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Filtering on: "topics in vitro diagnostics"

Showing 1 – 25  of 243

FDA Warns BD Over Changes Made to Blood Collection Tubes in Lead Testing Investigation By Michael Mezher - Published 12 January 2018

After launching an investigation into the root cause of false lead test results from four of Magellan Diagnostics' LeadCare testing systems last May, the US Food and Drug Administration (FDA) on Thursday warned Becton Dickinson (BD) for failing to submit a new 510(k) for changes to its blood collection tubes.

Categories: News, FDA, In vitro diagnostics, Medical Devices

Tags: BD, LeadCare, Magellan Diagnostics, Vacutainer, Warning Letter

Device Recalls in 2017: Making Sense of the Numbers By Michael Mezher - Published 10 January 2018

Each year, the US Food and Drug Administration (FDA) designates anywhere from dozen to hundreds of medical device recalls as Class I, indicating that the risk addressed by the recall could potentially cause serious injury or death.

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

Tags: Recalls, Corrections, Removals, Class I Recall

Barriers to FDA and CMS Parallel Reviews: Fear and Bandwidth, Shuren Says By Zachary Brennan - Published 09 January 2018

Medical device companies should want to streamline the process of getting their products reviewed simultaneously by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Centers for Medicare and Medicaid Services (CMS) - so why aren’t they?

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: parallel review, Shuren, MOU

European Commission Updates Borderline Device Classification Manual By Michael Mezher - Published 08 January 2018

The European Commission (EC) last week released an update to its manual on classifying "borderline" medical devices featuring clarifications as to the medical device status and classification of on twelve additional types of products.

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

Tags: Borderline Products, MDR, IVDR

Regulatory Strategies for OTC Switch Programs, Implementing EU MDR & IVDR and a Preview of January By Gloria Hall - Published 22 December 2017

Feature articles over the past several weeks provided background, approaches, regulatory considerations, and strategies for implementing prescription to Over-the-Counter (Rx-to-OTC) switch programs; CE marking requirements of IVD medical devices under the new EU regulation; explanation of Annex I general requirements and essential requirements; implementation strategies for the new EU medical devices regulations; and medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes in India.

Categories: Features, India, Europe, US, Clinical, Over the counter drugs, Prescription drugs, In vitro diagnostics, Medical Devices

Tags: Feature Editorial

New Draft Guidance Looks to Update FDA's Replacement Reagent Policy for IVDs By Michael Mezher - Published 22 December 2017

In a new draft guidance released earlier this week, the US Food and Drug Administration (FDA) looks to update a 2003 policy that allows in vitro diagnostic makers to avoid having to submit a new 510(k) for certain changes to their tests.

Categories: News, US, FDA, In vitro diagnostics, Submission and registration

Tags: Replacement Reagent, Instrument Family, In VItro Diagnostics

2.3% Tax on Medical Device Companies to Take Effect in 2018 By Zachary Brennan - Published 21 December 2017

As some companies cheer new tax cuts, medical device companies will ring in the new year with the reinstatement of a 2.3% tax put in place by the Affordable Care Act, after efforts to permanently repeal or delay the tax failed.

Categories: News, US, Government affairs, In vitro diagnostics, Medical Devices

Tags: device tax, Obamacare, medical device company tax

FDA Offers Two New Draft Guidances on Developing Targeted Therapies By Zachary Brennan - Published 15 December 2017

The US Food and Drug Administration (FDA) on Friday published two new draft guidance documents that seek to support the development of treatments that address the underlying genetic mutations that often cause or contribute to diseases and another discussing how to determine if an in vitro diagnostic (IVD) device used in a study must undergo its own FDA review, distinct from the drug study.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs, In vitro diagnostics, Regulatory intelligence, Regulatory strategy

Tags: tumor agnostic approvals, investigational IVDs, genetic mutation

Antimicrobial Susceptibility: FDA Launches Test Website, Issues Guidance By Michael Mezher - Published 13 December 2017

The US Food and Drug Administration (FDA) on Wednesday launched a new website aimed at improving access to information that can help healthcare professionals determine which drugs are most likely to work to treat bacterial or fungal infections.

Categories: News, US, FDA, Drugs, In vitro diagnostics, Labeling

Tags: Antimicrobial Susceptibility Interpretive Test Criteria, Breakpoint, 21st Century Cures

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

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

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

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

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

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

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

FDA, CMS: Second Parallel Review Decision Ever for NGS Test By Michael Mezher - Published 01 December 2017

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and coverage decisions for Foundation Medicine's FoundationOne CDx next generation sequencing (NGS) based test.

Categories: News, US, FDA, In vitro diagnostics, Reimbursement, Submission and registration

Tags: Parallel Review, CMS, FoundationOne CDx, Breakthrough Device

FDA Issues Two Guidances on CLIA Waiver Applications, 510(k) Dual Submissions By Michael Mezher - Published 28 November 2017

The US Food and Drug Administration (FDA) on Tuesday issued two draft guidances aimed at updating its recommendations for in vitro diagnostics (IVDs) seeking a waiver from requirements under the Clinical Laboratories Improvement Amendments (CLIA) in line with provisions of the 21st Century Cures Act and the recently reauthorized Medical Device User Fee Amendments (MDUFA IV).

Categories: News, US, FDA, In vitro diagnostics, Submission and registration

Tags: CLIA Waiver, CLIA Waiver by Application, IVDs, Dual Submissions

FDA Announces Third-Party Review Pathway for Tumor Profiling Tests By Michael Mezher - Published 15 November 2017

The US Food and Drug Administration (FDA) on Wednesday announced it has cleared a next-generation sequencing (NGS) test developed by Memorial Sloan Kettering Cancer Center (MSK) that can detect 468 unique gene mutations and other molecular biomarkers in a patient's tumor.

Categories: News, US, FDA, In vitro diagnostics, Submission and registration

Tags: Next-Generation Sequencing, NGS, Tumor Profiling Tests, MSK-IMPACT, New York State Department of Health, NYSDOH

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

MDR, IVDR: Competent Authorities Lay Out Road Map By Zachary Brennan - Published 13 November 2017

The Competent Authorities for Medical Devices (CAMD) Executive Group’s EU medical device regulation and in vitro diagnostic regulation (MDR/IVDR) implementation task force has released a road map outlining key challenges and steps for various technical work streams.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: MDR, IVDR, CAMD

Eight Key Steps Toward EU-MDR Implementation By Gert Bos - Published 13 November 2017

This article offers eight steps toward ensuring compliance with the new European Union Medical Device Regulations. It is based on the author's presentation given in July 2017 on "EU Regulatory Essentials, Medical Device, and In Vitro Diagnostics: Transitioning From Current Directives to new Regulations" at the RAPS Brussels Conference.1, 2

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

House Adds Provision to Allow DoD to Approve Medical Products Outside of FDA By Zachary Brennan - Published 10 November 2017

The House of Representatives' Rules Committee on Monday will take up a provision that would expand the US Department of Defense's (DoD) ability to approve, on an emergency basis, medical products, as US Food and Drug Administration (FDA) Commissioner Scott Gottlieb pushed for the provision to be rejected.

Categories: News, US, FDA, Drugs, In vitro diagnostics, Medical Devices

Tags: Department of Defense, emergency use authorization

Notified Bodies Disclose Re-Designation Intentions Ahead of EU MDR, IVDR Deadline By Zachary Brennan - Published 08 November 2017

European notified bodies are prepping for a 26 November deadline and announcing their intentions to apply for designation as implementation of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continues.

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

Tags: notified bodies, Team-NB, MDR, IVDR

FDA Announces Streamlined Review Pathway for DTC Genetic Tests By Michael Mezher - Published 06 November 2017

The US Food and Drug Administration (FDA) on Monday detailed its plans to make it easier for companies developing direct-to-consumer (DTC) genetic health risk (GHR) tests to get those tests on the market.

Categories: News, US, FDA, In vitro diagnostics, Submission and registration

Tags: Genetic Health Risks, GHR, Direct-to-Consumer, DTC, Class II, Exempt, 23andMe, Genetic Testing