March 26, 2009
The Conference Center at Waltham Woods
860 Winter Street
Waltham, MA 02451
 
The Premarket Approval (PMA) and 510(k) Premarket Notification Seminar gave attendees a chance to learn the regulations governing 510(k) and PMA premarket submissions from leading FDA attorneys, industry representatives, and FDA officials. The seminar was designed to help companies understand the technical requirements of submissions, provide practical advice on how to prepare them, help manage and maximize communications with FDA, and avoid fraud and abuse in clinical trials. The program provided valuable insight from a variety of perspectives and gave companies considering submitting a 510(k) or PMA in the future the tools they need to prepare successful submissions.

The Seminar was pre-approved by RAPS as eligible for up to 6 credits towards a participant's RAG recertification upon full completion.

Agenda

Thursday, March 26th

7:30am - 8:00am

Registration and Continental Breakfast

8:00am - 8:15am

Welcome and Opening Remarks
Mark Leahey, President & CEO, MDMA

8:15am - 9:00am

Overview of 510k and PMA Regulations
John Manthei, Partner, Latham & Watkins LLP

• Purpose of a 510(k)
• Types of 510(k)s
• Definition of "substantial equivalence"
• De Novo
• Purpose of a PMA
• Types of PMAs

9:00am - 10:00am

Format and Content of a 510(k)
Mark Gordon, Vice President, Global Regulatory Advocacy and Policy, Boston Scientific Corporation

• Information required by FDA regulations
• Communicating with FDA prior to submission
• Selecting a predicate device
• Obtaining and presenting data in support of a 510(k)
• Case study

Maximizing Your 510(k) after Clearance
Modifications to your cleared intended use: When are new submissions required?

• Device Modifications

10:00am –10:30am

Networking Break

10:30am –11:45am

The 510(k) Process Review Considerations
Heather Rosecrans, Director of 510(k) Staff, Office of Device Evaluation, Center for Devices and Radiological Health

• Review considerations
  • Intended use and predicate devices
  • Technology and use of data
  • Safety and efficacy questions
• Review Process
• FDA perspective on successful submissions
• E-Filing
• Important considerations when modifying a 510(k)

11:45am –12:30pm

Networking Lunch

12:30pm – 1:30pm

Premarket Approval (PMA) Process
Phil Phillips, Director, Medical Device Practice, Becker and Associates Consulting, Inc.

• Content requirements
• Determining the indications for use
• Drafting summaries of safety, effectiveness and labeling
• Manufacturing information
• Organizing your submission: dos and don'ts
• Generating pre-clinical and clinical data
• PMA Supplements
• Case Study

1:30pm – 2:30pm

PMA Review Considerations

Nicole L. Wolanski, Director, PMA Program, Office of Device Evaluation, Center for Devices and Radiological Health     

• Points to consider for a successful submission
• Review Process
• Interactions with ODE staff

2:30pm - 3:00pm

Networking Break

3:00pm – 4:00pm

Clinical Trial Considerations - Compliance oversight
Phil Phillips, Director, Medical Device Practice, Becker and Associates Consulting, Inc

• FDA's investigation device regulations (IDE)
• Good labor practices
• Ensuring adequate informed consent
• Fulfilling sponsor, monitor, and investigator requirements
• Pre IDE meeting: maximizing you time with FDA
• Complying with new registry and results database
• Avoiding Fraud and Abuse

4:00pm –  5:00pm

Lessons Learned from the Experts
Recap of key issues, insights from the speakers, and Q&A