510(k) Submissions
Many devices require a 510(k) submission before entering the US market. Our experienced team can guide you through every step, reducing time to approval and minimising regulatory risk.
- Predicate Device Strategy: Identify the right FDA product code, regulation number, and predicate device to streamline testing and improve success.
- Testing & Data Requirements: Research applicable FDA pathways (Traditional, Special, Abbreviated, Safety & Performance) and define clinical and regulatory requirements.
- Gap Analysis: Evaluate your existing documentation against FDA expectations and create a clear gap report.
- Compilation & Submission: Complete your 510(k), submit it to the FDA, and handle follow-up queries through to clearance.
We help avoid pitfalls like Refuse to Accept (RTA) notifications or Additional Information (AI) requests.
Trusted by top-tier teams worldwide
Featured case studies
Borderline device classification
Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and wellness product manufacturer identified revenue opportunities marketing their cosmetics devices with increase claims. Apotech was engaged to perform a blanket regulatory assessment of cosmetic devices and provide judgement and pathways for market authorisation as a medical device…
- « Previous
- 1
- 2