IVDD Regulatory Consulting

U.S. IVDD Regulatory Submission Support

Our team specializes in submission types that include:

• Premarket Approval (PMA): With a collaborative approach between our team and your internal teams, we guide you from pre-submission (Q-sub) meetings, if needed, through the integration of quality management systems (QMS) and alignment with Good Manufacturing Practice (GMP) standards. Our expert PMA services support data integrity with our Computer System Compliance (CSC), Computer System Validation (CSV) and Computer System Audit (CSA) services.
• 510(k) submissions: FDAQRC helps you find the right predicate for your 510(k) submission with extensive searches of FDA databases. We also develop strong Substantial Equivalence (SE) submissions, using our experience to predict and address reviewer concerns before they affect your launch. Our team audits your testing data against current expectations and prepares your final dossier with correct pagination, validation and formatting so it is more likely to pass the FDA’s Refuse to Accept (RTA) screening. Through the process, we manage communications with the FDA and address any Additional Information (AI) requests.

De Novo Classification for medical devices: Our team can help you determine whether your device qualifies for De Novo classification, prepare you for FDA pre-submission and assist you with defining special controls. We work to reduce the risk of delayed launches by offering comprehensive assessments of trial master files and investigator sites to ensure compliance with Good Clinical Practice (GCP). We reduce your internal workload by managing your De Novo submission end-to-end, including targeted gap analyses, remediation plans and mock audits to ensure inspection readiness.

IVDD Post-Approval Compliance 

Compliance is not a one-time event. We provide ongoing regulatory guidance to keep your IVDDs compliant throughout their life cycle. Post-approval, we support your team in ensuring your diagnostic devices perform as required in real-world conditions and help you maintain manufacturing and testing best practices to maintain production consistency. 

Remediation Services 

If you have received FDA Warning Letters or Form 483 observations, our team can deliver inspection-ready solutions. We draft responses, conduct root cause analyses, perform gap assessments and deliver documentation supporting compliance. If an assessment shows a compliance gap, we can develop preventive and corrective action plans to help you get compliant.