Industry & Applied R&D

Medical device and diagnostics research

Medical device and diagnostics research runs on a regulatory map as much as a scientific one. In the United States, FDA assigns each device to Class I, II or III by risk and intended use: non-exempt Class I and II devices reach the market through a 510(k), novel devices with no predicate through a De Novo request, and Class III devices through premarket approval (PMA). Clinical studies of investigational devices follow the investigational device exemption rules in 21 CFR Part 812, with informed consent under Part 50 and IRB review under Part 56; a significant risk study also needs FDA approval of the IDE, so the IRB's risk determination shapes the project. Since 2 February 2026 the device quality rules in Part 820 are the Quality Management System Regulation, which incorporates ISO 13485:2016, and devices made for IDE studies are not exempt from its design and development requirements. ISO 14155:2020 sets good clinical practice for device investigations, excluding in vitro diagnostics. In the EU, Regulation (EU) 2017/745 covers medical devices, and Regulation (EU) 2017/746 has applied to in vitro diagnostics since 26 May 2022. CMS regulates laboratory testing on humans under CLIA. Researchers draw data from MAUDE, the 510(k) and PMA databases, AccessGUDID and openFDA, report diagnostic accuracy studies against STARD 2015, and look to NIBIB for federal technology-development funding.

Reviewed 5 November 2026 by CASRAI Editorial Board

Sources

FDA: Classify Your Medical Device(read 5 November 2026)
FDA: De Novo Classification Request(read 5 November 2026)
FDA: Investigational Device Exemption (IDE)(read 5 November 2026)
FDA guidance: Significant Risk and Nonsignificant Risk Medical Device Studies (landing page)(read 5 November 2026)
FDA: Quality Management System Regulation (QMSR)(read 5 November 2026)
ISO 14155 (Wikipedia; iso.org returned 403)(read 5 November 2026)
EUR-Lex: Regulation (EU) 2017/745 on medical devices (title and recitals)(read 5 November 2026)
European Commission: New regulations (IVDR applicable 26 May 2022)(read 5 November 2026)
CMS: Clinical Laboratory Improvement Amendments (CLIA)(read 5 November 2026)
EQUATOR Network: STARD 2015(read 5 November 2026)
FDA MAUDE database(read 5 November 2026)
FDA 510(k) Premarket Notification database(read 5 November 2026)
FDA Premarket Approval (PMA) database(read 5 November 2026)
NLM AccessGUDID(read 5 November 2026)
FDA: Unique Device Identification System (UDI System)(read 5 November 2026)
openFDA: device API endpoints(read 5 November 2026)
NIBIB: About NIBIB(read 5 November 2026)

Field at a glance

Standards and formats

FDA device classification (Class I, II, III): FDA classifies about 1,700 generic device types by risk and intended use; the class decides whether a 510(k) or a PMA is needed.Website ↗ · Our guide →
Investigational device exemption (21 CFR Part 812): Lets an investigational device be used in a clinical study to collect safety and effectiveness data; needs an IRB-approved plan, consent and investigational labelling.Website ↗ · Our guide →
FDA guidance: Significant Risk and Nonsignificant Risk Medical Device Studies: FDA guidance (January 2006) on telling SR from NSR device studies and on the IRB's role in making the risk determination.Website ↗ · Our guide →
De Novo classification request: FDA's risk-based route for novel devices with no legally marketed predicate; a granted device can serve as a predicate for later 510(k)s.Website ↗ · Our guide →
Quality Management System Regulation (21 CFR Part 820): Effective 2 February 2026, it incorporates ISO 13485:2016 by reference; devices made under an IDE are not exempt from its design and development requirements.Website ↗ · Our guide →
ISO 14155:2020 Clinical investigation of medical devices for human subjects: Good clinical practice for designing, conducting, recording and reporting device investigations for regulatory purposes; it does not cover IVDs.Website ↗ · Our guide →
Regulation (EU) 2017/745 on medical devices (EU MDR): The EU medical devices regulation, which repealed Directives 90/385/EEC and 93/42/EEC; its recitals point to ISO 14155 for clinical investigation practice.Website ↗ · Our guide →
STARD 2015: Reporting guideline for diagnostic accuracy studies, published in BMJ, Radiology and Clinical Chemistry, so readers can judge bias and generalisability.Website ↗ · Our guide →

Archives, facilities and data

MAUDE (Manufacturer and User Facility Device Experience): FDA database of mandatory and voluntary medical device reports over the last ten years, updated monthly; searches return up to 500 records.Website ↗ · Our guide →
FDA 510(k) Premarket Notification database: Searchable 510(k) records by product code, review panel, applicant, decision and clinical-trial status, with downloadable files.Website ↗ · Our guide →
FDA Premarket Approval (PMA) database: Searchable PMA records for Class III devices, including supplements, advisory committee and cleared or approved IVD products.Website ↗ · Our guide →
AccessGUDID (NLM): Public search and full download of device identification data that labelers submit to FDA's GUDID, with an API and GMDN fields.Website ↗ · Our guide →
FDA Unique Device Identification (UDI) System: FDA system to identify devices from manufacture to patient use; labelers submit device records to GUDID by web entry or HL7 SPL upload.Website ↗ · Our guide →
openFDA device API: Programmatic access to FDA device data: 510(k), PMA, classification, adverse events, recalls, UDI and registrations and listings.Website ↗
CLIA (Clinical Laboratory Improvement Amendments): CMS programme regulating laboratory testing performed on humans in the US, about 320,000 laboratory entities, with State Survey Agencies doing most of the work.Website ↗ · Our guide →

Funders and programmes

National Institute of Biomedical Imaging and Bioengineering (NIBIB): NIH institute whose mission is to transform understanding of disease through technology development, funding biomedical imaging and engineering research.Website ↗

Societies

Association for the Advancement of Medical Instrumentation (AAMI): Health technology body that publishes standards and technical reports through technical committees and runs training and certification.Website ↗
Biomedical Engineering Society (BMES): Professional home for biomedical engineers and bioengineers, with over 6,700 members and four journals, including Annals of Biomedical Engineering.Website ↗

Journals

IEEE Transactions on Biomedical Engineering (TBME): IEEE EMBS journal for engineering methods with biomedical applications, including clinical studies with engineering contributions.Website ↗
Clinical Chemistry (ADLM): Oxford-published journal of the Association for Diagnostics and Laboratory Medicine, covering laboratory medicine and diagnostics.Website ↗

Preprints and indexes

medRxiv: openRxiv preprint server for medical and health sciences; screened but not peer reviewed, and preprints should not guide clinical practice.Website ↗

73 pages across 8 topic areas

Laboratory Compliance & Quality

21 CFR Part 58: GLP Requirements for Nonclinical Studies
How 21 CFR Part 58 governs nonclinical safety studies: the study director's single-point authority, quality assurance unit independence, protocol and…
21 CFR Part 820: Subpart-by-Subpart Map and QMSR Transition Status
Part 820 is now the QMSR. A subpart-by-subpart map of where every legacy Quality System Regulation requirement went, what DMR, DHR and DHF are called…
Class IIa Medical Devices Under EU MDR: Conformity Assessment, Notified Body Scope, and PSUR Requirements
The EU MDR obligations specific to Class IIa devices: which conformity assessment route applies (Annex IX vs Annex XI Part A), how much technical docu…
Cleanroom Classifications: ISO 14644-1 and the FED-STD-209E Equivalents
The full ISO 14644-1 particle-limit table for ISO Class 1-9, the legacy FED-STD-209E Class 1/10/100/1,000/10,000/100,000 equivalents, and how a class…
CLIA Certification: Certificate Types, Complexity Categories, and Whether Your Lab Needs One
A guide to CLIA certification under 42 CFR Part 493: the five certificate types, waived/moderate/high complexity categories, and the research-lab exem…
Clinical Evaluation Report (CER) Under EU MDR: Structure, Evidence Sufficiency, and the Equivalence Route
What a clinical evaluation report (CER) must contain under MDR Article 61 and Annex XIV Part A, the MEDDEV 2.7/1 Rev 4 structure notified bodies still…
Complaint Handling for Medical Devices: Intake, Reportability, and the Complaint File
A walkthrough of medical device complaint handling: what counts as a complaint, controlled intake, the MDR/EU MDR vigilance reportability decision, 82…
Computer System Validation (CSV): GAMP 5, IQ/OQ/PQ, and 21 CFR Part 11
What computer system validation actually requires for regulated laboratory systems: the GAMP 5 risk-based approach, GAMP software categories and the c…
Design Controls for the Medical Device Industry
Design controls turn a device concept into a verified, validated design ready for production: planning, testable inputs, genuine outputs and how they…
Design History File (DHF): What Belongs In It, and What Doesn't
A DHF documents how a device was designed, not how it was built or that a specific unit was built correctly. Here is what actually belongs in one, wha…
Document Control Procedure: The Six-Stage Lifecycle
How a document control procedure governs draft, review, approval, distribution, revision, and withdrawal for controlled documents in a GxP quality sys…
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 screen…
EU Authorised Representative for Medical Devices: The MDR Article 11 Mandate, Tasks, and Liability
What MDR Article 11 requires from a non-EU manufacturer's EU authorised representative: mandate contents, minimum tasks, technical documentation acces…
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,…
EU MDR Compliance: What Changed from the MDD
A delta view of EU MDR (2017/745) against the Medical Device Directive it replaced: the PRRC role, EUDAMED, UDI, new Annex VIII classification rules,…
EU MDR Technical Documentation: The Annex II/III Dossier, Section by Section
A section-by-section walkthrough of what belongs in the EU MDR Annex II technical documentation dossier, how the Annex III PMS plan fits alongside it,…
EUDAMED: Module-by-Module Status, What Is Mandatory Now, and the SRN Registration Sequence
EUDAMED rolls out module by module. Which of the six are mandatory, which are proposed, and the actor/SRN, UDI-DI and certificate registration sequenc…
FDA Guidance on Biocompatibility: ISO 10993 Explained
How FDA's biocompatibility guidance applies ISO 10993-1's risk-based framework to 510(k), PMA, De Novo, IDE, and HDE submissions -- including how to c…
FDA Premarket Cybersecurity for Medical Devices: Section 524B, SBOM, and Threat Modeling
What FDA's premarket reviewers actually check under Section 524B: the cyber device test, the SBOM, the secure product development framework, threat mo…
Field Safety Corrective Action (FSCA): FSCA vs Recall vs Field Safety Notice, and the EU/US Cross-Walk
An FSCA is not a recall and a recall is not a field safety notice. The decision criteria, the conditional EU MDR Article 87 notification clocks, the A…
GxP Compliance: What GLP, GCP, GMP, and GDP Actually Require
GxP is an umbrella term for GLP, GCP, GMP, GDP, and related "Good ... Practice" frameworks. This guide explains what they share, which one applies to…
Health Canada Medical Device Licence (MDL) and MDALL
How Health Canada’s Medical Device Licence (MDL) system works: the four device classes, the MDSAP certification requirement, how the MDALL public data…
IEC 62304: Software Safety Classes, Lifecycle Deliverables, and SOUP Requirements
A clause-level map of IEC 62304 Edition 1.1: what Amendment 1:2015 changed about software safety classification, which deliverables each of classes A,…
ISO 13485 Certification: Scope, Stages and Audit Preparation
What the ISO 13485 certification process actually requires: how the scope statement on your certificate is fixed, the IAF MD 9 audit-day table your qu…
ISO 13485: Medical Device Quality Management Systems Explained
ISO 13485:2016 is the standalone international standard for medical-device quality management systems. A clause-by-clause walkthrough of what each req…
ISO 14971: The Risk Management File, Benefit-Risk Determination, and the ISO/TR 24971 Cross-Walk
ISO 14971:2019 requires a traceable risk management file, not a risk table. What clause 4.5 must contain, how clause 7.4 and clause 8 benefit-risk det…
IVDR (EU 2017/746): Classification, Notified Body Requirements, and Transition Deadlines
How EU IVDR (Regulation 2017/746) classifies in vitro diagnostics into Class A-D, why most devices now need Notified Body conformity assessment instea…
Laboratory Developed Tests: Current FDA Regulatory Status
FDA oversight of laboratory developed tests (LDTs) changed twice in under two years: a May 2024 final rule extending device regulation to LDTs was vac…
MDSAP: The Medical Device Single Audit Program, Explained
How MDSAP actually works: the three membership tiers and what each one really accepts, the seven-process audit model auditors follow in sequence, and…
PMCF Plan Under EU MDR Annex XIV Part B: Structure, Study Triggers, and the PSUR Link
How to build a PMCF plan that satisfies MDR Annex XIV Part B: the seven MDCG 2020-7 sections, when literature review alone is defensible, when a dedic…
Post-Market Surveillance (PMS) Plan: Structure, Data Sources, and How It Differs From PMCF
What an EU MDR post-market surveillance plan must contain under Article 83 and Annex III, the real data sources that feed it, how it differs from FDA'…
Shelf Life and Packaging Validation for Medical Devices
How ISO 11607 packaging validation and ASTM F1980 accelerated aging combine under design controls to support a defensible medical device shelf-life cl…
Software as a Medical Device (SaMD): Definition, Classification, and Regulatory Pathways
Before any FDA pathway question comes a prior one: is the software a device at all? The 21st Century Cures Act section 3060 carve-outs — clinical deci…
Sterility Assurance Level (SAL): What SAL 10⁻⁶ Actually Means
SAL 10^-6 is a statistical target, not a guarantee: the probability of one surviving organism per million sterilized units. This guide covers what the…
UDI Labeling and GUDID Submission: The Practical Workflow
The GUDID submission mechanics behind UDI labeling: DUNS-based account setup, the Web Interface vs. HL7 SPL submission routes, the required data attri…
What Is a Medical Device?
A plain-language, legally grounded answer to what counts as a medical device under FDA's definition, how it differs from a drug, biologic, or IVD, and…
What Is an In Vitro Diagnostic (IVD)? A Research-Administration Guide
A plain-language guide to in vitro diagnostics (IVDs) — what they are, how they differ from therapeutic medical devices, how FDA and EU IVDR regulate…
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 studie…
What Is Medical Device Cybersecurity?
Medical device cybersecurity means protecting connected, software-driven devices from vulnerabilities that could affect patient safety -- and why FDA…

Clinical Research Administration

21 CFR: What Title 21 of the Code of Federal Regulations Covers
A routing guide to Title 21 of the Code of Federal Regulations: how CFR citations are structured, and which Part governs electronic records, informed…
AI Reporting Guidelines: CONSORT-AI, TRIPOD+AI, DECIDE-AI and the Rest
A decision guide to the AI-specific reporting-guideline family: which of CONSORT-AI, SPIRIT-AI, TRIPOD+AI, DECIDE-AI and CLAIM applies to your study s…
FDA 510(k) Premarket Notification: A Guide
A guide to the FDA 510(k) premarket notification pathway: the substantial equivalence standard, device classification (Class I/II/III), how 510(k) dif…
FDA AI Guidance: The Regulatory Framework for Artificial Intelligence in Drug Development and Medical Devices
A guide to FDA's two parallel AI guidance tracks: CDRH's SaMD AI/ML and PCCP framework for medical devices, and CDER/CBER's draft guidance on AI in dr…
FDA Human Factors and Usability Engineering Guidance for Medical Devices
FDA's human factors and usability engineering guidance requires use-related risk analysis and formative/summative usability testing for medical device…
FDA Medical Device Regulations: Classification, 510(k), and PMA Pathways
A guide to the FDA medical device regulatory framework: risk-based device classification (Class I/II/III), the 510(k) substantial-equivalence pathway,…
FDA Predetermined Change Control Plans (PCCP) for Adaptive AI: What to Include
How to draft an FDA Predetermined Change Control Plan (PCCP) for an AI-enabled device: the three required components (Description of Modifications, Mo…
STARD, STARD-AI and TRIPOD+AI: Reporting Diagnostic Accuracy and Prediction Studies
A working comparison of the STARD 2015, STARD-AI, and TRIPOD+AI reporting checklists for diagnostic-accuracy and AI/ML prediction-model studies: what…

Laboratory Operations & Safety

Implantable Neurostimulator: Systems and Standards
A technical overview of implantable neurostimulators, covering active hardware architecture, 21 CFR classification, ISO 14708-3 safety, and CT scan pr…
Neuromodulation Device: Types, Components and FDA Classification
Neuromodulation devices explained: implanted types with first FDA approval year, lead and generator layout, and Class II vs III under 21 CFR Part 882.…
Orthopedic Implants: Types, Materials and Rules
A technical guide to orthopedic implants, FDA 21 CFR Part 888 classifications, ASTM biomaterial standards, stress shielding, and hospital supply logis…
Point-of-Care Testing (POCT): Definition, Examples, and How It Differs From Laboratory Testing
Point-of-care testing (POCT) is diagnostic testing performed at or near the patient with results available in minutes. This guide covers the operation…
Radiology Artificial Intelligence: Uses and Rules
A guide to radiology artificial intelligence covering FDA regulations, GMLP standards, clinical imaging workflows, and multisociety governance framewo…
Sterilization Validation: IQ/OQ/PQ Across Steam, EtO, and Radiation Methods
Sterilization validation proves, through IQ/OQ/PQ, that a sterilization process reliably achieves sterility before it goes into routine use. This guid…
UDI Medical Device: FDA Unique Device Identifier Requirements Explained
What a medical device UDI is, the FDA rule (21 CFR Part 830) and GUDID database behind it, who issues device identifiers, and why procurement and supp…

Laboratory Equipment & Instrumentation

ASTM F1886: Visual Seal Inspection of Medical Packaging
ASTM F1886 explained: what the visual packaging integrity method covers, which edition to cite, its limits, and questions to ask a lab.…
Crescent Blade (Crescent Knife): Ophthalmic Types and Specs
What an ophthalmic crescent blade is, its FDA classification (HNN, Class 1), and how to read width, bevel, protection and single-use fields in device…
Dental Handpiece Types: High-Speed, Low-Speed, Electric and Couplings Explained
Dental handpiece types named by the CDC, how 2-hole and 4-hole couplings differ in one FDA record, and the reprocessing checklist for clinic supply de…
Hi-Lo Bed: What It Is, FDA Classes and Medicare Codes
What a hi-lo bed is, how the FDA classifies height-adjustable hospital beds, and how Medicare treats fixed, variable and electric height beds.…
ISO 13485 vs. ISO 9001: Which Applies to a Medical Device DistributorComparison
ISO 13485 explicitly covers device storage and distribution as a certifiable scope; ISO 9001 is a generic QMS with no device-specific content. What th…
What Is a Colposcope? Parts, Magnification, and Regulation
A colposcope is a low-magnification device for viewing the cervix. Parts, 3x-15x magnification and US Class II status explained from CFR and UNFPA.…

Grants Management & Research Funding

FDA MDDT Program: Qualification & Guidelines
Comprehensive guide to the FDA Medical Device Development Tools (MDDT) program: tool categories, Context of Use, two-phase qualification, and premarke…
MDCG Guidance: EU MDR & IVDR Framework
A guide to MDCG guidance under EU MDR and IVDR, detailing working groups, legal status, compliance workflows, and notified body evaluation standards.…
MDIC: Medical Device Innovation Consortium Guide
A research guide to the Medical Device Innovation Consortium (MDIC), covering public-private regulatory science, working group eligibility, and FDA to…
MDUFA: Medical Device User Fee Amendments Guide
A compliance guide to the Medical Device User Fee Amendments (MDUFA), covering MDUFA V commitments, Small Business Determination waivers, and payment…

Research Methods & Statistics

Medical Device Clinical Trials: Design & Phases
Comprehensive guide to medical device clinical trials: study stages, pivotal trial designs, IDE compliance under 21 CFR 812, ISO 14155 GCP, and key co…
Spectrum Bias: Why a Test's Published Sensitivity Won't Hold in Your Patient Mix
Sensitivity and specificity are not fixed properties of a test -- they depend on the disease spectrum of the population it was validated in. This guid…
Verification Bias in Diagnostic Accuracy Studies
Verification (work-up) bias happens when the reference standard isn't applied to all index-test-negative patients, inflating apparent sensitivity and…
What Is Medical Imaging? Research Areas, Funding, and Career Paths
A comprehensive guide to medical imaging: what it studies, its major sub-disciplines, the NIH institutes that fund imaging research, common research m…

Scholarly Publishing

FDA De Novo Database: Search Guide & Records
A guide to the FDA De Novo database, covering search parameters, Decision Summaries, newly established product codes, and regulatory benchmarking.…
IMDRF Codes: Adverse Event Terminology Guide
Complete guide to IMDRF codes for medical device adverse event reporting, covering FDA 3500A integration, EU MIR vigilance, Annex A, and search tools.…
QUADAS-2: Assessing Risk of Bias in Diagnostic Accuracy Studies
QUADAS-2 assesses risk of bias and applicability across four domains — patient selection, index test, reference standard, and flow and timing — using…

Patient Safety & Infection Prevention

Low-Temperature Sterilization Method Selection: EtO vs. VHP vs. Ozone
Choosing among ethylene oxide, vaporized/plasma hydrogen peroxide, and ozone for heat- or moisture-sensitive instruments — a decision matrix by materi…
Safe Medical Devices Act Reporting Duties: The User-Facility Compliance Checklist
What the Safe Medical Devices Act requires of hospitals: device-related death and serious-injury reports, the 10-workday clock, and the annual FDA sum…

Key terms

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