PDA believes this technical conformance guide has important new content expectations that will have a significant impact on industry, primarily those involved in combination product submissions. As such, PDA strongly believes that these expectations should have been issued in a Type 1 draft policy guidance and not as final. Publication in a final technical conformance guide, will not, and has not resulted in sufficient awareness among concerned parties. Thus, PDA believes FDA will not receive a full range of comments; which undermines the necessary public’s input on these topics. PDA also believes this substantive content is more appropriate for a draft policy guidance and not for publication or inclusion in a technical conformance guide. The confounding of policy and technical issues is a disservice to both industry and the FDA.
PDA strongly encourages FDA to withdraw the sections of the eCTD conformance guide related to Combination Products and Human Factors and re-issue these in a Type 1 draft guidance. In addition, PDA offers the comments to those sections to be considered for the draft guidance.