Tips for commenting on FDA Guidance Documents

The FDA Center for Devices and Radiological Health (CDRH), which is also responsible for medical devices, has published tips on how to comment on guidance issued by the Center on a new website.

The CDRH considers comments on their guidelines to be very helpful for their improvement and incorporates the comments where appropriate. Tips for commenting are provided on almost three pages.

The CDRH recommends keeping an eye on the comment period for draft guidelines to be able to comply with it. Actually, comments on a guideline can be submitted at any time (21 CFR 10.115). However, these can then only be taken into account in the next revision of the corresponding guideline. Now for the tips:

  • Comments can be submitted electronically or in writing 
  • Comments should be brief and concise, although revised text or additional text, if useful, is also welcome 
  • Comments should reference individual sections, reference to line numbering is preferred 
  • Comments should include explanations so that the CDRH understands what is meant by the comment. 
  • Repetition of the same comments should be avoided (if repetition would be necessary, comment once and then indicate that the comment also applies to section X or lines 1, 2, 3, etc.) 
  • The comments should be made in tabular form if possible (an example is included in the FDA description)

The following further explains which portal can be used to submit comments electronically and how written comments can be submitted. The FDA explicitly mentions that the comments will be published. If one does not want this, a submission is not possible electronically and the comments and, if applicable, supplementary documents must be marked as "confidential". The same applies if the name or contact details are not to be published. Submissions must have a reference to the docket number. These docket numbers are listed on a CDRH Guidelines website. Comments that are not confidential are published under this docket number.

You can find the tips for commenting on CDRH guidelines on the new CDRH website.

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