Week 5 Lecture 4 - Regulatory Issues.pptx
5/8/13
Regulatory Issues
Bob Barnes and Marilyn Lombardi 1
FTO – Legal, Regulatory, & Financial Intellectual Property
Regulatory
FDA, etc.
Financial
Reimbursement
Freedom to Operate
Legal
2
1
5/8/13
A Few References to Start * USFDA Overview http://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM283299.pdf
* USFood and Drug Administration http://en.wikipedia.org/wiki/FDA
* Regulatory Basics http://www.stanford.edu/group/biodesign/cgi-‐bin/ebiodesign/index.php/concept-‐selection/ regulatory-‐basics-‐menu
3
Medical Devices Step 2
Step 1 Device Class
510K
PMA
Planning and Work
Exempt
Step 3
4
2
5/8/13
Device Classifications Examples Class I
• Minimal prospective harm • Simple design
• Handheld instruments • Golves
Class II
• Typically non-‐invasive • More complicated • Demonstrate no injury; no harm
• Powered wheelchairs • X-‐ray machines
Class III
• Typically implantable • Therapeutic; life sustaining • Similar device does not exist
• Pacemakers • Breast implants • Replacement heart valves
5
Class I
Class I
• • • •
Exempt -‐ no predicate; no approval Register with FDA Comply with FDA labeling Quality system in place
6
3
5/8/13
Class II
Class II
• Demonstrate similarity to an approved predicate device • Meet Class I requirements • Special controls Labeling Mandatory performance standards Post-‐market surveillance
7
Class III
Class III
• FDA Premarket Approval Process (PMA) • All Class I and II requirements All Life Sustaining Products
• Large multi-‐location • Statistically representative, randomized clinical trials • Multi-‐year • Panel review – all non-‐FDA employees (physicians, statisticians, and other experts
8
4
5/8/13
Class I Exempt
Class II 510K
Weeks & Months $1,000s to $10,000s
Summary
Months & Years $10,000s to $100,000s
Regulatory Issues
Years $100,000s t $1,000,000s
Class III PMA 9
5
Regulatory Issues
Bob Barnes and Marilyn Lombardi 1
FTO – Legal, Regulatory, & Financial Intellectual Property
Regulatory
FDA, etc.
Financial
Reimbursement
Freedom to Operate
Legal
2
1
5/8/13
A Few References to Start * USFDA Overview http://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM283299.pdf
* USFood and Drug Administration http://en.wikipedia.org/wiki/FDA
* Regulatory Basics http://www.stanford.edu/group/biodesign/cgi-‐bin/ebiodesign/index.php/concept-‐selection/ regulatory-‐basics-‐menu
3
Medical Devices Step 2
Step 1 Device Class
510K
PMA
Planning and Work
Exempt
Step 3
4
2
5/8/13
Device Classifications Examples Class I
• Minimal prospective harm • Simple design
• Handheld instruments • Golves
Class II
• Typically non-‐invasive • More complicated • Demonstrate no injury; no harm
• Powered wheelchairs • X-‐ray machines
Class III
• Typically implantable • Therapeutic; life sustaining • Similar device does not exist
• Pacemakers • Breast implants • Replacement heart valves
5
Class I
Class I
• • • •
Exempt -‐ no predicate; no approval Register with FDA Comply with FDA labeling Quality system in place
6
3
5/8/13
Class II
Class II
• Demonstrate similarity to an approved predicate device • Meet Class I requirements • Special controls Labeling Mandatory performance standards Post-‐market surveillance
7
Class III
Class III
• FDA Premarket Approval Process (PMA) • All Class I and II requirements All Life Sustaining Products
• Large multi-‐location • Statistically representative, randomized clinical trials • Multi-‐year • Panel review – all non-‐FDA employees (physicians, statisticians, and other experts
8
4
5/8/13
Class I Exempt
Class II 510K
Weeks & Months $1,000s to $10,000s
Summary
Months & Years $10,000s to $100,000s
Regulatory Issues
Years $100,000s t $1,000,000s
Class III PMA 9
5
