FDA Schedules Three Public Seminars on The Essentials of Medical Device Regulations:

The Food and Drug Administration plans to present a public seminars on FDA medical device regulations to introduce startup and small device manufacturers and their suppliers to the essentials of medical device regulations on three dates during July and August. The seminars to be hosted in three different cities will cover include:

  • Doing business in a regulated industry;
  • Organizational structure of FDA;
  • Overview of the quality system regulation;
  • Design controls;
  • Documents, records, and change control;
  • Purchasing controls and acceptance activities;
  • Production and process control;
  • Corrective and preventive actions;
  • Complaints, medical device reports, corrections, and
  • recalls;
  • Compliance issues;
  • Management responsibility;
  • Interacting with FDA–Where do you go for assistance?
  • General question and answer session;
  • Manufacturers and suppliers–The chain regulatory
  • responsibility;
  • Reimbursement of medical technology;
  • The AdvaMed code of ethics; and
  • Fraud and abuse.

The 2-day seminars to be hosted in cooperation with AdvaMed’s Medical Technology Learning Institute are scheduled on:

  • July 14-15,  2009 in Coronado, CA
  • August 4- 5, 2009 in Nashville, TN and
  • August 12-13, 2009 in San Juan

The registration fee is $650 per person per seminar.  For additional details, see the FDA Announcement in the June 24, 2009 Federal Register.

For More Information

We hope that this information is useful to you. If you need assistance with EMR or other health care technology, privacy or other health care compliance, risk management, transaction or operation concerns, please contact Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer at (214) 270-2402, CStamer@CTTLegal.com or your other favorite Curan Tomko Tarski LLP Partner.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here or e-mailing this information to CStamer@CTTLegal.com.

 ©2009 Cynthia Marcotte Stamer.  All rights reserved.

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