A framework for pre-submission risk screening in medical device regulatory submissions: categorising common FDA deficiency themes
£69.00
Learn how a structured framework of 24 common FDA deficiency themes can support more effective pre-submission review for 510(k), PMA, and De Novo applications
** Available for pre-order – delivery date 10 August 2026 **
English
Abstract:
Complete Response Letters and Additional Information requests from the US Food and Drug Administration (FDA) represent significant delays in medical device market authorisation, with downstream effects on patient access and commercial viability. This article by Santhosh Seshadhri and Kristian Debus develops a framework for categorising common FDA deficiency themes across 510(k), Pre-market Approval (PMA), and De Novo submissions for medical devices, and explores their potential application to pre-submission risk assessment. Through structured review of FDA guidance documents, consensus standards, public submission summaries, Warning Letters, inspection observations, and publicly disclosed regulatory interactions, 24 distinct deficiency themes were identified that represent common categories of regulatory concern across device submission pathways. Anticipated theme relevance varies meaningfully by submission pathway and device type, with software documentation, predicate equivalence, clinical evidence sufficiency, and biocompatibility data emerging as themes of particular weight. Cross-jurisdictional comparisons reveal substantial convergence, suggesting that pattern-based pre-submission screening can support manufacturers operating in multiple markets. The framework presented here is positioned as a structured method for identifying preventable sources of review friction before submission, not as a tool for predicting FDA decisions.
Learning objectives:
- Identify the 24 deficiency themes
- Distinguish how anticipated relevance varies by pathway and device category
- Apply the framework to pre-submission risk assessment
- Recognise how the framework integrates with design controls and the Quality Management System
- Evaluate the appropriate use and limitations of pattern-based screening.
About the authors:
Santhosh Seshadhri is the Founding Scientist at Sigmatwin, a regulatory risk platform focused on medical device and pharmaceutical submissions. His work encompasses systematic analysis of regulatory deficiency patterns across the US FDA, European Medicines Agency, and other major health authorities. He holds a background in regulatory science and computational pattern analysis.
Kristian Debus, PhD, is Chief Executive Officer of InfiniVida and a computational modelling and regulatory strategy leader with extensive experience in CFD (computational fluid dynamics), FEA (finite element analysis), FSI (fluid-structure interaction), digital twin methods, and FDA-facing medical device simulation workflows. His work focuses on translating advanced modelling, verification and validation, and in silico evidence into practical regulatory and product development strategies.
Specification:
17 pages plus covers, in English, supplied by email as a PDF.
This article will be published in the August 2026 issue of the Journal of Medical Device Regulation.
