What's New - Food, Drug & Devices

The Medical Devices Reporter has undergone several significant enhancements in recent weeks. These enhancements include the following:

  • Updated indexing: The cumulative, topical, and device classification indexes have been updated for better access to the latest developments in the field.
  • New explanation sections created: New explanation sections have been created in the areas of jurisdictional determinations; medical device user fees; human cells, tissue, and cellular and tissue-based products; and reprocessed single-use devices.
  • Revised explanations: Existing explanation sections have been revised as required by recent developments in the field.
  • Court decisions: Dozens of new court decisions have been annotated to appropriate explanation sections.
  • FDA agreements and MOUs: A list and description of all current FDA agreements and Memorandum of Understanding (MOU) have been provided.
  • Contact information: FDA contact information has been updated to include the most current office holders and employees, their mailing addresses, telephone numbers, and e-mail addresses.
  • Regional offices and laboratories: Current FDA regional office, laboratory, and small business contact information has been updated.
  • Advisory committees: Advisory committee information has been updated to include the names of current committee members, a description of their area of expertise, occupation, term of appointment, and mailing address.
  • Forms: Existing FDA forms have been updated with the most current versions and 14 new forms have been added. FDA instructions for preparing these forms have also been provided.
  • Print transfer binder: A transfer binder containing court decisions, proposals, preambles, and guidance notices from 2000 through 2002 has been provided to print subscribers.

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