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.
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Featured case studies
510(k) Submission
510(k) Submission Introduction Radiographic Dental Imagery Device – Class IIb Our client are a leading manufacturer of radiographic dental imaging systems, based in Europe. Following European success, our client set their sights on the US market. Standards & Tools FDA 21 CFR Part 820 GDPR Word Excel, Powerpoint Scope of work Review of documentation for…
Regulatory Strategy IVDR / FDA
Regulatory Strategy IVDR / FDA Introduction Deciphex Deciphex is a digital pathology workflow and integrated AI platform for research pathology, CROs and pharmaceutical companies for handling high volume drug safety pathology studies. They provide a complete GLP-compliant workflow with integrated AI screening capabilities. Standards & Tools Scope of work Brian – Director QA RA As…
Breakthrough Program
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…