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Policy & Regulation

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Gastric Balloon-Makers Respond To US FDA Warning

Apollo Endosurgery and Reshape Medical are both defending their products’ safety in the wake of a US FDA letter warning of five deaths tied to the companies' intragastric balloon devices.

Medical Device Gastroenterology Safety

Ukraine Medtech At Last Crosses From State To DoC Regulatory System

Ukraine's EU-aligned medtech regulatory system, using notified bodies and manufacturers' Declarations of Conformity (DoC), came into effect on July 1. The state retains a role in surveillance, but it no longer controls medtech registration; companies must now comply with three technical regulations (akin to the EU medical device directives) to access the medtech market in Ukraine.

Ukraine Regulation Medical Device
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Regulation

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Health Reform Roundtable Members Hold Conflicting Views On Device Tax Repeal For ACA Reform

A group of high-level health policy analysts – including former Medicare and Medicaid officials and experts at policy groups including Families USA and the American Enterprise Institute – have crafted a bipartisan recommendation for Affordable Care Act reform, but are divided on if the 2.3% device excise tax created by ACA should be repealed.

Policy Legislation United States

Latest From Regulation

US FDA Updates List of Recognized Medtech Standards With 49 New Entries

The US Food and Drug Administration has included 49 new standards and made several other changes to its list of recognized medtech standards. The list is a useful reference for manufacturers, who choose to declare conformity with consensus standards to meet certain requirements for medical devices and IVDs, including to help support pre-market submissions.

Regulation US States

Exec: EU May Lose Out On More Innovation As MDR Pressure On NBs Begins To Bite

The new MDR and IVDR were drafted with highest interests of EU patients in mind, but they may yet have a devastating effect on the EU's speedy access to innovation in general, and on medtech SMEs in particular. That is the view of one Swiss medtech CEO; he also has grave concerns about the loss of EU notified bodies and the impact on manufacturers.

EU Regulation

US FDA: BD Didn’t Act On Faulty Lead Test Warning

An FDA-483 released as part of an ongoing probe into Magellen’s faulty LeadCare tests found GMP and MDR violations at a BD plant where some test-tube components used with the tests were manufactured.

Medical Device Diagnostics

Cook Removes Indication, Pulls Sizes From Market Following Graft Recall

Cook Medical is pulling certain sizes of its Zenith Alpha thoracic endovascular graft from the market due to reports blood clots and occlusions may form inside the graft when it’s used to treat blunt traumatic aortic injury.

Medical Device Recalls

Expanding The Medtech Toolbox: US FDA's 'Medical Device Development Tools' Program Rolls Out

Three years in the making, FDA has released a final guidance for medical device development tools that would allow developers to qualify their MDDTs and give medical device manufactures access to new tools that could help them prove safety and effectiveness of their products sooner.

Regulation Clinical Trials

PMA Supplement Studies Weak, Study Finds, As Past FDA Chief Califf Calls For More Rigor

The quality of studies used to support panel-track PMA supplement approvals need upgrading, as fewer than half were randomized, blinded or controlled and many relied on surrogate endpoints, says a study published in JAMA. In an accompanying editorial, former FDA commissioner Robert Califf, says it "raises concerns" that the US regulatory system has gotten "too permissive."

Clinical Trials Regulation
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Quality Control & Compliance

Set Alert for Quality Control

Quality Replay: FDA Urges Firms To Close Loop On CAPAs, Create Filters To Weed Out Poor Quality Data

From our digital archives: Applying a closed-loop approach to corrective and preventive action activities is one of the best ways to ensure device quality and gather useful data, US FDA says. Manufacturers often fail to ensure that they complete the CAPA loop, leading to corrective and preventive actions that might be open for years, or product fixes that don’t work and complicate matters further by presenting the firms with a whole new set of challenges.

Quality Control Compliance Quality

Latest From Quality Control

Quality Replay: Device History Record ‘Oversights’ A Clear Path To Quality Troubles, FDA Says

From our digital archives: Manufacturers are overlooking various key elements that should be included in device history records, including up-to-date labels, dates of product manufacture and missing signatures on documents, US FDA says. Because DHRs touch virtually every part of a firm’s quality system, a flawed DHR can prompt agency investigators to dig deeper during inspections. Experts from device firms Baxter and Thoratec weigh in.

Quality Control Compliance

Q2 Recalls Snapshot: Dramatic Increase In Class I Actions; Overall Recalls Dip Slightly

The number of high-risk class I recalls ballooned 88% in the second quarter of 2017. Overall, recalls fell 3%. Check out our Q2 recalls infographic.

Recalls Quality Control

'A Sea Change': Device Center Compliance Chief Touts US FDA's Benefit-Risk Concepts – But Will Manufacturers Buy In?

FDA compliance head Robin Newman is asking manufacturers to share information on troublesome devices to help the agency make benefit-risk decisions that weigh product availability and regulatory compliance. But an industry survey finds that only 17% of firms are willing to hand over such potentially sensitive information. Nevertheless, the agency believes it's vitally important for device-makers to be more forthcoming with data that supports well-informed benefit-risk conclusions, made in the best interest of patients and manufacturers. Driving the data-sharing discussion is a December guidance from FDA that outlines a broad framework for considering benefit-risk factors – a document that Newman says is "a sea change" for how industry and the agency can work hand-in-hand on benefit-risk analyses.

Quality Control Compliance

Compliance Corner: There Are 7 Reasons Why You're Screwing Up Management Reviews, Abbott Quality VP Says

Monica Wilkins, divisional VP of medical, quality and strategic support for device-maker Abbott Laboratories, lays out seven distinct issues that can keep manufacturers from getting the most out of management review meetings.

Quality Control Compliance

US FDA Maturity Model Pilot Program Gets October Meeting Date

The agency wants to hear public feedback on its plan to employ a standardized model to measure a company's manufacturing "maturity" via third-party assessments to support regulatory and compliance decisions.

Quality Control Compliance

Compliance Corner: 6 Tips From US FDA To Ensure Robust Software Validation

Device manufacturers can avoid headaches during agency inspections by following this advice from two FDA investigators.

Quality Control Compliance
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Policy

Set Alert for Policy

Latest From Policy

MDUFA IV (And More) Is Law: Trump Signs A Health-Care Bill

President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.

Policy Legislation

Patrick Conway Departs CMS As It Diverges From His Vision

Conway, a champion of the US agency's move into value-based care, will take the helm at Blue Cross/Blue Shield of North Carolina.

Policy Medical Device

Could CMS Changes To Bundled Pay Models Stifle Medtechs' Value-Based Pay Plans?

The US Center for Medicare and Medicaid Services proposed downsizing its CJR joint replacement value-based payment model and outright canceling its cardiac procedure bundled payment model. Will the move discourage companies like Zimmer Biomet, Johnson & Johnson, and Medtronic, which have already invested in programs based on the value-based models?

Reimbursement Market Access

Senator Introduces Medical Device Cybersecurity Act

Sen. Richard Blumenthal, D-Conn., recently introduced legislation that would enhance medical device security by generating a "cyber report card" for medtech products and securing more remote access protections for devices in hospitals. S. 1656 draws on advice in a June 2 HHS white paper on improving cybersecurity in the health-care industry.

Cybersecurity Policy

US House 'Problem Solvers,' AdvaMed, Aim To Repeal Device Tax

Two recent efforts to repeal the medical device tax include proposed legislation by a bipartisan "Problem Solvers" group of House members that includes a device-tax repeal provision, as well as an advertising campaign by AdvaMed.

Policy Legislation

'It's Time': AdvaMed Device Tax Ad Campaign Sets Sights On Key Lawmakers

While lawmakers are back in their districts during Congress' recess, AdvaMed is running local ads aimed at major congressional leaders to ensure they continue to prioritize repealing the 2.3% medical device excise tax.

Legislation Business Strategies
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