MDMA 510(k) Workshop: What Every Medical Technology Company Should Know About the 510(k) Process
September 30 , 2005 Burlington, MA |
AGENDA
| FRIDAY 9.30.2005 | ||
| 7:30-8:00 AM | REGISTRATION/CHECK-IN | |
| 8:00-8:45 AM | THE FDA's REGULATION 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 | ||
| 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 | ||
| General 510(k) Principals | ||
| -Determining "Substantial Equivalence" | ||
| -IDE's | ||
| -Difference Between 510(k)s and PMAs | ||
| 8:45-9:45 AM | DEVELOPING AND SUBMITTING YOUR 510(k) - Steps in Submitting a 510(k) Carolyne R. Hathaway, Partner, Latham & Watkins LLP |
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| When to Submit a 510(k) | ||
| Selecting a Predicate | ||
| -Same Intended Use | ||
| -Technological Characteristics | ||
| -Supporting Data | ||
| Elements of the 510(k) | ||
| FDA Review and Decision | ||
| 9:45-10:00 AM | BREAK | |
| 10:00-11:00 AM | EXPEDITED REVIEWS Tony Blank, Vice President, Interventional Cardiology & Corporate Regulatory Affairs, Boston Scientific Corporation |
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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, Director, 510(k) Staff, 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 Casey Conry, Project Engineer, Underwriters Laboratories Inc. |
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| 1:00-1:45 PM | CLINICAL TRIAL CONSIDERATIONS John R. Manthei, Partner, Latham & Watkins LLP |
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Investigational Device Exemptions |
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| -"Significant" versus "Non-significant" Risk Devices | ||
| -FDA's Refuse to Accept Policy | ||
| -Effective Use of Communications with FDA | ||
| -IDE Supplements, Requirements, and Exemptions | ||
| -Labeling Requirements | ||
| -Marketing and Promotion Restrictions | ||
| -Investigator Recruitment | ||
| -Advertising and Promotion Restrictions | ||
| 1:45-2:45 PM | DESIGNING CLINICAL TRIALS FOR 510(k) NOTIFICATIONS Karen M. Becker, Ph.D., President and CEO, Becker & Associates Consulting |
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| Business Goals | ||
| Regulatory Considerations | ||
| Trial Design | ||
| Study Execution | ||
| 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) | ||
| -"Indications for Use" | ||
| -Technology, Engineering, and Performance Changes | ||
| -"Letter to File" Requirements | ||