Search Results for de novo

Showing 1 – 14

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

FDA Classifies Post-Concussion Test By Michael Mezher - Published 05 December 2016

Months after clearing the first computer-based test intended to measure cognitive function after a suspected concussion, the US Food and Drug Administration (FDA) on Monday said it considers such devices to be Class II, or moderate risk devices.

Categories: News, US, FDA, Labeling, Medical Devices, Submission and registration

Tags: ImPACT, Concussion, Post-Concusion, Class II, De Novo

OpenFDA Releases Huge Trove of Medical Device Data By Michael Mezher - Published 02 September 2015

On Monday, the US Food and Drug Administration (FDA) released a vast amount of medical device data to its openFDA platform.

Categories: News, US, FDA, Communication, Government affairs, Medical Devices, Postmarket surveillance, Research and development

Tags: openFDA, device approvals, 510(k), de novo

FDA Approving New High-Risk Devices at Fastest Pace in Last Decade, Report Finds By Alexander Gaffney, RAC - Published 23 October 2014

A new analysis by the California Healthcare Institute (CHI) indicates that after years of unprecedentedly high review times, the US Food and Drug Administration is finally beginning to accelerate the pace at which it reviews innovative high-risk medical devices.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Submission and registration

Tags: PMA, 510(k), De Novo, Review Times, Review Cohort, Medical Device Approvals

Flip a Coin: FDA Approves Kidney Diagnostic With 50% False Positive Results By Alexander Gaffney, RAC - Published 09 September 2014

If you're looking for a case study in tough calls—a product which, but for its indication, might never have been approved—an approval late last week by the US Food and Drug Administration (FDA) might be as good as you'll see this year.

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

Tags: De Novo, NephroCheck, Approval, False Positive

FDA Finalizes Extensive Guidance on Pivotal Trials for Medical Devices By Alexander Gaffney, RF News Editor - Published 07 November 2013

Categories: US, FDA

Tags: De Novo, 510(k), PMA, guidance, clinical trials, medical device

FDA Clears Gastroenteritis Diagnostic Device Through De Novo Pathway By Alexander Gaffney, RF News Editor - Published 15 January 2013

Categories: FDA

Tags: De Novo, medical device

FDA Beefs up Medical Countermeasure Program with new 510(k) Guidance By Alexander Gaffney, RF News Editor - Published 09 November 2012

Categories: FDA

Tags: Animal Pathway, Medical Countermeasure, MCM, Latest News, De Novo, 510(k), In Vitro Diagnostic

FDA Clears Ingestible Medical Device Aimed at Boosting Adherence By Alexander Gaffney - Published 31 July 2012

Categories: FDA

Tags: Ingestible, Adherence, Proteus, Latest News, De Novo, medical device

CDRH Releases New Training Module for Guidance on Benefit-Risk Determinations By Alexander Gaffney - Published 10 April 2012

Categories: FDA, CDRH, Education

Tags: Risk/Benefit, Benefit:Risk, Benefit-risk, Learn, Module, application, Latest News, De Novo, PMA, guidance, training

FDA Releases New Guidance For Industry for Benefit-Risk Evaluations in PMAs, De Novo Classifications By Alexander Gaffney - Published 27 March 2012

Categories: FDA, CDRH

Tags: Determination, Evaluation, Benefit, Latest News, De Novo, PMA, risk, medical device

Consumers Groups Attack FDA Over De Novo Process By Alexander Gaffney - Published 01 March 2012

Categories: FDA, CDRH

Tags: Public Citizen, endovascular suturing, Consumers Union, Latest News, Hamburg, De Novo, risk, medical device

McCain, Casey Introduce Bill to Remove Medical Device Regulations By Alexander Gaffney - Published 07 February 2012

Categories: FDA

Tags: S.2067, SET Devices Act, Casey, McCain, Legislation, Latest News, De Novo, Senate, Bill, Congress

Senator Brown Proposes Modifications to the De Novo Process Published 06 December 2011

On December 5, 2011, Senator Scott Brown (R-MA) introduced S. 1943, the "Novel Device Regulatory Relief Act of 2011."  

Categories: FDA, Regulatory intelligence

Tags: De Novo, Senate, Congress, Political, reform, Process, medical device