress To Pass Diagnostic Reforms

More than 80 industry, laboratory, health-care provider and patient groups sent a letter to two congressional committees, urging them to advance a bill to modernize the current way FDA regulates diagnostic tests, including possibly a new regulated product category that combines laboratory developed tests and in vitro diagnostics.

In Vitro Diagnostics Legislation Regulation
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Regulation

Set Alert for Regulation

UPDATED: 10 Things You Need To Know About FDA's 'Program Alignment' Inspectional Reorg

Now that US FDA's "program alignment" inspection paradigm is in full swing, does your device firm know where to send an FDA-483 response? How to alert the agency about a recall? Who to contact if there is a problem with an FDA investigator? If not, then check out the answers to those questions – and seven more – in this updated feature article.

FDA Enforcement Compliance

Latest From Regulation

Concerns Rise For Notified Bodies Over Potential Reopening Of PIP Case

Medtech notified bodies need to monitor PIP liability issues again as France's top court weighs in. Will it trigger a reopening of the TÜV Rheinland liability case? And what might it mean for notified bodies in general?

Europe Legal Issues

FDA Urges Caution in Some Neurovascular Stent Use

US FDA has issued new guidelines to providers because some patients experienced strokes or died after being treated for unruptured brain aneurysms with some neurovascular stents.

Medical Device Neurology

New Dutch Chair For Pivotal EU Medtech Authority Group

The new executive group chair of the Competent Authorities for Medical Devices will help steer EU medtech through one of the trickiest times in its regulatory history, as the key national authorities group loses its UK lead.

Medical Device Europe

Warning Letter Roundup & Recap – May 17, 2018

German maker of the Twion Power Push-Rim Power Drive System cited for quality systems violations; RADLogics was marketing its AlphaPoint software without pre-market approval or clearance from US FDA.

Device Warning Letters FDA

QUOTED. May 17, 2018. Renzo Marchini & Robert Fett.

The May 25 deadline for the EU's General Data Protection Regulation is rapidly approaching. See what attorneys Renzo Marchini and Robert Fett have to say about some of the considerations for medtech companies.

Cybersecurity Digital Health

No New Regulations Needed For Third-Party Servicers Of Devices, FDA Says

There is “not sufficient evidence” of a widespread public health concern relating to servicing of devices, including by third-parties, according to an FDA report; the agency sees no immediate needs to issue new regulatory requirements for the third-party servicers. The agency also intends to issue guidance to help clarify the difference between “servicing” and “remanufacturing."

Diagnostic Imaging Quality
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Quality Control & Compliance

Set Alert for Quality Control

US FDA Commissioner: Agency Will Propose New Rule That Blends Quality System Regulation, ISO 13485

Scott Gottlieb wrote in a May 9 blog post that the agency will propose a new rule that will blend its Quality System Regulation with international quality systems standard ISO 13485. Gottlieb claims the new rule would "harmonize domestic and international requirements, and modernize the regulation," while making sure that device-makers "adhere to high, internationally accepted quality systems."

FDA Quality Control Standards

Latest From Quality Control

Device Week, May 18, 2018 – Medtech’s Next Top Maturity Model, Part 1

On this week's podcast, Shawn M. Schmitt talks about his first story in a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry. An ongoing US FDA pilot program – which uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method – is discussed.

Device Week Quality Control

US FDA Finds Ongoing CAPA Issues In Zimmer Plant Reinspection

A follow-up inspection evaluating Zimmer Biomet’s progress in remediating issues documented in a 2016 FDA Form-483 uncovered 11 observations, eight of them repeats.

Quality Control Orthopedics

Q1 Recalls Snapshot: Recalled Units Skyrocket 457%; Largest Quarterly Number In 13 Years

More medical devices were recalled by manufacturers in the first quarter of 2018 than in any quarter since at least 2005, with 343 initiated. Moreover, there were 208.4 million units recalled in Q1 '18 – more units than in all of 2017. Check out our Q1 recalls infographic.

Recalls Safety

NSF's Trautman Talks MDSAP, Swapping FDA's QSR For ISO 13485, Regulatory Convergence, EU's MDR & IVDR, And More

Former longtime US FDA official Kim Trautman, now with NSF International, sat down with Medtech Insight at MedCon 2018 for a podcast interview to discuss an array of industry issues, including the burgeoning Medical Device Single Audit Program, international regulatory convergence, FDA's percolating plan to replace the Quality System Regulation with ISO 13485, what keeps her up at night (hint: it's EU's new Medical Device and IVD Regulations), and other important issues that device-makers need to keep a sharp eye on.

Quality Control Compliance

Device-Makers Like Baxter Are Lining Up To Let CMMI Evaluate Their Manufacturing Site Capabilities. Here's What To Expect If You're Appraised

Baxter Healthcare's Elizabeth Zybczynski was excited when she first heard that her company would join a US FDA pilot program to measure the capability and maturity of medical device manufacturing sites. Having worked in the aerospace and defense industries before moving to the health-care arena, Zybczynski knew that the tried-and-true Capability Maturity Model Integration (CMMI) approach could elevate quality in the device industry. CMMI Institute's Kimberly Kaplan and CMMI appraisers Becky Fitzgerald and George Zack explain the maturity model process that Baxter – and 13 other manufacturers – have gone through, from initial intake phone calls to the unveiling of final appraisal results.

The second of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.

Quality Control FDA

Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites

The pursuit of quality can be a daunting task for device-makers. One wrong step can cause costly product recalls affecting patient health – among other troubles tied to poor quality products and processes. To help firms move toward a goal of best-in-industry quality, US FDA, through its Case for Quality initiative, has convened a pilot program to measure a manufacturer's capability and maturity to help put it on a path to continuous improvement. The pilot uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method, developed jointly by FDA, industry and CMMI Institute.

The first of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.

Quality Control FDA
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Policy

Set Alert for Policy

Latest From Policy

Bills Supporting Device Opioid Alternatives Advance In House

The House Energy and Commerce Committee approved four opioid crisis-related bills that call for US FDA meetings and consideration of streamlined pathways for medtech alternatives to opioids, and for a report and action by the US Medicare agency on overcoming payment challenges to device pain control products.

Legislation Policy

Concerns Rise For Notified Bodies Over Potential Reopening Of PIP Case

Medtech notified bodies need to monitor PIP liability issues again as France's top court weighs in. Will it trigger a reopening of the TÜV Rheinland liability case? And what might it mean for notified bodies in general?

Europe Legal Issues

New Dutch Chair For Pivotal EU Medtech Authority Group

The new executive group chair of the Competent Authorities for Medical Devices will help steer EU medtech through one of the trickiest times in its regulatory history, as the key national authorities group loses its UK lead.

Medical Device Europe

Industry Gives US Trade Rep 12 Reasons Why Tariffs on Chinese Medtech Imports Are A Bad Idea

The US Trade Representative office's decision in March to include devices, imaging machines and diagnostics on a list of Chinese imports destined for a 25% tariff has riled up the industry. A half-dozen medtech organizations protested the move in comments and testimony this week, supplying USTR with 12 reasons why the tariffs are a very bad idea.

Trade Policy

Watchdog OKs Ostomy Company Samples

An ostomy supply manufacturer can give free samples to potential clients without violating anti-kickback rules, the US Department of Health & Human Services’ Office of the Inspector General wrote in a recent advisory opinion.

United States Enforcement

QUOTED. May 11, 2018. Martha Shadan.

New AdvaMed Accel Chair Martha Shadan is also a founding member of the Women's Executive Network (WEN), which aims to help women reach executive positions in the medtech industry. See what she said about her own experience of being a woman in industry here.

Quoted Policy
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