Search Results for medical device

Showing 1 – 25  of 500

A New Regulatory Paradigm for Medical Devices in India By Dushyant Kumar, MPharm, RAC, Vibhu Yadav, MPharm, Nancy Mathewson, Esq - Published 12 December 2017

This article explains medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes.

Categories: Features, India, GHTF, IMDRF, ISO, Medical Devices

Tags: Draft Medical Device Rules 2017, GHTF, Bureau of Indian Standards, BIS

The Medical Device Coordination Group: a new Authority Under EU Device Regulations By Robert D. Cumming, Nancy W. Mathewson, Esq. - Published 14 November 2017

This article discusses the organization and functions of the Medical Device Coordination Group (MDCG) established under the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The article explains how both groups will be important players in the conformity assessment body 'notification' process and in determining how notified bodies assess and certify devices and in serving as a reviewing body for making regulatory and jurisdictional decisions for the European Commission.

Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices

Tags: MDR, IVDR, Medical Device Coordination Group, MDCG

Journal Editors Should Encourage Disclosures of CDRH's Role in Trial Designs: JAMA Viewpoint By Zachary Brennan - Published 07 November 2017

Journal editors should encourage research authors to disclose the role of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) in clinical trial design and execution, Aaron Kaplan of the Heart & Vascular Center at Dartmouth-Hitchcock Medical Center and Ariel Stern of Harvard Business School, wrote in a JAMA viewpoint.

Categories: News, US, CDRH, Government affairs, Medical Devices

Tags: medical device clinical trials,

Reps Question Gottlieb on Bayer's Follow-Up Essure Studies By Zachary Brennan - Published 31 October 2017

Reps. Rosa DeLauro (D-CT), Jan Schakowsky (D-IL) and Louise Slaughter (D-NY) on Monday sent a letter to FDA Commissioner Scott Gottlieb regarding concerns related to Bayer's postmarket study for its permanent birth control device Essure.

Categories: News, US, FDA, Compliance, Medical Devices, Postmarket surveillance

Tags: Essure, Bayer, Gottlieb, medical device safety

MDSAP Changes Aim to Reduce Audit Times By Zachary Brennan - Published 30 October 2017

With an eye on a 1 January 2019 deadline for transitioning to only Medical Device Single Audit Program (MDSAP) quality management system certificates accepted for medical device license applications by Health Canada, the MDSAP consortium has implemented a couple of changes to speed up audits.

Categories: News, Canada, Health Canada, IMDRF, Government affairs, In vitro diagnostics, Medical Devices, Quality

Tags: MDSAP, quality management system audits, medical device audits

First Implementing Act Under EU MDR, IVDR Open for Consultation By Zachary Brennan - Published 20 October 2017

The first implementing act for the EU’s new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) is open for comments until next Wednesday.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices

Tags: MDR, IVDR, medical device regulations Europe

Health Canada Seeks to Update User Fees for Drug and Device Firms By Zachary Brennan - Published 13 October 2017

Health Canada this week opened for consultation a proposal to update and increase some of the fees it assesses for pharmaceutical and medical device companies, noting that the last update came in 2011 and was based on 2007 data.

Categories: News, Canada, Health Canada, Biologics and biotechnology, Drugs, Government affairs, Submission and registration, Veterinary products

Tags: pharmaceutical fees, medical device fees, Health Canada fees

IMDRF Consults on Use of Registries to Support Device Approval Decisions By Zachary Brennan - Published 02 October 2017

The International Medical Device Regulators Forum (IMDRF) has opened for consultation until 1 December a third document on examining the use of registries to support medical device regulatory decision making.

Categories: News, Asia, Canada, Europe, US, IMDRF, In vitro diagnostics, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: registry data and medical devices, medical device data, approval decisions and registries

FDA Releases 5 Medical Device Guidance Documents By Zachary Brennan - Published 29 September 2017

The US Food and Drug Administration (FDA) on Friday released a draft guidance document on recommendations for submitting 510(k)s to market ultrasound devices, final guidance in the form of a Q&A on the CDRH appeals process, final guidance on developing and responding to deficiencies, final guidance on display devices for diagnostic radiology and draft guidance on the classification and requirements for laser illuminated projectors.

Categories: News, US, FDA, Medical Devices

Tags: medical device FDA guidance

CDRH Plots Creation of New 'Super Office,' Alternative 510(k) Pathway By Zachary Brennan - Published 27 September 2017

Jeff Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told attendees at the final session at AdvaMed’s MedTech conference in San Jose, California, that his center is plotting the creation of a new "super office."

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices

Tags: postapproval, 510(k) pathway, medical device approvals, total product life cycle super office

MDSAP Update: Canada's 2019 Deadline Still on Track By Michael Mezher - Published 11 September 2017

Speaking at RAPS' 2017 Convergence on Monday, officials from two international regulators and representatives from auditing organizations offered the latest on the Medical Device Single Audit Program (MDSAP).

Categories: News, Japan, Canada, Latin America and Caribbean, Oceania, US, Anvisa, FDA, Health Canada, MHLW, PMDA, TGA, Medical Devices

Tags: MDSAP, Medical Device Single Audit Program

CDRH Releases 8 Warning Letters for Foreign, US Device Manufacturers By Zachary Brennan - Published 06 September 2017

About a week after the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) was criticized for sending a historically low number of warning letters so far in 2017, a flood of new letters were released Wednesday.

Categories: News, Asia, Europe, US, CDRH, Manufacturing, Medical Devices

Tags: warning letters, medical device warnings

European Regulatory Roundup: Industry Seeks Post-Brexit System Prioritizing Ties to EMA (31 August 2017) By Nick Paul Taylor - Published 31 August 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Brexit, medical device directives, PSUR

Procedures for Device Advisory Committee Meetings: FDA Finalizes Guidance By Zachary Brennan - Published 31 August 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance from 2015 on advisory committee meetings.

Categories: News, US, CDRH, Compliance, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: medical device advisory committee meetings

Some FDA Medical Device, Generic Drug User Fees Spike in FY 2018 By Zachary Brennan - Published 28 August 2017

Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) and Medical Device User Fee Amendments of 2017 (MDUFA IV), the US Food and Drug Administration (FDA) will collect significantly higher user fees for some applications than in recent years though how the fees are calculated has been restructured under the two new agreements.

Categories: News, US, FDA, Business and Leadership, Compliance, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: generic drug user fees, medical device user fees, MDUFA IV, GDUFA II

Qualifying Medical Device Development Tools: FDA Finalizes 2013 Guidance By Zachary Brennan - Published 09 August 2017

The US Food and Drug Administration (FDA) on Wednesday finalized guidance first drafted in 2013 to formalize a program that qualifies medical device development tools (MDDT) for use in device development and evaluation programs.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices

Tags: MDDT, medical device development tools, FDA guidance

Proposed and Final FDA Rules: What’s Left in 2017 By Zachary Brennan - Published 08 August 2017

The US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017, according to an updated list of Department of Health and Human Services rulemakings.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: FDA rulemakings, biologics manufacturing inspections, de novo, medical device rulemakings

Asia Regulatory Roundup: Australia Proposes to Align Device Regulations With EU (1 August 2017) By Nick Paul Taylor - Published 01 August 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, TGA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, medical device regulations, online regulatory filing

FDA Updates on Digital Health Plans, Software Pre-Certification Pilot By Michael Mezher - Published 27 July 2017

The US Food and Drug Administration (FDA) on Thursday released new details on its plans for regulating digital health technologies, including more information about its upcoming pilot program to pre-certify software-based medical devices.

Categories: News, US, CDRH, Medical Devices, Submission and registration

Tags: Pre-Certification, PreCert Pilot, Software as a Medical Device, SaMD, Digital Health

Senate Health Bill Would Repeal Device Tax By Michael Mezher - Published 22 June 2017

Senate Republicans on Thursday released a draft version of their bill to repeal the Affordable Care Act that, like the American Health Care Act passed in the House last May, would repeal most of the taxes created by the 2010 law.

Categories: News, Government affairs, Medical Devices

Tags: Medical Device Tax

6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation By Paul Brooks - Published 15 June 2017

When the EU’s new Medical Devices Regulation (MDR) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key. Following are six things you should be doing to get ready.

Categories: Europe, EC, Medical Devices

Tags: Europe MDR, medical device regulation, new device regulations in Europe

FDA Pilot to Sign Off on Low-Risk Digital Health Products Without Premarket Review By Zachary Brennan - Published 15 June 2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday announced an upcoming pilot program that would create a third-party certification program under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA review.

Categories: News, US, FDA, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: digital health, FDA digital health, software as a medical device

Navigating the Medical Device User Fee Act (MDUFA) By Denise Gottfried MS, MBA, RAC, Patricia Maguire, PhD, Angeline Chooi, Adam Eldridge, PhD, Jonathan Gottfried, MBA - Published 25 May 2017

This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations.

Categories: Features, US, CDRH, Medical Devices, Submission and registration

Tags: MDUFA, Medical Device User Fee Act, 510(k), PMA, User Fees

Asia Regulatory Roundup: CFDA Seeks to Exempt More Devices From Clinical Trials (23 May 2017) By Nick Paul Taylor - Published 23 May 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices

Tags: Asia Regulatory Roundup, NPPA, medical device exemptions, PIC/S

RAPS and Industry Experts Join Forces for Dedicated MDR Workshop By RAPS Staff - Published 18 May 2017

RAPS is bringing together a panel of Europe’s top industry experts to deliver a dedicated workshop on the new EU regulations for medical devices and in vitro diagnostic devices.

Categories: HTML, Articles, Under RAPS, Europe, RAPS

Tags: EU, Medical Device Regulations, IVD Regulations