Medical Device Regulatory & Commercialisation
End-to-end FDA regulatory strategy and commercialisation advisory for Class I, II, and III medical device manufacturers. From predicate analysis to commercial launch and post-market compliance.
FDA Regulatory Pathways We Navigate
Demonstrates that a device is substantially equivalent to a legally marketed predicate device. The most common pathway for moderate-risk devices.
The most stringent FDA pathway, requiring valid scientific evidence demonstrating reasonable assurance of safety and effectiveness for high-risk devices.
For novel low-to-moderate risk devices without a valid predicate. Creates a new classification and can serve as a predicate for future 510(k) submissions.
Permits investigational use of a device in a clinical study to collect safety and effectiveness data in support of a PMA or other premarket submission.
End-to-End Medical Device Advisory
Device classification analysis, predicate identification, and pathway recommendation for US (FDA), EU (MDR), and international markets.
Rigorous predicate device analysis and substantial equivalence argumentation for 510(k) submissions, including predicate chaining strategies.
Clinical evidence gap analysis, IDE study design, existing data review, and clinical literature synthesis to support submission packages.
End-to-end preparation of 510(k), PMA, De Novo, and EU MDR Technical File documentation including testing, software, and biocompatibility sections.
Development of Q-Sub meeting requests, meeting strategy, and response to FDA feedback to de-risk regulatory pathways in advance of formal submission.
Design and implementation of post-market clinical follow-up (PMCF) plans and vigilance systems in compliance with EU MDR and FDA MDSR requirements.
US market entry strategy including distributor qualification, reimbursement landscape analysis, and commercial launch planning.
EU MDR readiness assessment and notified body selection advisory, including technical file review coordination and EUDAMED registration.
Regulatory due diligence support for private equity transactions involving medical device targets, including risk assessment and pathway gap analysis.
Representative Device Engagements
FDA 510(k) Clearance for Class II Intimate Care Therapeutic
A US-based specialty therapeutics company sought FDA clearance for a Class II intimate care device intended for therapeutic application. The product occupied a classification grey area at the intersection of medical device and wellness categories, requiring precise regulatory determination and a defensible predicate strategy. Without a direct precedent in the 510(k) database, the client faced the risk of upclassification to a higher-risk device category or an FDA additional information request that would materially extend the timeline and commercialisation cost.
Innekto Incorporated conducted a comprehensive regulatory pathway assessment, evaluating device classification under 21 CFR Part 884 and adjacent classifications. A multi-predicate 510(k) strategy was developed, anchoring the submission on substantially equivalent cleared devices through a structured predicate chain. We led preparation of the complete submission package including device description, substantial equivalence argument, biocompatibility assessment per ISO 10993, performance testing protocols, and labelling review. A Q-Sub pre-submission meeting strategy was employed to obtain FDA feedback on the predicate approach and eliminate material submission risk prior to the formal filing.
FDA 510(k) clearance obtained with no additional information requests issued. The pre-submission engagement validated the predicate strategy and produced a favourable FDA response, enabling the client to file with high confidence. Clearance was achieved within target timelines, and the client reached US market launch readiness immediately upon notification.
PMA Strategy for Novel Class III Cardiac Device
A US-based early-stage medical device company developing a novel Class III implantable cardiac monitoring system required a regulatory strategy capable of navigating the PMA pathway in parallel with securing Series B investment. The device lacked a direct predicate, precluding a 510(k) submission, and the founding team had limited prior experience managing FDA's Investigational Device Exemption (IDE) process. The company faced pressure from investors to demonstrate a defined, defensible regulatory timeline before closing the round, while simultaneously managing resource constraints that prevented overstaffing the regulatory function.
Innekto Incorporated conducted a full regulatory pathway assessment confirming the PMA route and scoping the clinical evidence requirements. An IDE study design was developed in collaboration with the client's clinical team, with primary endpoint selection, patient population definition, and statistical power calculations informed by FDA guidance for the device category. A structured Q-Sub pre-submission engagement strategy was designed to obtain FDA input on the IDE protocol before submission, reducing the risk of a clinical hold. A parallel EU MDR technical file strategy was initiated, mapping the clinical evaluation requirements and identifying a designated notified body. Investor-facing regulatory milestone documentation was prepared to support the capital raise narrative.
The pre-IDE application was accepted by FDA with no clinical hold issued and a single minor administrative query. The clinical protocol was finalised and IRB-approved within six months of engagement commencement. EU MDR technical file structure was accepted by a designated notified body, with the clinical evaluation timeline aligned with the IDE study data generation. The defined regulatory roadmap was directly incorporated into the Series B investor materials and supported successful closure of the financing round.
Discuss a Device Regulatory Engagement
Contact our regulatory team to discuss FDA strategy and market access for your device.
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