COVID Testing Conundrum Feeds FDA Resource, Reform Debates

article image
ARTICLE SUMMARY:

The pandemic experience will be a major factor in upcoming user fee talks and in a diagnostics regulatory reform debate that continues to escalate.

The COVID-19 pandemic is all at once presenting a massive challenge to FDA’s workload capacity in the diagnostics space and placing a big spotlight on the instabilities in the US diagnostics oversight framework. As a result, FDA’s ever-evolving approach to the COVID-19 testing challenge will be a key driver in several upcoming Washington, DC, debates in the medtech sector, particularly around agency resources and diagnostics regulatory reform.

×

This article is restricted to subscribers only.

To continue reading, select one of the options below:

Existing Subscriber?


Sign In to continue reading.


Need Multi-User Access?

Gain access for your entire organization.

Get Quote Check to see if your company already has access

Subscribe to Market Pathways:

Actionable intelligence exploring the people, challenges, and opportunities impacting the global medtech community.

Subscribe to Market Pathways
Sign up for All-Access

Join our global community with a subscription to both MedTech Strategist and Market Pathways for one low price.

All-Access

Questions?

We're here to help! Please contact us at: