Breakthrough Program
Introduction
IVD manufacturer
The company is a highly innovative IVD manufacturer start-up.
Their device is CE marked and the client was looking to obtain FDA approval for sale on the US market.
Apotech Consultants
One consultant worked part-time on the project. The main focus was to design the rationale to be eligible for a Breakthrough/ SteP application.
Standards & Tools
- FDA 510(k)
- 21 CFR Part 820
- Breakthrough and SteP program guidances
Scope of work
Identified the best FDA pathway
Set up a SteP application
Supported the client in their interaction with FDA
Submit FDA dossier
Key numbers
Team
0.5 FTE
Location
UK
Length
6 months
Type
Time and Material
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