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Types of Communication During Medical Device Submissions Review

This guidance describes four types of communication that occur during the review of medical device submissions: - Acceptance Review Communication for 510(k)s, Original PMAs, Panel-Track PMA Supplements, and Pre-Submissions - Substantive Interaction for 510(k)s, Original PMAs, Panel-Track PMA Supplements, and 180-Day PMA Supplements - Interactive Review - Missed MDUFA Decision Communication for 510(k)s, Original PMAs, and Panel-Track PMA Supplements

  1. Ensure submission is complete and well-organized before initial filing
  2. Include complete contact information in cover letter including alternative contacts
  3. Monitor and meet FDA-specified timeframes for responding to Interactive Review requests
  4. Use email/fax as primary communication tools during Interactive Review
  5. Document all communications during Interactive Review process
  6. Contact FDA lead reviewer/RPM promptly for any clarifications or issues during review
  7. Establish secure email communications with FDA if desired
  8. Have US representative available for foreign companies
  9. Be prepared to participate in meetings/teleconferences if needed for Missed MDUFA Decision Communication
  10. Consider using Pre-Submission Program to obtain FDA feedback before formal submission

Key Considerations

Other considerations

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Original guidance

  • Types of Communication During Medical Device Submissions Review
  • HTML / PDF
  • Issue date: 2014-04-04
  • Last changed date: 2020-03-02
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Biologics
  • ReguVirta summary file ID: 0700f10f81299a58faa33a4965c63149
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