2 ms·
I see it's being prescribed, and to a small-ish number of people (400), so perhaps it's in a trial phase? FDA has 5 phases for medical device development (googl
by ok_dad 4y ago
I see it's being prescribed, and to a small-ish number of people (400), so perhaps it's in a trial phase? FDA has 5 phases for medical device development (googled below):
Step 1: Device Discovery and Concept.
Step 2: Preclinical Research-Prototype.
Step 3: Pathway to Approval.
Step 4: FDA Device Review.
Step 5: FDA Post-Market Device Safety Monitoring.
They could be on step 3, where they do clinical trials. Maybe working with the VA, or perhaps they advertised at VA hospitals or veteran's groups. I would imagine that's the easiest group to find and recruit into your trial.