MDMA 510(k) Workshop: What Every Medical Technology Company Should Know About the 510(k) Process
March 8, 2005
The Center Club
Costa Mesa, California
AGENDA
Updated 2.15.2005
| TUESDAY 3.8.2005 |
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| 7:30-8:00 AM | REGISTRATION/CHECK-IN | |
| 8:00-8:45 AM | INTRODUCTION TO FDA's PREMARKET REVIEW OF MEDICAL DEVICES John R. Manthei, Partner, Latham & Watkins LLP |
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| Overview of FDA’s Regulatory Classifications | ||
| Primary Routes to Market: PMA/510(k)s | ||
| General 510(k) Principles | ||
| Exemptions From Filing 510(k)s and Its Impact on Marketing Strategies | ||
| -Class I and Class II Exemptions | ||
| -Custom Device Exemptions | ||
| -Distributors, and Repackagers Exemption | ||
| 8:45-9:45 AM | THE CONTENT OF A 510(k) Carolyne R. Hathaway, Partner, Latham & Watkins LLP |
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| When is a 510(k) Required Prior to Marketing | ||
| Statutory, and Regulatory Required Elements of the 510(k) | ||
| -Selection of Predicate Devices | ||
| -Determining "Substantial Equivalence" | ||
| -Effective Use of Guidance Documents | ||
| Effective Strategies to Manage Communications with FDA | ||
| FDA’s Refuse to Accept Policy | ||
| FDA’s Actions on 510(k)s Submissions | ||
| 9:45-10:00 AM | BREAK | |
| 10:00-11:00 PM | EXPEDITED REVIEWS Morten S. Christensen, Staff Engineer and FDA Office Coordinator, Underwriters Laboratories |
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| 510(k) Paradigm | ||
| Special 510(k)s | ||
| Abbreviated 510(k)s | ||
| Declaration of Conformity with Industry Standards | ||
| 11:00-12:00 PM | PRACTICAL CONSIDERATIONS IN PREPARING 510(k)s: An Agency Perspective Heather Rosecrans, Office of Device Evaluation, Center for Devices and Radiological Health |
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| 12:00-1:00 PM | FDA’s THIRD PARTY REVIEW PROGRAM: Lunch presentation Anil N. Patel, P.E., US Business Manager, Underwriters Laboratories |
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| 1:00-1:45 PM | CLINICAL TRIAL CONSIDERATIONS | |
Investigational Device Exemptions John R. Manthei, Partner, Latham & Watkins LLP |
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| -Content of an IDE | ||
| -Pre-IDE Meetings | ||
| -"Significant" versus "Non-significant" Risk Devices | ||
| -IDE Supplements | ||
| -IDE Exemptions | ||
| -Marketing and Promotion Restrictions | ||
| 1:45-2:45 PM | Designing Your Study To Support a"Substantial Equivalence" Determination David Goodman, MD, Vice President, Medical Devices, The Weinberg Group |
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| -Maximizing Communications With FDA | ||
| -Statistical Considerations | ||
| -Designing Your Trial to Gather Data to Support Center for Medicare and Medicaid Reimbursement – Don’t Do it Twice |
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| 2:45-3:00 PM | BREAK | |
| 3:00-3:30 PM | WHEN A “PREDICATE” ISN’T AVAILABLE – FDA’s De Novo Classification Procedures Michael A. Swit, Esq., Vice President, Life Sciences, The Weinberg Group |
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| Background on FDA’s De Novo Classification Procedures | ||
| When is the De Novo process appropriate? | ||
| Content of a De Novo Application | ||
| Managing Communications With FDA | ||
| 3:30-4:30 PM | MAXIMIZING YOUR 510(k) - Life After Clearance John R. Manthei, Partner, Latham & Watkins LLP |
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| Modifications to Cleared Devices After Marketing | ||
| -Deciding When Changes Require a New 510(k) versus Documenting Changes "To File" | ||
| -"Letter to File" Requirements | ||
| Product Promotions (General vs. Specific Intended Uses) | ||
QUESTIONS?
If you have any questions or need additional information, please email Shannon Scott or call 202.349.7173.