FDA reviewing CDRH risk notifications

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

The FDA is evaluating the “clarity and timeliness” of two publications that the Center for Devices and Radiological Health (CDRH) issues to healthcare practitioners to convey information about potential device risks.

The Public Health Notification (PHN) is published when CDRH has information or a message to convey that practitioners would want to know  to make informed decisions about using a specific device. The preliminary PHN contains similar information, but under different conditions. For example, CDRH’s understanding of the problem, cause and scope of the risk involved in using the device in question is still evolving and is being actively investigated by the center.

The agency said it wants to evaluate the clarity, timeliness and impact of the safety alerts and public health advisories by surveying a sample of recipients. The information collected will address how clearly notifications for reducing risks are explained, the timeliness of the information provided and whether the reader has taken action as a result of the information received. The information will then be used to shape editorial policy for the PHN and preliminary PHN.

The FDA is looking for comments on:

  1. Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
  1. The accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
  1. Ways to enhance the quality, utility and clarity of the information to be collection and
  1. Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of IT.

The comments are due by Oct. 23.