October 1, 1996

2 Min Read
FDA's New MDR Regulations:What Manufacturers Need to Know

Edward M. Basile and Elizabeth A. SchmidtleinBOX 1


FDA's new MDR regulations introduce many important changes to the reporting requirements for manufacturers. The most significant of these are as follows.

  • The new regulations narrow the definition of serious injury, which no longer includes "unanticipated temporary impairment or damage."

  • Manufacturers were previously required to submit MDR reports for most reportable events within five days. The new regulations extend this deadline to 30 days for most reportable events.

  • Manufacturers must submit their MDR reports using FDA form 3500A.

  • When an adverse event involving a device model or family is reported for the first time, manufacturers must submit a baseline report about the device (except for denominator data) using FDA form 3417.

  • Manufacturers are no longer required to automatically report every adverse event merely because the information originated with a health-care professional (i.e., the "per se" rule has been eliminated).

  • Manufacturers must develop, maintain, and implement written MDR procedures, and establish and maintain MDR event files.

As a result of industry criticism, FDA has stayed the effective dates of three controversial provisions of the new MDR regulations. While all other provisions of the new regulations went into effect on July 31, 1996, FDA has proposed to handle the postponed provisions as follows:

  • The new regulations would have required manufacturers to submit denominator data as part of their baseline reports. FDA has agreed to conduct a pilot program to determine the usefulness of this requirement.

  • The new regulations would have required device company CEOs to submit an annual certification of MDR reports filed, using FDA form 3381. FDA is now proposing a revised version of this requirement.

  • The regulations would have required that each foreign manufacturer designate a U.S. agent to submit MDR reports (and other information) on its behalf. FDA is now seeking industry input on the advisability of this requirement. The result of staying this provision is that foreign manufacturers are now required to submit MDR reports directly to FDA.

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