Global Markets

Regulatory73

• 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 Prohibited Practices
• Analytical Performance (IVDR)
• ANVISA(ANVISA)
• Authorized Representative (EU)(EC REP)
• Breakthrough Device Designation(BDD)
• CE Mark
• Class D Batch Verification (IVDR)
• Class III Device
• Clinical Performance (IVDR)
• Common Specifications(CS)
• Common Specifications (IVDR)(CS)
• Companion Diagnostic (IVDR)(CDx)
• De Novo Classification Request(De Novo)
• Device Master File(MAF)
• Device Reclassification Petition
• Emergency Use Authorization(EUA)
• eSTAR
• EU In Vitro Diagnostic Regulation(IVDR)
• EU Medical Device Regulation(MDR)
• EU Reference Laboratory (EURL)(EURL)
• FDA Recognized Consensus Standards
• General Controls
• General Safety and Performance Requirements(GSPRs)
• General Safety and Performance Requirements (IVDR)(GSPR)
• Genetic Testing Requirements (IVDR Article 4)
• High-Risk AI System (EU AI Act)
• Humanitarian Device Exemption(HDE)
• IMDRF
• Importer and Distributor Obligations (EU)
• In-House IVDs (Article 5(5))
• IVDR Conformity Assessment Routes
• IVDR Legacy Device
• IVDR Performance Evaluation
• IVDR Risk Classes A–D
• IVDR Transitional Provisions
• MDR Article 117
• Medical Device Coordination Group Guidance(MDCG)
• Medical Device User Fee Amendments(MDUFA)
• Metrological Traceability (IVDR)
• MHRA / UKCA Marking(MHRA / UKCA)
• 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)
• 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)
• Scientific Validity (IVDR)
• Self-Test and Near-Patient Testing (IVDR)
• Special Controls
• Summary of Safety and Clinical Performance(SSCP)
• Summary of Safety and Performance (IVDR)(SSP)
• Swissmedic
• Therapeutic Goods Administration(TGA)
• Third-Party Review of 510(k)(3P 510(k))
• UK Responsible Person(UKRP)

Quality & Risk5

• FDA Form 483
• Medical Device Single Audit Program(MDSAP)
• Quality Management System Regulation(QMSR)
• Quality System Regulation(QSR / 21 CFR 820)
• Warning Letter

Cybersecurity3

• IMDRF Principles and Practices for Medical Device Cybersecurity
• Refuse to Accept (Cybersecurity)(RTA (cyber))
• Section 524B of the FD&C Act(524B)

Clinical & Trials7

• Clinical Evaluation Plan(CEP)
• Clinical Evaluation Report(CER)
• Clinical Investigation Plan(CIP)
• Early Feasibility Study(EFS)
• IDE Annual Progress Report
• Investigational Device Exemption(IDE)
• Performance Study (IVDR)

Software & AI4

• EU AI Act
• Medical Device Data System(MDDS)
• Predetermined Change Control Plan(PCCP)
• Total Product Lifecycle(TPLC)

Manufacturing1

• Pre-Approval Inspection(PAI)

Post-Market13

• 5-Day Report
• Electronic Medical Device Reporting(eMDR)
• FDA Recall Classifications I, II, III
• Field Action vs Recall
• Global Unique Device Identification Database(GUDID)
• Manufacturer Incident Report(MIR)
• Medical Device Recall
• Medical Device Reporting (FDA)(MDR)
• Periodic Safety Update Report(PSUR)
• Post-Market Performance Follow-up(PMPF)
• PSUR (IVDR Specific)
• Section 522 Postmarket Surveillance(Section 522)
• Trend Reporting (MDR/MIR)

Market Segments1

• Single-Use Device(SUD)

Reimbursement3

• CMS IDE Coverage (Category A & B)
• Joint Clinical Assessment(JCA)
• Transitional Coverage for Emerging Technologies(TCET)

Commercialization1

• Pre-Submission Meeting(Q-Sub)

Other ecosystems