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FDA Releases New Final Guidance on Medical Device Reporting Requirements for Manufacturers

  • By: Staff Editor
  • Date: March 08, 2017
  • Source: https://www.fda.gov
Abstract:

FDA Releases New Final Guidance on Medical Device Reporting Requirements for Manufacturers

The US FDA has recently finalized its 2013 draft guidance on the Medical Device Reporting (MDR) requirements for manufacturers. The guidance supersedes the 1997 MDR guidance document. The finalized guidance document addresses the reporting and recordkeeping requirements for device related adverse events and malfunctions.

The guidance requires the submission of three types of MDR reports. These include 30-day (initial) reports [21 CFR 803.10(c). 803.20 and 803.50], 5 - day reports [21 CFR 803.10(c), 803.20 and 803.53] and supplemental reports [21 CFR 803.10(c) and 803.56]. It further details the required information to be included in the each kind of report and the necessary time frame for submissions.

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