Typical FDA Support:
FDA Q-Submissions: Need feedback from FDA on a protocol or testing requirements? A Q-submission is the perfect way to get timely feedback from FDA prior to spending significant resources executing testing.
FDA 513(g): Struggling to determine the proper device product code? A 513(g) is a great way to supply FDA with a device description and intended use allowing FDA to give guidance on the appropriate device codes.
FDA 510(k): Want to sell your medical device? A 510(k) submission may be the route to entering the US market.
Additional Regulatory Support:
Regulatory Strategy: What is the least burdensome approach to getting your medical device to market?
Marketing Material: Review of claims and marketing to help ensure compliance
Product Change after Clearance: Have you made changes to the device after receiving FDA clearance? It is important to document an assessment of changes to determine whether an new submission to FDA is required.