Search Results for In VItro Diagnostics

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New Draft Guidance Looks to Update FDA's Replacement Reagent Policy for IVDs By Michael Mezher - Published 22 December 2017

In a new draft guidance released earlier this week, the US Food and Drug Administration (FDA) looks to update a 2003 policy that allows in vitro diagnostic makers to avoid having to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

EU Council Unanimously Adopts MDR, IVDR: Next Stop EU Parliament By Michael Mezher - Published 07 March 2017

The EU's new rules governing medical device and in vitro diagnostics (IVDs) are one step away from being fully adopted.

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

Tags: Medical Device Regulations, MDR, In Vitro Diagnostics Regulations, IVDR, EU Council

FDA Delays Finalization of Lab-Developed Test Draft Guidance By Zachary Brennan - Published 18 November 2016

The US Food and Drug Administration (FDA) on Friday said it will wait for the new administration and halt the finalization of guidance that would have changed the way lab-developed tests (LDTs) are regulated.

Categories: News, US, CDRH, Government affairs, In vitro diagnostics

Tags: LDTs, lab-developed tests, in vitro diagnostics

WHO on Prequalified IVDs: Changes Must be Reported By Zachary Brennan - Published 15 February 2016

Manufacturers of prequalified in vitro diagnostics (IVD) must submit change reports to the World Health Organization or risk having their product de-listed from the compendium of prequalified IVDs.

Categories: News, Asia, Europe, US, WHO, Compliance, Due Diligence, Government affairs, In vitro diagnostics, Manufacturing

Tags: prequalified in vitro diagnostics, World Health Organization guidance, draft guidance

House Committee Floats Draft Bill for New FDA Regulations of In Vitro Clinical Tests By Zachary Brennan - Published 23 October 2015

In advance of a hearing next Thursday, the House Energy & Commerce Committee has released a draft discussion bill that would set up new regulations for in vitro clinical tests.

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Regulatory intelligence, Regulatory strategy

Tags: LDTs, lab-developed tests, IVDs, in vitro diagnostics, in vitro clinical tests, diagnostics