FDA Introduces Triage Pilot Program: Increasing efficiencies for device review

ALBERTO GUTIERREZ for Quality Digest

During the next few months, manufacturers of certain in vitro diagnostic and radiology products may start to notice they are getting decisions on their premarket notification submissions, aka 510(k), sooner than expected. This will be due to a six-month pilot program called Triage, launched recently by the Food and Drug Administration’s (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety, a part of the Center for Devices and Radiological Health (CDRH).

The goal of Triage is to improve efficiencies in the device review process. Reviewers will focus more of their time and attention on novel and higher-risk devices, like companion diagnostics devices, and less time on devices that are lower risk and have well-known and well-understood safety and effectiveness profiles.

As the name “Triage” suggests, when certain 510(k) submissions are submitted, reviewers will make an assessment of the level of resources needed to complete a review, based on a quick assessment of the submission’s content and completeness. High-quality submissions that meet certain criteria and contain all of the information needed for a substantial equivalence evaluation will be slated for a 30-day Quick Review. Those 510(k) submissions not meeting these criteria would receive the standard review (generally 90 days) consistent with user fee performance goals.

http://www.qualitydigest.com/inside/fda-compliance-article/fda-introduces-triage-pilot-program.html

FDAnews Management Report Available

http://www.onlinetmd.com/fda-management-report-040312.aspx

Despite years of harmonization talks, the EU and United States still follow very different marketing approval processes for medical devices. In addition, when the EU's MDD went into effect in 2010, those differences are more pronounced.
Failing to know the differences could critically handicap your time to market and ability to operate efficiently.
Failing to comply with those differences could shut you out of EU markets completely.
EU and FDA regulators continue to apply different sets of requirements for medical device market approval, despite longstanding attempts at harmonization.
Do you understand how CE marking, PMA approval, and 510(k) clearance processes differ? Are you prepared for the impact of recent major revisions to the EU Medical Devices Directives?
Here is how to make sure you're fully informed – and in compliance.