Device Classification & Market Pathways
How a medical device or in-vitro diagnostic reaches market: risk-based classification under FDA and EU rules, product codes and regulation numbers, the 510(k) substantial-equivalence route, De Novo, PMA, HDE and IDE, the Q-Submission programme and pre-submission meetings, EU MDR and IVDR classification rules and conformity-assessment routes, notified-body selection, and the clinical evidence each pathway actually demands. Written for regulatory affairs staff and academic translational teams deciding which route a device takes and what it will cost in evidence.
Guides
SaMD Clinical Evaluation: IMDRF N41 Framework, Valid Clinical Association, Analytical & Clinical Validation, and FDA Guidance
Regulatory guide to SaMD clinical evaluation under IMDRF N41 and FDA guidance: Valid Clinical Association, Analytical Validation, and Clinical Validation.
IEC/TR 80002-1 Explained: Applying ISO 14971 Software Risk Management to Medical Devices
Understand how IEC/TR 80002-1 guides ISO 14971 risk management for medical device software, why software failure probability P1 is set to 1, and how to run sFMEA and Fault Tree Analysis.
ANSI/AAMI SW96:2023, AAMI TIR57, and UL 2900-2-1: Medical Device Security Risk Management and ISO 14971 Integration
Technical guide to ANSI/AAMI SW96:2023 and AAMI TIR57 for medical device cybersecurity risk management: how security risk evaluation (threat, vulnerability, exploitability) bridges with ISO 14971 safety risk management and UL 2900-2-1 testing.
IEC 62304 Software Safety Classification: Class A, Class B & Class C Decision Tree (Clause 4.3)
Engineering guide to IEC 62304 software safety classification (Clause 4.3): Class A, Class B, and Class C definitions, Amendment 1 external risk controls, and FDA mapping.
IEC 62304 Checklist (2006+A1:2015): Clause 5.1 SDP, Safety Classes & Audit Deliverables
Clause-by-clause IEC 62304:2006+AMD1:2015 compliance checklist covering Clause 5.1 Software Development Plan (SDP), Amendment 1 legacy software, and Class A/B/C.
IEC 62304 vs. ISO 13485 (and ISO 14971): How Medical Device QMS, Risk Management, and Software Lifecycle Standards Interlock
Direct regulatory and engineering comparison of IEC 62304 and ISO 13485 (plus ISO 14971): how ISO 13485 Clause 7.3 Design Controls, ISO 14971 risk management, and IEC 62304 Software Safety Classes A, B, and C work together for SaMD and embedded medical device software.
SaMD vs. SiMD: Software as a Medical Device vs. Embedded Software in a Medical Device Compared
Compare Software as a Medical Device (SaMD) vs. Software in a Medical Device (SiMD): IMDRF/FDA definitions, IEC 62304, IEC 82304-1 vs. IEC 60601-1, and MDR.
ISO 13485 Software Validation Checklist: Clause 4.1.6, Clause 7.5.6, Clause 7.3, and ISO/TR 80002-2
Practical engineering guide and audit checklist for ISO 13485:2016 software validation, separating QMS tool validation (Clause 4.1.6) and build/CI/CD process validation (Clause 7.5.6) from SaMD design controls (Clause 7.3 / IEC 62304) using ISO/TR 80002-2.
Formative vs. Summative Usability Testing for Medical Devices: FDA Human Factors Guidance, IEC 62366-1, and the 15-User Validation Rule
Direct comparison of formative usability evaluation and summative human factors validation testing under FDA 2016 Human Factors Guidance and IEC 62366-1:2015+AMD1:2020: study timing, prototype fidelity, the 15-participant-per-group rule, and use error vs. user error.
FDA TAP Program (Total Product Life Cycle Advisory Program): MDUFA V & Breakthrough Devices
Regulatory guide to the FDA CDRH Total Product Life Cycle Advisory Program (TAP) under MDUFA V, Section 515B Breakthrough Devices, and payer alignment.
FDA De Novo Medical Device Classification Request: 21 CFR Part 860 Checklist, Special Controls, and SaMD Strategy
Procedural guide and submission checklist for an FDA De Novo classification request under FD&C Act Section 513(f)(2) and 21 CFR Part 860 Subpart D, detailing mandatory eSTAR structure, Special Controls for novel SaMD and clinical AI, and new predicate creation.
MDCG 2019-11 (Rev. 1) and EU MDR Rule 11: Medical Device Software (MDSW) Qualification, Classification, MDCG 2020-1, MDCG 2023-4, MHRA, and TGA
Technical guide to MDCG 2019-11 (Rev. 1) and EU MDR Annex VIII Rule 11 for Medical Device Software (MDSW), plus MDCG 2020-1, MDCG 2023-4, MHRA, and TGA.
Software of Unknown Provenance (SOUP): IEC 62304, FDA OTS Software & SBOM Compliance
Technical guide to Software of Unknown Provenance (SOUP) under IEC 62304, FDA Off-The-Shelf (OTS) software documentation, and Section 524B SBOM rules.
AAMI TIR45:2023 Guide: Agile Medical Device Software Development, IEC 62304, and FDA Design Controls
Practical engineering guide to FDA-recognized AAMI TIR45:2023, detailing how medical device and SaMD teams align Agile sprints, user stories, and Definition of Done with IEC 62304, ISO 14971 risk management, and FDA 21 CFR 820.30 design controls.
IEC 82304-1:2016 Explained: Standalone Health Software Product Safety, IEC 62304 Integration, and ISO/TS 82304-2
Learn how IEC 82304-1:2016 governs standalone health software and SaMD safety, how it wraps IEC 62304 Clauses 4–9, and what ISO/TS 82304-2 covers.
FDA Digital Health Center of Excellence (DHCoE): Regulatory Scope, Pre-Cert Pilot Findings, and SaMD Oversight
Comprehensive guide to the FDA CDRH Digital Health Center of Excellence (DHCoE), analyzing its regulatory policy role for SaMD and AI/ML devices, key findings from the 2022 Software Precertification (Pre-Cert) Pilot Report, and Predetermined Change Control Plans (PCCPs).
FDA Medical Device Data Systems (MDDS): 21 CFR § 880.6310, Cures Act § 520(o)(1)(D), Mobile Medical Apps, and General Wellness Rules
A regulatory guide to FDA Medical Device Data Systems (MDDS) under 21 CFR § 880.6310 and FD&C Act Section 520(o)(1)(D), comparing Non-Device-MDDS software, Device-MDDS hardware, Mobile Medical Applications enforcement discretion, General Wellness products, and SaMD Unique Device Identification (UDI) labeling.
FDA Total Product Life Cycle (TPLC): CDRH Database, Product Codes, Premarket Clearances, and Postmarket Surveillance
A regulatory and clinical research guide to the FDA Total Product Life Cycle (TPLC) framework and CDRH TPLC database, covering 3-letter product codes, premarket 510(k)/PMA/De Novo summaries, and postmarket MAUDE and recall integration.
ISO/TR 24971:2020 Medical Device Risk Management Guidance: Clause-by-Clause Crosswalk and Annexes A–H
An authoritative reference to ISO/TR 24971:2020 (Medical devices — Guidance on the application of ISO 14971), detailing the structural separation from ISO 14971:2019, the Clauses 4–10 operational crosswalk, and the eight specialized informative annexes covering FMEA/FTA, cybersecurity (Annex F), legacy devices (Annex G), and IVD risk analysis (Annex H).
FDA CSA Guidance: Computer Software Assurance, GPSV, and OTS Software in Medical Devices
Technical guide to FDA Computer Software Assurance (CSA) guidance, General Principles of Software Validation (GPSV), and Off-The-Shelf (OTS) device software.
FDA Clinical Decision Support (CDS) Guidance: The 4 Non-Device CDS Criteria (Section 520(o)(1)(E)) and SaMD Boundaries
How the FDA Clinical Decision Support (CDS) Final Guidance interprets the four Non-Device CDS criteria under Section 520(o)(1)(E) of the FD&C Act.
Use FMEA (uFMEA) and Use-Related Risk Analysis (URRA): PCA Task Decomposition, Critical Task Identification, and the IEC 62366-1 Usability Engineering File
Technical guide to Use FMEA (uFMEA) and Use-Related Risk Analysis (URRA): Perception-Cognition-Action (PCA) decomposition, Critical Tasks, and IEC 62366-1.
FDA Premarket Approval (PMA): 21 CFR Part 814 Class III Pathway, Valid Scientific Evidence, and PMA Supplements
Regulatory guide to the FDA Premarket Approval (PMA) pathway under 21 CFR Part 814 for Class III medical devices and diagnostic AI, covering valid scientific evidence (21 CFR § 860.7), pivotal IDE trials, Modular vs. Traditional PMAs, and post-approval supplements.
Content of Premarket Submissions for Device Software Functions: 2023 FDA Guidance, Basic vs. Enhanced Documentation, and Deliverable Checklist
Complete regulatory engineering checklist for the June 2023 FDA guidance ‘Content of Premarket Submissions for Device Software Functions,’ explaining how Basic and Enhanced Documentation Levels replaced the 2005 Level of Concern framework.
FDA Artificial Intelligence Regulation: AI/ML Medical Devices, Pathways, and GMLP
The FDA regulates artificial intelligence and machine learning (AI/ML)-enabled medical devices through risk-based 510(k), De Novo, and PMA pathways, Good Machine Learning Practice (GMLP) principles, and Predetermined Change Control Plans.
FDA Breakthrough Device Designation: Section 515B Eligibility, 60-Day Q-Sub Review, Sprint Discussions, and CMS Coverage
Regulatory guide to the FDA Breakthrough Devices Program under Section 515B of the FD&C Act (21 U.S.C. § 360e-3), detailing statutory eligibility criteria, 60-day Q-Submission timelines, Sprint Discussions, Data Development Plans, and CMS TCET/NTAP linkages.
FDA Human Factors Guidance: Critical Tasks, Use-Related Risk Analysis (URRA), 15-Participant Validation Testing, and HFE Report Checklist
Regulatory checklist and technical guide to the FDA guidance ‘Applying Human Factors and Usability Engineering to Medical Devices’: critical task identification, Perception-Cognition-Action (PCA) risk analysis, the 15-participant per user group validation rule, and the 8 HFE report sections.
Software Bill of Materials (SBOM): FDA Section 524B, NTIA Minimum Elements, SPDX, and CycloneDX
Technical guide to Software Bills of Materials (SBOM) in healthcare: FDA Section 524B cyber device rules, NTIA minimum elements, SPDX, CycloneDX, and VEX.
Combination Products: How PMOA Determines the Lead FDA Center
How FDA’s primary mode of action (PMOA) test assigns combination products to CDER, CDRH, or CBER, and how to use the Request for Designation process when jurisdiction is unclear.
eSTAR: FDA’s Structured Submission Template for Medical Devices
eSTAR replaced free-form 510(k) and De Novo submissions with a structured, logic-checked interactive PDF. Here is what it covers, how technical screening differs from Refuse to Accept, and the attachment mistakes that actually trigger a hold.
EU MDR Classification Rules: The 22 Annex VIII Rules That Set a Device’s Class
How EU MDR 2017/745 actually classifies a device: the 22 Annex VIII rules across four rule groups, the transient/short-term/long-term duration bands, and the strictest-rule-governs principle behind the classification rationale.
What Is an Investigational Device Exemption (IDE)?
A plain-language guide to what an Investigational Device Exemption (IDE) is, why it exists, how significant-risk vs. nonsignificant-risk device studies differ, and how IDE relates to IND, 510(k), and PMA.
