FDA's Move to Modernize 510(k) Process Welcomed by Some; Others Stress Caution

Jan 22, 2019

|

Premium

NEW YORK (360Dx) – As the US Food and Drug Administration moves to update the 510(k) clearance pathway for many in vitro diagnostics, some are applauding the step, but others are stressing caution.

Get the full story with
360Dx Premium

Only $95 for the
first 90 days*

360Dx Premium gives you:
✔ Full site access
✔ Interest-based email alerts
✔ Access to archives

Never miss another important industry story.

Try 360Dx Premium now.

You may already have institutional access!

Check if I qualify.

Already a 360Dx or GenomeWeb Premium member?
Login Now.

*Before your trial expires, we’ll put together a custom quote with your long-term premium options.

Not ready for premium?

Register for Free Content
You can still register for access to our free content.

Featured White Papers

The Ultimate Guide to Mouse Clinical Trials

A Guide to Selecting Your Next Immuno-Oncology Model

Feb

21

Featured Webinar

Case Study: 'Companion Informatics' to Automate Immunotherapy Manufacturing and Treatment

This webinar will provide a first-hand look at how Gradalis, a clinical-stage immunotherapy developer, is using an information management solution from L7 to streamline its research, clinical, and manufacturing operations.

Feb

26

Featured Webinar

A Cellular and Molecular Phenotyping Pipeline for Target Characterization in FFPE Biobank Samples

This webinar will demonstrate how a research team at the Firestone Institute for Respiratory Health at McMaster University developed a cellular and molecular phenotyping pipeline using archived samples of lung tissue derived from patients diagnosed with fibrotic interstitial lung disease.

Mar

14

Featured Webinar

A Multiomics Approach to Defining the Nature of Early Malignant Transformations of the Immune System

In this webinar, Dr. Wendy Béguelin of Weill Cornell Medicine will discuss how she used the BD Rhapsody single-cell RNA-seq platform and YFP floxed reporter mouse models to study how lymphoma-associated mutations disrupt the immune system by affecting GC B-cell states, explaining the biology of initiation of low-grade follicular lymphoma.

Mar

20

Featured Webinar

A New Multiplex Syndromic System For Respiratory Diagnosis And Improved Patient Care

This webinar will discuss how a new multiplexed testing system can help physicians rapidly diagnose acute respiratory infections in the near-patient setting.

Main menu