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Regulatory
FDA, EU MDR/IVDR, and global pathways for getting devices to market.
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Popular regulatory terms
510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Breakthrough Device Designation(BDD)
FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.
De Novo Classification Request(De Novo)
Pathway to classify novel low- to moderate-risk devices that lack a predicate.
eSTAR
FDA's interactive PDF template for preparing and submitting 510(k) and De Novo submissions.
EU In Vitro Diagnostic Regulation(IVDR)
Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
EU Medical Device Regulation(MDR)
Regulation (EU) 2017/745 governing medical devices in the European Union.
All Regulatory terms
- 510(k) Premarket Notification(510(k))
- 510(k) Summary vs 510(k) Statement
- 513(g) Request for Information(513(g))
- Abbreviated 510(k)
- Accreditation Scheme for Conformity Assessment(ASCA)
- Additional Condition for Nonprescription Use(ACNU)
- AI Act Conformity Assessment (Medical Devices)
- AI Act Post-Market Monitoring
- AI Act Prohibited Practices
- AI Act Serious Incident Reporting
- AI Act Technical Documentation (Annex IV)
- AI Act Transparency Obligations
- Analytical Performance (IVDR)
- ANVISA(ANVISA)
- Authorized Representative (EU)(EC REP)
- Benefit-Risk Determination
- Breakthrough Device Designation(BDD)
- CE Mark
- Class D Batch Verification (IVDR)
- Class III Device
- Clinical Performance (IVDR)
- Combination Product
- Common Specifications(CS)
- Common Specifications (IVDR)(CS)
- Companion Diagnostic (IVDR)(CDx)
- De Novo Classification Request(De Novo)
- Device Master File(MAF)
- Device Reclassification Petition
- Electronic Instructions for Use(eIFU)
- Emergency Use Authorization(EUA)
- eSTAR
- EU In Vitro Diagnostic Regulation(IVDR)
- EU Medical Device Regulation(MDR)
- EU Reference Laboratory (EURL)(EURL)
- EUDAMED
- FDA Recognized Consensus Standards
- Fundamental Rights Impact Assessment(FRIA)
- General Controls
- General Safety and Performance Requirements(GSPRs)
- General Safety and Performance Requirements (IVDR)(GSPR)
- General-Purpose AI Model(GPAI)
- Genetic Testing Requirements (IVDR Article 4)
- Health Canada Medical Device Licence(MDL)
- High-Risk AI System (EU AI Act)
- Humanitarian Device Exemption(HDE)
- IMDRF
- Importer and Distributor Obligations (EU)
- In-House IVDs (Article 5(5))
- Indications for Use(IFU (statement))
- Instructions for Use(IFU)
- Intended Use
- ISO 20916
- IVDR Conformity Assessment Routes
- IVDR Legacy Device
- IVDR Performance Evaluation
- IVDR Risk Classes A–D
- IVDR Transitional Provisions
- Labeling
- Letter to File(LTF)
- MDR Article 117
- Medical Device Coordination Group Guidance(MDCG)
- Medical Device User Fee Amendments(MDUFA)
- Metrological Traceability (IVDR)
- MHRA / UKCA Marking(MHRA / UKCA)
- Ministry of Food and Drug Safety (Korea)(MFDS)
- Modular PMA
- National Medical Products Administration(NMPA)
- NMPA Innovative Medical Device Pathway
- Notified Body(NB)
- Notified Body Scrutiny (IVDR Class D)
- Performance Study Application (IVDR)
- Person Responsible for Regulatory Compliance(PRRC)
- Pharmaceuticals and Medical Devices Agency(PMDA)
- PMA Supplement Types
- Post-Market Performance Follow-Up (IVDR)(PMPF)
- Post-Market Surveillance Plan (IVDR)
- Predicate Device
- Premarket Approval(PMA)
- Provider and Deployer (EU AI Act)
- Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub)
- Real-Time PMA Supplement Review
- Refuse to Accept(RTA)
- Request for Designation(RFD)
- Safer Technologies Program(STeP)
- Saudi Food and Drug Authority(SFDA)
- Scientific Validity (IVDR)
- Self-Test and Near-Patient Testing (IVDR)
- Special 510(k)(Special 510(k))
- Special Controls
- Substantial Equivalence(SE)
- Summary of Safety and Clinical Performance(SSCP)
- Summary of Safety and Performance (IVDR)(SSP)
- Swissmedic
- Systemic Risk (GPAI)
- Therapeutic Goods Administration(TGA)
- Third-Party Review of 510(k)(3P 510(k))
- UK Responsible Person(UKRP)
- Unique Device Identification(UDI)
- WHO Prequalification (Diagnostics)(WHO PQ Dx)