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Public Workshop - Division of Cardiovascular (DCD) 30-Day Notices and Annual Reports Workshop, August 28, 2012

Wed, 08/08/2012 - 12:00am
U.S. Food & Drug Administration

The Food and Drug Administration (FDA) is announcing the following public workshop entitled “Division of Cardiovascular Devices (DCD) 30-Day Notice and Annual Report." This workshop will be co-sponsored with Advanced Medical Technology Association (AvaMed). The purpose of this workshop is to discuss details of the reporting requirements for both 30-Day Notices and Annual Reports for cardiovascular devices.

Date, Time and Location

This workshop will be held August 28, 2012, beginning at 8:00 am – 5:00 pm at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center (Great Room, Sections B&C)
Silver Spring, MD 20993

The workshop will be webcasted.

Draft Agenda Topics

  • The role of risk assessment in evaluating manufacturing changes
  • Equipment/software changes
  • Moves/relocations
  • Supplier changes
  • Submission types and conversions
  • Best practices for submissions

Registration to Attend the Workshop

Registration will be available soon.

Contact Us

For questions regarding workshop content please contact:

Lindsay K. Pack
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., WO-66, Rm. 1260
Silver Spring, MD 20993
301-796-5214
email: Lindsay.pack@fda.hhs.gov

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