RECENT FACET SUCCESSES – JUST A FEW HIGHLIGHTS

INDUSTRY FIRST FOR MEDICAL DEVICES:  

Facet is the first organization to work with the FDA and a medical device Sponsor to prepare and submit a combination product 510(k) using the electronic Submission Template And Resource (eSTAR) template!  Per FDA’s guidance, Electronic Submission Template for Medical Device 510(k) Submissions (Sept 2022), the eSTAR is an interactive PDF guided submission preparation tool that is intended to help Sponsors prepare and submit comprehensive and complete medical device submissions entirely in electronic format.  Submission of 510(k) applications to FDA using the eSTAR format has been voluntary since 2021, but will be required for tradition, special, and abbreviated 510(k)s and De Novo applications starting on October 1, 2023.  After obtaining agreement from the FDA to submit an eSTAR for a device-led combination 510(k), Facet helped a small ex-US company prepare and successfully submit their application electronically for Agency review.

CLINICAL HOLD LIFTED:   

Facet helped a small pharmaceutical company to obtain agreement from FDA to lift clinical hold for an early dose escalation trial.  Based on findings from one nonclinical toxicology study showing CNS effects, FDA raised concerns regarding the proposed dose escalation in an early phase clinical trial in both written communication and in a subsequent teleconference.  After the meeting, Facet and the Sponsor worked together to set the strategy for our response.  We prepared a compelling, data-driven rationale using human PK data collected from cohorts who received lower doses and proposed conservative clinical stopping rules to justify proceeding with the next dose in the study.  FDA accepted our scientific position, and the study was permitted to proceed.  If you are a small company on clinical hold or are worried you might be at risk for clinical hold, click here to talk to a Facet regulatory expert about your program.