We provide strategic regulatory affairs consulting for corporations navigating the FDA 510(k) Premarket Notification process.
Inquire NowA 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to premarket approval.
We analyze your device classification, product code, and predicate devices to determine the viable regulatory pathway. Early identification of the correct predicate is critical to minimizing submission delays.
Aclivi compiles the comprehensive submission dossier, including indications for use, device descriptions, labeling, and summary reports of performance testing, ensuring strict adherence to FDA formatting standards.
Our core competency lies in drafting the Substantial Equivalence (SE) argument. We bridge the gap between technical engineering data and regulatory requirements to prove safety and efficacy.
We manage all interactions with FDA reviewers, including Additional Information (AI) requests. Our team drafts scientific and legal responses to expedite the clearance timeline.
Aclivi Consulting is a regulatory affairs firm dedicated to the MedTech and Biotech sectors. We operate specifically within the domain of Class II medical devices requiring premarket notification.
We do not offer general business consulting; our focus is exclusively on the regulatory science required to achieve market access in the United States. We partner with large-scale manufacturers to ensure compliance and clearance speed.
connect@aclivi.com
100 Regulatory Way, Suite 400
Boston, MA 02110
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