Paving your way to FDA clearance

FDA - Regulatory Strategic Planning

Intended use and indications for use strategy- stepwise approach to facilitate time to market
Product classification & product code/s
Predicate devices
Applicable performance, safety, EMC and labeling standards & guidelines
Clinical/ Preclinical requirements to support the claims
Regulatory assessment of product changes (LTF/ 510k)

FDA- Preparation & Submission of Regulatory Binder

FDA Pre-Sub, Pre-market Notification- 513(g), 510(k), De Novo, Pre IDE, IDE submission
Interactive work and face to face meetings with FDA
Establishment Registration & Device Listing
Product Labeling