What This Means
There is a 60-day comment period for this draft guidance. Comments should be submitted to the FDA Division of Dockets Management. Detailed instructions for submitting comments are available at the beginning of the draft guidance document.
In the meantime, the FDA will not require individual applicants to code the text in the Highlights section of their SPL submissions. As a result, you will not need to implement SNOMED within your SPL submissions.
Your clinical trials and safety data should continue to be coded to MedDRA as before. In other words, the original FDA announcement and the subsequent draft guidance document should have no impact on how your data is currently coded.
The FDA remains committed to MedDRA for adverse event reporting, as evidenced by its plans for AERS II, the FDA's new adverse event reporting system.