fda-consultant-specialist

To identify the correct FDA submission pathway, you evaluate device classification and intended use to select 510(k), PMA, or De Novo. This requires analyzing predicate devices and substantial equivalence to determine the appropriate premarket route.

QSR and CAPA compliance requires mapping device quality system processes to 21 CFR 820 standards. This involves structuring corrective and preventive action workflows to align with FDA regulatory requirements and accelerate compliance activities.

Connected medical devices require HIPAA considerations for PHI handling and cybersecurity alignment for FDA submission. This includes implementing a Software Bill of Materials (SBOM) and vulnerability management references to meet regulatory guidance.

A De Novo classification request is needed instead of a 510(k) submission when no legally marketed predicate device exists. This regulatory pathway applies to low-to-moderate risk novel devices that do not meet substantial equivalence criteria for 510(k).

Accelerate FDA regulatory planning by generating structured guidance and reference matrices for pathway selection. This approach delivers required documents and best-practice strategies to reduce time to decision for medical device teams.