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Engineering
Biomedical Engineering
Medical Device Design and Regulation
1. Introduction to Medical Device Engineering
2. The Medical Device Lifecycle
3. Regulatory Foundations
4. Medical Device Classification
5. The Design and Development Process
6. Quality Management Systems
7. Risk Management
8. Materials and Biocompatibility
9. Pre-Clinical Testing
10. Clinical Evaluation and Trials
11. Regulatory Submission Pathways
12. Labeling and Instructions for Use
13. Post-Market Surveillance and Activities
14. Specialized Topics in Medical Device Design
11.
Regulatory Submission Pathways
11.1.
Premarket Notification
11.1.1.
Substantial Equivalence
11.1.2.
Predicate Devices
11.1.3.
Traditional 510(k)
11.1.4.
Special 510(k)
11.1.5.
Abbreviated 510(k)
11.1.6.
Review Process and Timelines
11.2.
Premarket Approval
11.2.1.
Requirements for Class III Devices
11.2.2.
Demonstration of Safety and Efficacy
11.2.3.
Modular and Staged PMA
11.2.4.
Advisory Panel Review
11.2.5.
Post-Approval Studies
11.3.
De Novo Classification Request
11.3.1.
Eligibility Criteria
11.3.2.
Submission Process
11.3.3.
Review and Decision
11.4.
Humanitarian Device Exemption
11.4.1.
Definition and Purpose
11.4.2.
Application Process
11.4.3.
Limitations and Requirements
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10. Clinical Evaluation and Trials
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12. Labeling and Instructions for Use