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FDA Regulatory

Regulatory Issues from the FDA

Articles about FDA Regulatory issues, to help guide clients in the proper direction.

Unique Device Identification: Direct Marking of Devices – Draft Guidance

FDA released this draft guidance to provide its current thinking on direct marking of devices in regards to UDI requirements.  For devices that are intended to be used more than once and reprocessed before each use, they must bear a UDI on the device itself if it is also are required to have a UDI on their labeling.

The guidance is open to comment till September 24, 2015.  Submit electronic comments on the draft guidance to regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

A copy of the draft guidance document. 

FDA outlines how they will review and Analyze adverse reports

The FDA is trying to let the industry know how they are reviewing and following up on adverse event reports (MDR).

  • FDA reviews and analyzes the adverse event report, which results in (one or more of) these actions:
  • Focused monitoring of adverse events by FDA for trends
  • Request from FDA to submitter of report for additional details about the adverse event
  • Device recall by device manufacturer
  • Change in device design by device manufacturer
  • Change in device labeling (e.g,. changes in instructions) by device manufacturer)
  • Decision by device manufacturer to stop selling device
  • Issuance of Public Health Notification (PHN) by FDA to healthcare providers; PHNs usually describe a risk associated with device use and provide
  • recommendations on reducing risk
  • Issuance of safety-related communication by FDA intended for patients or consumers
  • FDA inspection of device manufacturer
  • Testing of device by FDA scientists
  • Change in FDA’s future regulatory decisions (test methods/ requirements, design, labeling)

Companies should realize the possible effect of making an MDR report to the FDA. Company’s investigations and corrective actions are critical to be able to deal with possible FDA follow up on your adverse event report. Having multiple reports on the same device could result in an FDA investigation. You have to make sure that your corrective action which may involve devices in the field have to be reported to the FDA “recall” coordinator and be controlled like a recall.

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