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Policy & Regulation

Set Alert for Policy & Regulation

FDA Looks For Diverse CMMI 'Maturity' Pilot Enrollees; Device-Makers Expect Big Savings

The US agency is looking for ways to open its upcoming Voluntary Medical Device Manufacturing and Product Quality Program – designed to gauge the manufacturing maturity of device-makers – to smaller firms, officials said at a recent industry meeting. Medtronic and Edwards Lifesciences, in particular, noted that using the Capability Maturity Model Integration (CMMI) appraisal framework could allow them to save hundreds of thousands of dollars in FDA submissions and 30-day notice fees, among other expenses.

Quality Control Compliance Quality

US Approvals Analysis: Cook Churns Out 510(k)s In Q3

The privately held Indiana-based device firm has accelerated its 510(k)-clearance output this year, leading all firms with 19 in the third quarter, and pulling neck-and-neck with perennial leader Medtronic for 2017. Overall, FDA remains relatively steady on 510(k) volumes and is maintaining its accelerated pace of novel-device approvals.

Approvals Innovation Research & Development
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Regulation

Set Alert for Regulation

Warning Letter Roundup & Recap – Oct. 17, 2017

US FDA issued two device-related warning letters this week detailing quality systems issues at a dialysis supply manufacturer and a facial prosthetics company.

Device Warning Letters Regulation Medical Device

Latest From Regulation

Latest On EU's MDR/IVDR Implementation Road Map

October 19 came and went without release of the EU's official road map, which will act as a catalyst for work intended to support implementation of the new EU medtech regulations. So how much longer before it is public?

Medical Device Europe

FDA Final Guidance On Drug/Device Classifications Misses The Mark, Attorneys Say

The final guidance adds some requested clarifications, but does not appear to address the US agency's tendency to designate products as drugs over devices, industry attorneys argue.

Regulation Combination Products

Why Low-Risk And Upclassified Devices Must Heed EU Timeline Warnings

EU compliance deadlines for low-risk devices may be earlier than companies realize. Meanwhile, deadlines for device-types that are being upclassified under the new regulations may mean time pressures, too, for different reasons. Notified body VP Bassil Akra explains in an interview with Medtech Insight.

Europe Medical Device

EU Commission May Open Floodgates By Inviting Input On Editorial Errors

The European Commission is planning to invite comments on editorial mistakes within the EU's new medtech regulations. But will it get more than it is bargaining for?

Europe Medical Device

Crucial EU Meeting Oct. 18 To Set Out MDR/IVDR Implementation Work

Implementation of the EU's new highly-detailed Medical Device and IVD Regulations will greatly challenge EU regulatory groups. The work plan signposts the direction ahead, but it will be resource-hungry.

Medical Device Europe

FDA Calling: US Agency Again Asks Companies To Open Doors For Educational Purposes

In its continuing bid to better understand how industry and other stakeholders operate in the real world and learn to improve its own practices, FDA is again asking volunteers to let staffers come observe organizations for a day or two as part of the device center's Experiential Learning Program.

Regulation FDA
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Quality Control & Compliance

Set Alert for Quality Control

Many Firms Use Old-Fashioned Complaint Handling Tactics, Survey Finds

A recent study by Sparta Systems revealed that more than four in 10 companies, including device-makers, still primarily handle customer complaints on paper, or via a decentralized system like Microsoft Excel or Access. Two quality assurance experts weigh in.

Quality Control Compliance Quality

Latest From Quality Control

'Super Office' To The Rescue: FDA's Device Center Is About To Undergo A 'Total Product Life Cycle' Makeover

CDRH Director Jeff Shuren told industry that the device center is moving quickly to establish a "super office" to tackle the full spectrum of pre- and post-market issues to reduce inefficiencies to replace the more siloed approach. Chief Scientist Bill Maisel has already been named a director.

Regulation FDA

Quality On The Brain: FDA Maturity Pilot Aims To Shift Industry's Compliance Mentality To A 'Quality Mindset'

An upcoming voluntary pilot program from US FDA will be the perfect vehicle to help drive a compliance-to-quality culture change at medical device firms, developers of the program say. To be stood up early next year, the pilot will see manufacturers use third-party assessors to measure the maturity of their quality systems and manufacturing processes. In a survey, early users of the Capability Maturity Model Integration (CMMI) appraisal process said it helped them identify ways to increase product quality.

Quality Control Compliance

Tossed Aside? Millennials More Likely To Ignore, Throw Out Product Recall Notices, Survey Finds

The survey of more than a thousand consumers shows that manufacturers might want to change the way they interact with people between the ages of 18 and 34 when communicating information about device recalls.

Recalls Quality Control

Compliance Corner: Abbott Quality VP Wants You To Talk About These 5 Things At Management Reviews

Monica Wilkins, divisional VP of medical, quality and strategic support for device-maker Abbott Laboratories, returns to Compliance Corner with more tips for management reviews. This time, she pinpoints five things that manufacturers should discuss during the meetings.

Quality Control Compliance

Device-Makers Can Forego US FDA Pre-Approval Inspections By Joining New 'Critical-To-Quality' PMA Pilot

Nine manufacturers will be selected to play in the agency's voluntary "Premarket Approval Application Critical to Quality" (PMA CtQ) pilot program. Participants will "discuss device design and manufacturing process quality information with FDA early on" to assist "in its review of the PMA manufacturing section and post-approval inspections," the agency says in a notice set to publish in the Sept. 12 Federal Register.

Quality Control Compliance

US FDA Inspections & FDARA: Will New Law Light The Way For Investigators? Maybe, Experts Say

The FDA Reauthorization Act, enacted last month, includes provisions that aim to improve FDA's inspection process, including putting a stop to arbitrary audit scheduling by the agency – a practice that can cause a facility inspection to drag on for weeks at a time. FDA has until early 2019 to draft a guidance document that lays out how it will ensure a more uniform inspection process that ensures greater parity between foreign and domestic audits. Steps mandated by the new law include notifying firms in advance of records that will be requested during an inspection and specifying a window of time for investigators to conduct the onsite inspections. But industry experts are of two minds as to whether any substantial changes will result from the new law. Also: FDA device center Director Jeff Shuren weighs in.

Quality Control Compliance
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Policy

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Latest From Policy

Industry Asks CMS To Allow More Medtech Input, Longer-Term Metrics In Bundled Pay Models

Industry groups told the US Medicare agency it should seek the input of a broader array of stakeholders – including medtech companies – in developing future episode-of-care pay models. They also argued that participation in the programs should be voluntary, and that the pay models should account for patient outcomes longer than 90 days following initial care. The responses came in comments to CMS following its proposal to scale back its joint replacement bundled payments program and eliminate a cardiac-care version.

Reimbursement Market Access

Latest On EU's MDR/IVDR Implementation Road Map

October 19 came and went without release of the EU's official road map, which will act as a catalyst for work intended to support implementation of the new EU medtech regulations. So how much longer before it is public?

Medical Device Europe

Minnesota Lobby Group Hires Top State House Staffer

The Medical Alley Association hired the former Minnesota House Speaker's legislative director Bobby Patrick to lead lobbying efforts in the state.

Policy Medical Device

Why Low-Risk And Upclassified Devices Must Heed EU Timeline Warnings

EU compliance deadlines for low-risk devices may be earlier than companies realize. Meanwhile, deadlines for device-types that are being upclassified under the new regulations may mean time pressures, too, for different reasons. Notified body VP Bassil Akra explains in an interview with Medtech Insight.

Europe Medical Device

AdvaMed CEO Supports Potential HHS Secretary Nominee Azar

AdvaMed CEO Scott Whitaker says Alex Azar, who is reportedly the top candidate to be nominee for US Health and Human Services secretary, would be ideal for the job with his extensive experience at the department.

Policy Medical Device

EU Commission May Open Floodgates By Inviting Input On Editorial Errors

The European Commission is planning to invite comments on editorial mistakes within the EU's new medtech regulations. But will it get more than it is bargaining for?

Europe Medical Device
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