FDA Seeks Feedback on Device Labeling Requirements

The US Food and Drug Administration (FDA) has requested public comment from health care providers until January 3, 2012 on its proposed requirements for medical device labeling to determine whether the agency’s approach is effective and easy to follow.

The regulator is specifically seeking feedback on four points:

  1. Whether proposed label information requirements are necessary for the FDA to perform properly and are useful
  2. How accurate the agency’s estimates are regarding how burdensome the requirements are to industry
  3. How to improve the quality, usefulness and clarity of labeling information
  4. How to minimize burdens of information collection for respondents via automated collection methods


Through such feedback, the FDA intends to assess the user-friendliness of medical device labeling data according to health care providers. The agency plans to use comments to help form its approach to standardizing medical device labeling requirements for medical device manufacturers in the US.

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