FDA announces updated guidance for devices labeled as sterile

The FDA recently announced the issuance of a guidance document to update and clarify information regarding the sterilization process that sponsors should include in the 510(k) submission for devices labeled as sterile.

Steven Turtil, MS, an FDA representative, held a recent webinar to update manufacturers on the recommendation for the 510(k) submission of products labeled as “sterile” to undergo industrial terminal sterilization processes based on microbial inactivation. The guidance updates a 2008 FDA document and now includes examples of “novel sterilization methods.”

“These are newly developed methods for which there is little or no published information, no history of comprehensive FDA evaluation of sterilization development or validation data through an FDA clearance or PMA approval for the devices subjected to these sterilization methods, and no FDA recognized dedicated consensus standards on development, validation or routine control,” Turtil said.

The guidance document was issued on Jan. 21, but a 60-day delayed implementation period has been announced for the changes, Turtil said in the webinar. This will enable companies to prepare prospective submissions, will allow for the completion of 510(k) submissions currently under review, and will allow for additional training of FDA review staff on the updated recommendations and review procedures. The recommendations for the devices will go into effect on March 21.

According to the guidance document, the recommendations for the devices were needed as the FDA has received an increasing number of devices being sterilized under the “novel sterilization methods,” rather than the “established categories,” such as dry heat, steam and radiation.

Examples of “novel sterilization” include the use of sound waves, ultraviolet light, microwave radiation and other methods, Turtil noted.

The underlined theme of the recommendations, Turtil said, is for the FDA to receive a high degree of assurance to make sure each method of sterilization has been adequately validated.

“We are looking at conformity to standards, or based on information we have already received, we want to know that the validation has been performed adequately. In the instance of novel sterilization methods, we are going to be looking for the validation data for the first time,” he said in the webinar.

If a device is sterilized through one of the “novel” methods, the FDA recommends manufacturers include a comprehensive description of the sterilization process, the method used to validate the sterilization cycle and the validation protocol. In addition, the FDA also recommends the manufacturer include any sterilization validation data and should identify any applicable published scientific literature.

The FDA may request additional information based on the specific device submitted for review if it was sterilized using one of the novel methods, Turtil said. – by Robert Linnehan

Reference: