FDA Attempted to Ease Reporting Timeframes for Medical Device Reporting Requirements–Did it Succeed?

ARTICLE SUMMARY:

The US agency launched a voluntary summary reporting program last year to streamline reports for qualifying product malfunctions. It’s a positive step forward for FDA, but companies should weigh the pros and cons before deciding to participate. By Mir Ali, Paula Burge, and Alexander Garnick, Navigant.

When the US Food and Drug Administration finalized its Voluntary Malfunction Summary Reporting Program last year, it intended to promote efficiency in the medical device malfunction reporting process, while ensuring enough information is gathered to effectively monitor devices.

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
Subscribe to ELITE Strategist

Become an ELITE Strategist and unlock access to both MedTech Strategist and MTS Market Pathways.

Subscribe to Elite

Questions?

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