Global Markets

Regulatory41

• 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)
• Breakthrough Device Designation(BDD)
• CE Mark
• Class III Device
• Common Specifications(CS)
• De Novo Classification Request(De Novo)
• eSTAR
• EU In Vitro Diagnostic Regulation(IVDR)
• EU Medical Device Regulation(MDR)
• FDA Recognized Consensus Standards
• General Controls
• General Safety and Performance Requirements(GSPRs)
• Humanitarian Device Exemption(HDE)
• IMDRF
• Importer and Distributor Obligations (EU)
• IVDR Risk Classes A–D
• MDR Article 117
• Medical Device Coordination Group Guidance(MDCG)
• Medical Device User Fee Amendments(MDUFA)
• MHRA / UKCA Marking(MHRA / UKCA)
• 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)
• Premarket Approval(PMA)
• Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub)
• Refuse to Accept(RTA)
• Request for Designation(RFD)
• Safer Technologies Program(STeP)
• Special Controls
• 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)

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 & Trials4

• Clinical Evaluation Report(CER)
• Clinical Investigation Plan(CIP)
• Early Feasibility Study(EFS)
• Investigational Device Exemption(IDE)

Software & AI3

• EU AI Act
• Predetermined Change Control Plan(PCCP)
• Total Product Lifecycle(TPLC)

Manufacturing1

• Pre-Approval Inspection(PAI)

Post-Market12

• 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)
• Trend Reporting (MDR/MIR)

Reimbursement3

• Joint Clinical Assessment(JCA)
• Transitional Coverage for Emerging Technologies(TCET)
• Transitional Coverage for Emerging Technologies(TCET)

Commercialization1

• Pre-Submission Meeting(Q-Sub)

Other ecosystems