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Filtering on: "topics medical devices"

Showing 1 – 25  of 1804

Regulatory Recon: Teva Said to Reveal Restructuring Plan Thursday; Sanofi Looks to Pipeline to Offset Recent Setbacks (13 December 2017) By Michael Mezher - Published 13 December 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Medtronic Settles Deceptive Advertising Lawsuit for $12M By Zachary Brennan - Published 13 December 2017

State attorneys general in Massachusetts, Oregon, California, Illinois and Washington on Wednesday announced a $12 million multistate settlement with Medtronic to resolve claims the company deceptively marketed one of its devices known as Infuse.

Categories: News, US, Advertising and Promotion, Medical Devices

Tags: Medtronic, Infuse, deceptive marketing

Regulatory Recon: FDA Approves First Drug for Eosinophilic Granulomatosis with Polyangiitis; Allergan Acquires Ailing Repros (12 December 2017) By Michael Mezher - Published 12 December 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

CDRH Sees Spike in Pre-Market Submissions With Patient-Reported Outcome Measures By Zachary Brennan - Published 12 December 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday issued its first report on patient-reported outcomes (PROs), noting a significant uptick in PRO data submitted in 2017.

Categories: News, CDRH, Clinical, In vitro diagnostics, Medical Devices, Postmarket surveillance

Tags: patient-reported outcomes, medical device submissions

Congress Looks to Delay Medical Device Tax by 5 Years By Zachary Brennan - Published 12 December 2017

The House GOP are looking to bring together an 11th-hour fix to stop a tax on medical device companies from taking force as of 1 January 2018.

Categories: News, US, Government affairs, Medical Devices

Tags: device tax, AdvaMed

Overview of Annex I, In Vitro Diagnostic Directive and the new In Vitro Diagnostic Regulation By Yvonne Middlefell, FRAPS, RAC - Published 12 December 2017

This article provides an overview of Annex I, Essential Requirements 98/79/EC and helps clarify understanding of the new content of Annex I, General Safety and Performance Requirements. It is aimed at regulatory professionals who will benefit from having knowledge of In Vitro Diagnostic Medical Devices General Requirements and Essential Requirements (ERs) as well as requirements for risk management, software, labeling, self-testing devices and instructions for use.

Categories: Features, Europe, EC, In vitro diagnostics, Labeling, Medical Devices, Submission and registration

Tags: IVDR, Annex 1, Risk Management

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

Successful Human Factors Programs: Key Considerations from a Regulator's Perspective By Melissa R. Lemke - Published 12 December 2017

This article provides two regulatory leaders insight on human factors engineering considerations for helping manufacturers optimize user interfaces and successfully meet regulatory expectations to bring safe, effective and usable medical devices to market. It was developed from an interview with Shannon Hoste, team lead of the Center for Devices and Radiological Health's (CDRH's) human factors premarket evaluation team and Michael Ryan, acting deputy director in the division of anesthesiology, general hospital, respiratory, infection control, and dental devices.

Categories: Features, US, FDA, Medical Devices, Research and development

Tags: Human Factors Engineering, HFE, Guidance

What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More By Zachary Brennan - Published 11 December 2017

While recognizing that comparison testing for 510(k) applicants can be outdated, especially for newer medical devices, the US Food and Drug Administration (FDA) announced Monday that in the first quarter of 2018, new draft guidance will be released to address an alternative pathway for demonstrating substantial equivalence.

Categories: News, US, CDRH, Government affairs, In vitro diagnostics, Medical Devices, Research and development

Tags: CDRH guidance, 510(k) alternative pathway, PMA

Regulatory Recon: News From ASH 2017; Drugmakers Sue to Block Calif. Price Law (11 December 2017) Published 11 December 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Experts Look For Lessons in FDA's Pacemaker Cybersecurity Recall By Michael Mezher - Published 08 December 2017

In a paper in JAMA this week, two experts highlight lessons that could be learned from the US Food and Drug Administration's (FDA) first major cybersecurity-related recall for a permanent implantable medical device.

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

Tags: Cybersecurity

Regulatory Recon: Trump Signs Short-Term Funding Bill Averting Shutdown; Philippines Seeks $59M Refund for Sanofi Dengue Vaccine (8 December 2017) By Michael Mezher - Published 08 December 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Sage Rises as Depression Drug Succeeds in Phase II; Edwards to Buy Harpoon for $250M (7 December 2017) By Michael Mezher - Published 07 December 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Backs Off From Regulating Certain Types of Health Software By Zachary Brennan - Published 07 December 2017

The US Food and Drug Administration (FDA) on Thursday unveiled three guidance documents – two draft and one final – that clarify which types of software will be regulated.

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Medical Devices, Research and development

Tags: digital health, health software, 21st Century Cures

Regulatory Recon: FDA Approves Novo Nordisk's Diabetes Drug Ozempic; Australian Competition Watchdog Sues GSK, Novartis Over Pain Relief Marketing (6 December 2017) By Michael Mezher - Published 06 December 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Warns California Device Company for Failing to Disclose Serious Injury By Zachary Brennan - Published 05 December 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last month to Sacramento, California-based Hand Biomechanics Lab after the firm failed to submit a report to the agency of a serious injury that may have been caused by one of the company’s medical devices.

Categories: News, US, CDRH, Compliance, Medical Devices

Tags: warning letter, device injury

Regulatory Recon: Galectin Plummets After NASH Candidate Fails in Phase IIb Trial; Montana Sues Purdue Over Opioid Epidemic (5 December 2017) By Michael Mezher - Published 05 December 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

NEST Seeks Medical Device Test Cases for Using Real World Evidence By Zachary Brennan - Published 05 December 2017

The National Evaluation System for health Technology Coordinating Center (NESTcc) this week put out three requests for proposals to help it build the case for using real world evidence for regulatory and coverage decisions for medical devices.

Categories: News, US, FDA, Clinical, In vitro diagnostics, Medical Devices, Postmarket surveillance, Preclinical, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: NEST, NESTcc, real world data, real world evidence

Asia Regulatory Roundup: Australia Bans Transvaginal Mesh Products (5 December 2017) By Nick Paul Taylor - Published 05 December 2017

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

Categories: News, China, Oceania, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: transvaginal mesh, confidential information, medicine naming

Regulatory Recon: CVS to Buy Aetna for $69B; FDA Approves Heart Protection Claims for Amgen's Repatha (4 December 2017) By Michael Mezher - Published 04 December 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Finalizes Guidance to Help CMS With Coverage Decisions on Devices By Zachary Brennan - Published 04 December 2017

The US Food and Drug Administration (FDA) on Monday finalized guidance meant to assist the Centers for Medicare and Medicaid Services (CMS) in determining whether or not an investigational device should be reimbursed by CMS.

Categories: News, US, FDA, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: CMS coverage of medical devices, FDA guidance

3D Printing: FDA Finalizes Guidance for Medical Devices By Michael Mezher - Published 04 December 2017

The US Food and Drug Administration (FDA) on Monday finalized guidance on medical device additive manufacturing, also known as 3D printing.

Categories: News, US, FDA, Manufacturing, Medical Devices

Tags: 3D Printing, Additive Manufacturing, Final Guidance

Regulatory Recon: Astellas Acquires MitoBridge in $450M Deal; National Academy of Sciences Report Lays Out Steps to Cut Drug Prices (1 December 2017) By Michael Mezher - Published 01 December 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

CE Marking of In Vitro Diagnostic Medical Devices Under the New EU Regulation By Jonathan Bray, PhD, Michelle O'Connor, PhD, Robert D. Cumming - Published 01 December 2017

This article explains the revised classification rules, conformity assessment procedures and new requirements for clinical evidence to support the safety and performance of an In Vitro Diagnostic (IVD) medical device. Of significance, the In Vitro Diagnostic Device Regulations (EU 2017/746) transition from the prior two class system under the IVD Directive (98/19/EC) to a four-class, risk-based classification system.1 The regulations, intended to affect greater IVD safety and reliability, expand the definition of an IVD to include software used as any part of an IVD, as well as an IVD used for providing information concerning the predisposition to a medical condition or disease. An IVD also may be a device used to predict a treatment response or reaction to a treatment. Moving forward, all Class B through Class D IVDs will require some level of conformity assessment by an independent Notified Body.

Categories: Features, Europe, EC, Clinical, In vitro diagnostics, Medical Devices, Submission and registration

Tags: MDR, IVDR, CE Marking

Implementing the New EU Medical Devices Regulations By Randolph Fillmore - Published 01 December 2017

This article discusses the steps toward implementing the new EU regulations on medical devices with a focus on better pre-market control, establishing oversight and data systems. It is based on a presentation given by Salvatore Scalzo at the RAPS EU Regulatory Essentials Workshop held in Brussels, Belgium in July 2017.

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

Tags: MDR, IVDR