Medical Device Compliance Terminology
- 21 CFR Part 807- Establishment Registration
- 21CFR Part 807 - Medical Device Listing
- Abbreviated 510(k)
- Abbreviated 510(k) - Content/Format
- Application Integrity Policy (AIP)
- Application of IDE Regulation on In Vitro Diagnostic devices
- Closing an IDE
- Device Master Record
- Device Master Record - Content
- Device Master Record - Document for Intended Employees
- Device Master Record - Location of Records
- Device Master Records - Record Retention
- Export of Investigational Devices
- IDE Application
- IDE Application - Grounds for Clinical Hold
- IDE Application - Notice of Disapproval or Withdrawal
- IDE Application - Required Elements
- IDE Application- Suggested Format for IDE Submissions
- IDE Application: Common Problems with Original IDE Applications
- IDE Application: Suggested Content for Original IDE Application Cover Letter
- IDE Approval Process
- IDE Approval Process - Nonsignificant Risk Device Studies
- IDE Approval Process- IDE Exempt Investigations
- IDE Approval Process: FDA Action on IDE Applications
- IDE Approval Process: Significant Device Risk Studies
- IDE Early Access: Continued Access
- IDE Early Access: Treatment Use
- IDE Early/Expanded Access
- IDE Early/Expanded Access: Compassionate Use (or Single Patient/Small Group Access)
- IDE Early/Expanded Access: Emergency Research
- IDE Early/Expanded Access: Emergency Use
- IDE Enforcement of Good Clinical Practices (GCP) Regulations
- IDE Financial Disclosure
- IDE Informed Consent
- IDE Institutional Review Boards (IRB)
- IDE Investigator Responsibilities
- IDE Investigator Responsibilities - Device Disposal
- IDE Investigator Responsibilities - Documentation
- IDE Investigator Responsibilities - Financial Disclosure
- IDE Investigator Responsibilities - Nonsignificant Risk Device Studies
- IDE Modifications
- IDE Monitors Responsibilities
- IDE Records: Investigator Records
- IDE Records: Maintenance of Records
- IDE Records: Sponsor Records
- IDE Regulations
- IDE Reports
- IDE Reports: Investigator Annual Progress Reports and Final Reports
- IDE Reports: Suggested Format for IDE Final Report
- IDE Reports: Suggested Format for IDE Progress Report
- IDE Sponsor Responsibilities
- IDE Sponsor Responsibilities - Documentation
- IDE Sponsor Responsibilities - Investigator Agreements
- IDE Sponsor Responsibilities - Labeling
- IDE Sponsor Responsibilities - Monitoring
- IDE Sponsor Responsibilities - Nonsignificant Risk Device Studies
- Implant
- Import and Export of Investigational Devices Non-Tier One Countries
- Import and Export of Investigational Devices
- Import of Investigational Devices
- ISO 14971:2012 for Medical Devices
- Investigational Device Exemption (IDE)
- MDUFA III Fees
- Medical Device Design Control - Design History File
- Medical Device Design Control - Design Output
- Medical Device Design Control - Design Review
- Medical Device Design Control - Design Transfer
- Medical Device Design Control - Design Verification and Validation
- Medical Device Design Control - Quality System
- Medical Device Design Controls - Applicability
- Medical Device Premarket Approval - Data Requirements
- Medical Device Premarket Approval (PMA)
- Medical Device Premarket Notification (510k)
- Medical Device Premarket Notification (510k) - When It is Required
- Medical Device Premarket Notification (510k): Substantial Equivalence
- Medical Device Quality System Regulation (QSR)
- Medical Device Reporting
- Medical Device User Fee Amendments 2012
- Nonsignificant risk device
- PMA Application Methods
- PMA Application Methods - Product Development Protocol
- PMA Application Methods - Traditional PMA
- PMA Application Methods- Modular PMA
- PMA Application Methods-Humanitarian Device Exemption
- PMA Methods- Streamlined PMA
- Pre IDE Process
- Premarket Notification 510(k) - 21 CFR Part 807 Subpart E
- Recordkeeping Requirements for All Exported Investigational Devices
- Significant risk device (SR device)
- Special 510(k)
- Special 510(k)- Content/Format
- Traditional 510(k)
- Transitional Device
- Unanticipated Adverse Device Effect
- Unique Device Identification (UDI)
