Search Results for CLIA

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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

CLIA Waiver Decisions: FDA Begins Posting Summaries By Michael Mezher - Published 03 October 2017

The US Food and Drug Administration (FDA) on Friday began posting decision summaries for its Clinical Laboratory Improvement Amendments (CLIA) waiver decisions for in vitro diagnostics (IVDs) as part of a pilot to boost transparency.

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

Tags: CLIA, CLIA Waiver by Application

Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program By Zachary Brennan - Published 23 August 2016

The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017.

Categories: News, US, CDRH, Government affairs, Medical Devices, Postmarket surveillance, Preclinical, Project management, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: MDUFA, medical device user fee agreement, AdvaMed, MITA, CLIA, LDTs

FDA Raises Questions Over DTC Genetic Tests Offered at Rite Aid By Zachary Brennan - Published 18 November 2015

The US Food and Drug Administration (FDA) called out another direct-to-consumer (DTC) genetic testing company on Monday over an unapproved test, this time going after one recently made available at the drugstore chain Rite Aid.

Categories: News, US, FDA, Advertising and Promotion, Distribution, Drugs, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Harmonyx, DTC genetic tests, FDA, CLIA, CAP, Rite Aid

FDA, CMS Teaming up to Co-Regulate Lab-Developed Tests Published 20 April 2015

The US Food and Drug Administration (FDA) is teaming up with the US Centers for Medicare and Medicaid Services (CMS) to better regulate lab-developed tests (LDTs), which are currently overseen—haphazardly—by both agencies.

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

Tags: LDTs, Lab Developed Tests, CMS, CLIA, FDA/CMS Task Force on LDT Quality Requirements

Types of In Vitro Diagnostics: Clearing Up the Confusion By Heidi Hancock Strunk, RAC - Published 16 January 2015

In vitro diagnostics: It is easy to get lost in a seemingly foreign language of acronyms for IVDs—ASRs, RUOs, LDTs and more. Can a company explain the differences between ASRs and LDTs—not to mention RUOs, IUOs, “home brew” tests and companion IVD diagnostics? An overview of the various types of IVDs.

Categories: Features, US, FDA, In vitro diagnostics

Tags: FDA, in vitro medical devices, IVDs, FDA guidance, GPRs, CLIA

How Should FDA Regulate Lab-Developed Tests? Agency Wants to Know By Alexander Gaffney, RAC - Published 25 November 2014

The US Food and Drug Administration (FDA) plans to hold a meeting to collect public feedback on a controversial proposal to revoke a longstanding regulatory exemption for lab-developed tests (LDTs) and regulate them more like traditional medical devices.

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

Tags: LDT, Lab Developed Test, CLIA, FDA Workshop

In Major Shift, FDA to Regulate Lab-Developed Tests as Normal Devices By Alexander Gaffney, RAC - Published 01 August 2014

The US Food and Drug Administration (FDA) announced Thursday that it plans to reverse a decades-old policy and begin regulating Lab-developed Tests (LDTs) more similarly to in vitro diagnostic devices (IVDs).

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

Tags: LDTs, Lab-Developed Tests, ACLA, Draft Guidance, LDT Regulation, CLIA

New FDA Guidance Explains the Ins and Outs of the CLIA Categorization Process for IVDs By Alexander Gaffney, RAC - Published 12 March 2014

Categories: US, FDA, CBER, CDRH

Tags: CLIA Categorization, CLIA, LDT, Latest News, IVD, guidance

Citizen Petition Claims Lab-Developed Tests aren't Devices and are Beyond FDA Regulation By Alexander Gaffney, RF News Editor - Published 06 June 2013

Categories: US, FDA

Tags: Laboratory-Developed Tests, ACLA, CLIA, Lab-Developed Tests, LDT, Laboratory, Citizen Petition, Latest News