Classification and Criteria for Amendments to a PMTA - Major and Minor Designations

April 24, 2024

Building a PMTA program requires long-term strategic content plan development that incorporates the prospect of additional submissions to FDA CTP beyond the initial PMTA. Deficiency Letter responses are considered solicited amendments and are straight-forward in their approach and structure. For ongoing product evaluations like stability studies and updates to marketing and labeling material, a criteria has been established to classify this data.

Determining a major or minor amendment to a PMTA is based on the memo released on June 11, 2019 by FDA Center for Tobacco Products titled Classification and Criteria for Determining Major/Minor Amendments for the PMTA Program and updated with 2020's Update to Premarket Tobacco Product Application (PMTA) Review Process: Deficiency Letters and Major Amendments which was signed in 2020.

Major Amendment:

Information that would necessitate substantial FDA review and assessment to integrate the newly submitted information or data into the FDA review and decision process (whether such information is unsolicited or submitted in response to a deficiency letter).  A new 180-day review period would typically begin on the date FDA received the amendment.  Types of information that may necessitate this type of review include:

• Substantial new data from a previously unreported study

• Substantially updated data from a previously reported study,

• Detailed new analyses of previously submitted data,

• Substantial information previously omitted that is material to an authorization decision

• Substantial new manufacturing information (e.g., addition of a new manufacturing site for primary and secondary processes that would prevent FDA from completing its review of the PMTA in a timely manner)

Minor Amendment:

This would include information that would not necessitate reanalysis or additional review of previously submitted data and information to integrate the newly submitted information or data into the FDA discipline review and decision process.   A new 180-day review period would typically not be triggered with a minor amendment. Types of information that could be considered minor include:

• Clarifying information in previous submission

• Certificates of analysis

• New labeling or marketing materials

• Stability testing updates

• Study report of a recently completed study that is not material to the authorization decision

• Administrative amendment (e.g., change in POC, communications about arranging site inspections, other ‘non-substantive’ communications)

Also, an FDA form 4057a Premarket Tobacco Product Application Amendment and General Correspondence Submission is to accompany an amendment.