FDA REGULATIONS REQUIRE A PREMARKET NOTIFICATION ( 2013 - Device Changes--The Critical Components of Analyzing and Documenting the Need or No Need for Additional 510(k) Clearance

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Category Medical Device ; Pharma

Deadline: April 15, 2013 | Date: April 16, 2013

Venue/Country: Houstan, U.S.A

Updated: 2013-02-09 00:30:12 (GMT+9)

Call For Papers - CFP

FDA regulations require a premarket notification (510(k) submission when a medical device is significantly changed or modified in design, components, method of manufacturer, or intended use.FDA may view a significant change differently than a manufacturer, which could pose future risk of enforcement. This webinar will review necessary steps in determining whether a change in a device may be considered a “significant change” or not as well as the importance of documenting this process.

Description of the topic :

During this webinar, participants will be provided with an understanding of the procedures in analyzing whether additional 510(k) clearance is necessary for a product. We will review the types of modifications and necessary questions to ask to determine whether an additional 510(k) is necessary, including:

1. Labeling changes

2. Technology, engineering, and performance changes

Materials changes

Areas covered in the session

Types of device chanfes that do and do not require additional 510(k) clearance

Procedures for analyzing and documenting the need for additional 510(k) clearance.

Who will benefit:

Representatives of manufacturers and marketers of medical devices, including in-house counsel, outside counsel, regulatory affairs personnel, and regulatory consultants.

Webinar Include:

Certificate of Attendance

Get a chance to be part of live Q/A Session with the Expert to ask your toughest question

PDF print only copy of PowerPoint slides

Attend 60 Minutes Live Presentation Online

Faculty:

J. Mason Weeda devotes his practice to a blend of regulatory and litigation matters, principally representing medical device, biologics, pharmaceutical and food manufacturers, distributors and importers.

Mr. Weeda previously worked in various sales and marketing capacities for a biologics manufacturer and a laboratory that provided neurogenetic diagnostic testing. Mr. Weeda is a former law clerk to The Honorable Terrence J. McGann, of the Circuit Court for Montgomery County, Maryland, where he was provided with vast exposure to numerous areas of litigation. Mr. Weeda then specialized in litigation at a boutique law firm in Maryland, where he handled domestic relations cases. This dynamic background of litigation skills and sales and marketing experience affords Mr. Weeda a unique and beneficial perspective in assessing and resolving regulatory matters.

About Speaker

Mr. Terman is a principal at OFW Law. He was born in Washington, DC, and received his B.S. in economics in 1973 from the University of Maryland where he was Phi Kappa Phi and his J.D. in 1976, also from the University of Maryland. Mr. Terman was admitted to the Maryland Bar in 1976 and the District of Columbia Bar in 1979. He is currently a member of the District of Columbia Bar.

Speaker : Stephen D. Terman

Product ID : F62206

Schedule Date :

Tuesday, April 16, 2013

duration : 01:00 to 02:00 PM EST

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