Regulated Pathways

Regulatory59

• 510(k) Premarket Notification(510(k))
• 513(g) Request for Information(513(g))
• Abbreviated 510(k)
• Accreditation Scheme for Conformity Assessment(ASCA)
• ANVISA(ANVISA)
• Authorized Representative (EU)(EC REP)
• Benefit-Risk Determination
• Breakthrough Device Designation(BDD)
• CE Mark
• Class III Device
• Combination Product
• Common Specifications(CS)
• De Novo Classification Request(De Novo)
• Electronic Instructions for Use(eIFU)
• eSTAR
• EU In Vitro Diagnostic Regulation(IVDR)
• EU Medical Device Regulation(MDR)
• EUDAMED
• FDA Recognized Consensus Standards
• General Controls
• General Safety and Performance Requirements(GSPRs)
• Health Canada Medical Device Licence(MDL)
• Humanitarian Device Exemption(HDE)
• IMDRF
• Importer and Distributor Obligations (EU)
• Indications for Use(IFU (statement))
• Instructions for Use(IFU)
• Intended Use
• ISO 20916
• IVDR Risk Classes A–D
• Labeling
• Letter to File(LTF)
• MDR Article 117
• Medical Device Coordination Group Guidance(MDCG)
• Medical Device User Fee Amendments(MDUFA)
• MHRA / UKCA Marking(MHRA / UKCA)
• Ministry of Food and Drug Safety (Korea)(MFDS)
• National Medical Products Administration(NMPA)
• NMPA Innovative Medical Device Pathway
• Notified Body(NB)
• Person Responsible for Regulatory Compliance(PRRC)
• Pharmaceuticals and Medical Devices Agency(PMDA)
• Predicate Device
• Premarket Approval(PMA)
• Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub)
• Refuse to Accept(RTA)
• Request for Designation(RFD)
• Safer Technologies Program(STeP)
• Saudi Food and Drug Authority(SFDA)
• Special 510(k)(Special 510(k))
• Special Controls
• Substantial Equivalence(SE)
• Summary of Safety and Clinical Performance(SSCP)
• Swissmedic
• 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)

Cybersecurity1

• Premarket Cybersecurity Submission

Clinical & Trials2

• Clinical Evaluation Report(CER)
• Clinical Investigation Plan(CIP)

Manufacturing1

• Pre-Approval Inspection(PAI)

Post-Market8

• 5-Day Report
• Annual Report (PMA)
• Medical Device Reporting (FDA)(MDR)
• Periodic Safety Update Report(PSUR)
• Post-Market Clinical Follow-up(PMCF)
• Post-Market Performance Follow-up(PMPF)
• PSUR (IVDR Specific)
• Trend Reporting (MDR/MIR)

Reimbursement2

• Transitional Coverage for Emerging Technologies(TCET)
• Transitional Coverage for Emerging Technologies(TCET)

Other ecosystems