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Policy & Regulation

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21st Century Cures Implementation: Device Provision Updates

Dozens of reforms impacting the medtech sector were signed into law Dec. 13, 2016, in the 21st Century Cures Act. Here's a breakdown of where things stand in the implementation of key provisions.

Policy Legislation FDA

Australia’s TGA Overrides Industry Concerns Over Publishing Priority-Review Pathway Decisions

Australia’s Therapeutic Goods Administration published a summary of changes it made to its coming priority-review pathway, following a public consultation on the initiative.

Review Pathway Australia Policy & Regulation
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Regulation

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As Device Firms Take Costa Rica By Storm, Quality Control Experts Champion 'Pura Vida'

"Pura Vida" – a Spanish phrase meaning the "pure" or "simple life" – isn't just the unofficial motto of Costa Rica; rather, it's a state of mind, locals say. But as more and more medical device manufacturing facilities pop up in the tiny Central American nation, quality assurance professionals there have discovered that ensuring top-notch product quality doesn't necessarily make life simpler. To jump that hurdle, QA experts from a variety of firms – including Medtronic, Precision Concepts and Creganna Medical – have banded together to lean on each other as they search for solutions to quality systems issues, as well as knowledgeable input on hot quality and compliance topics.

Quality Control Compliance Costa Rica

Latest From Regulation

Q&A: FDA Dx Reviewer's Tips For Next-Gen Sequencing Sponsors

A top reviewer in US FDA's in vitro diagnostics office offers tips to next-generation sequencing test sponsors to avoid common submission shortcomings in this interview with Medtech Insight. According to FDA's Hisani Madison, sponsors frequently fall short in providing a refined intended-use statement.

In Vitro Diagnostics Personalized Medicine

Warning Letter Roundup & Recap – June 20, 2017

US FDA did not release any device-related warning letters the week of June 20.

Device Warning Letters Medical Device

South African Medtech Reg: Pieces Coming Together, As August Deadline Approaches

South African medtech firms have been given until August 24 to license their business establishments and list (but not actually register) their products. There is controversy over the fees and a growing list of tasks for industry and the government, but the key pieces generally seeming to be falling into place to support standing up a South African medtech regulatory system.

South Africa Regulation

US FDA Updates Clinical Trial e-Reporting, e-Signature Guidance To Keep Up With Tech

In a draft guidance on electronic signature and record requirements for clinical trials used to submit applications across FDA product centers, the agency responds to technological advances since it last issued guidelines almost 15 years ago, while keeping its narrow enforcement of the "Part 11" rules in place.

Regulation Clinical Trials

Medtech Summit: The Three Biggest Challenges Of The EU MDR

The EU's Medical Devices Regulation has entered into force, but there is still three years until it is fully applicable. Already there is a tidal wave of questions about some of the most critical elements. Will they be answered in time?

Europe Medical Device

South Africa Medtech Reg: As New System Nears Finish Line, Device-Drug Distinctions Still Need Highlighting

Stakeholders pushing for a dedicated medtech regulatory system in South Africa have been in sight of the finish line on several occasions in recent years, only for obstacles to rise. But a new structure is almost in place with the enactment of key rules this month. The country's device industry group, meanwhile, is still working to ensure the government fully appreciates important distinctions between devices and drugs.

South Africa Regulation
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Quality Control & Compliance

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Compliance Corner: US FDA Wants Device Firms To Fully Consider Risks To Consumers, Agency Expert Says

Manufacturers that don't consider all possible dangers their products can pose to consumers is a growing problem, FDA's national expert on devices says. Phil Pontikos also is worried that firms aren't putting their best foot forward when using risk assessment tools.

Risk Management Compliance Quality Control

Latest From Quality Control

Compliance Corner: Keep 'ALCOA' In Mind To Ensure Quality Data Integrity, Says US FDA Expert

When inspecting a device manufacturing facility, FDA investigators will check a company's quality data to make sure it's Attributable, Legible, Contemporaneous, Original and Accurate – or "ALCOA," the agency's national device expert says.

Quality Control Compliance

Zimmer Biomet Resolves Chinese Plant Warning Letter

The warning letter referred to CAPA and quality assurance issues at a surgical instruments manufacturing plant in China.

Quality Control Orthopedics

Class I Device-Makers Get Wiggle Room As US FDA Pushes UDI Compliance Date To 2020

Manufacturers of low-risk class I products were given an extra two years to comply with FDA's Unique Device Identification requirements to give the agency and industry time to work through challenges posed by incorporating device identifiers into electronic health systems.

Quality Control Compliance

Compliance 360° Part 9: US FDA Is Looking Closely At Process Validation – Are You Ready?

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this ninth installment, we interview former FDA investigations branch director Ricki Chase, who explains why your device firm needs to be on the ball when it comes to process validation activities and offers tips for best practices.

Quality Control Compliance

Gifts For Industry: From Waived Inspections To Pre-Market Leeway, US FDA Woos Firms For Maturity Pilot

FDA wants to give away a basket of goodies to manufacturers that voluntarily play in an upcoming pilot program that will help the agency determine the manufacturing maturity of device-makers by using the CMMI maturity model appraisal process. Incentives to join the pilot include FDA delaying regularly scheduled facility audits, waiving preapproval inspections, allowing more leeway for 30-day notices and pre-market submissions, and easing up on the issuance of FDA warning letters. A major goal of the initiative is for the agency to have greater confidence in firms that demonstrate high-quality, gold-star quality systems so it can focus its limited resources on less mature, troublesome firms.

Quality Control Compliance

Q1 Recalls Snapshot: Recalled Device Units Drop To Lowest Level Since 2013; Recall Events Dip Slightly

There were 284 recall events from January through March, down 9% from Q4 2016's 313 corrections and removals. Check out our Q1 recalls infographic.

Recalls Quality Control
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Policy

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Latest From Policy

US Trade Rep May Take Enforcement Actions Against India Over Device Price Controls

US Trade Representative Robert Lighthizer told Senate Finance Committee Chairman Orrin Hatch, R-Utah, that if India's ongoing practices to impose price controls on US device imports continue, he would consider "enforcement actions," if India's actions violated any World Trade Organization trading rules.

Cardiology Trade

Device Lobbyists Support Device Tax Repeal in Senate Health Bill, As Providers Remain Opposed

AdvaMed members ratcheted up pressure on members of Congress last week to permanently abolish the device tax, be it in the Senate Affordable Care Act repeal bill, or any other way they can get it. Meanwhile, medical provider groups, including the American Medical Association, American Heart Association, and the American Hospital Association, are lobbying against the Senate's bill to prevent insurance coverage losses.

Policy Legislation

Device Week – June 16, 2017

On this week's Medtech Insight podcast: expect digital health guidance documents from US FDA soon, the agency’s commissioner says; FDA optimistic it will push out a final version of a 3D printing manufacturing guidance this year; US government releases data on the number of people who would lose health insurance under the American Health Care Act; Wells Fargo report fingers which device types would be most impacted by Trumpcare; a look at FDA approval and clearance trends, including a noticeable increase in 510(k)s; new clinical data releases discussed.

FDA Digital Health

ACA Repeal: A Look At Device Procedure Impacts

A select group of legislators are working behind closed doors on a Senate bill to repeal the Affordable Care Act. It's not yet clear how close or far apart it will be from the House American Health Care Act, but here is a graphical look at what the AHCA might mean for device procedure volumes.

Policy Legislation

German Medtechs Aim To Score Useful Points In 2017 Election Year

The 2017 German national election, set for September 24, is not only a chance for Angela Merkel to secure a fourth term in office as Chancellor, but also an opportunity for the medtech industry to tell lawmakers how they can make the health-care system better. The medtech industry has made ten demands of the new government, with recent opinion polls favoring the status quo.

Germany Medical Device

US Congress 'May' Finish Diagnostic Regulatory Reforms By End Of 2017, Rep. Burgess Says

Congress may complete work they started in March on the 'Diagnostic Accuracy and Innovation Act' by the end of this legislative year, Rep. Michael Burgess, R-Texas, said. But if not, almost certainly it will be addressed by the end of 2018, before the 115th Congress adjourns.

In Vitro Diagnostics Policy
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