Premarket Approval (PMA) and 510(k) Premarket Notification Seminar

Date:

Thu, 03/18/2010 - 7:30am - 5:00pm

Registration Link:

Crowne Plaza Hotel - Palo Alto
4290 El Camino Real
Palo Alto, CA 94306

March 18, 2010

The Premarket Approval (PMA) and 510(k) Premarket Notification Seminar gives 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 is 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 provides valuable insight from a variety of perspectives and gives companies considering submitting a 510(k) or PMA in the future the tools they need to prepare successful submissions.

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

Supporting Organizations

BayBio

BIOCOM

California Healthcare Institute (CHI)

Media Sponsors

The Gray Sheet, IN VIVO, START-UP, medtech insight

Registration Fees

MDMA members: $295
BayBio, BIOCOM and CHI members: $395
Non members: $495

Agenda

Thursday, March 18th
7:30am - 8:0am	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

10:00-10:30am	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
		- Recent Modifications to the Review Process - FDA perspective on successful submissions - E -Filing - Important considerations when modifying a 510(k)

11:45am –1:00pm	Networking Luncheon and The Future of the 510(k) Program Mark Leahey, MDMA President and CEO, will discuss the recent public meetings at FDA and IOM, possible changes to the 510(k) system and how this process may unfold over the next year.

1:00pm – 2:00pm	Premarket Approval (PMA) Process Phil Phillips, President and CEO, Phillips Consulting Group
		- 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

2:00pm – 3:00pm	PMA Review Considerations Diane Minear, Vice President, Medical Devices, The Weinberg Group
		- Points to consider for a successful submission - Recent Modifications to the Review Process - Interactions with ODE staff

3:00pm - 3:30pm	Networking Break

3:30pm – 4:30pm	Clinical Trial Considerations - Compliance oversight Phil Phillips, President and CEO, Phillips Consulting Group
		- 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

4:30pm – 5:00pm	Lessons Learned from the Experts Recap of key issues, insights from the speakers, and Q&A

Member Login

Premarket Approval (PMA) and 510(k) Premarket Notification Seminar

Supporting Organizations

Media Sponsors

Registration Fees

Agenda

7:30am - 8:0am

Registration and Continental Breakfast

8:00am - 8:15am

Welcome and Opening Remarks

8:15am - 9:00am

Overview of 510k and PMA Regulations

9:00am - 10:00am

Format and Content of a 510(k)

10:00-10:30am

Networking Break

10:30am –11:45am

The 510(k) Process Review Considerations

11:45am –1:00pm

Networking Luncheon and The Future of the 510(k) Program

1:00pm – 2:00pm

Premarket Approval (PMA) Process

2:00pm – 3:00pm

PMA Review Considerations

3:00pm - 3:30pm

Networking Break

3:30pm – 4:30pm

Clinical Trial Considerations - Compliance oversight

4:30pm – 5:00pm

Lessons Learned from the Experts