The Food and Drug Administration must create a new approach to guidance beyond the current “comprehensive guidance document that covers and entire field or regulatory topic,” according to the Clinical Decision Support Coalition.
The coalition, in a petition sent last week to the FDA, calls this new type of public guidance “case study guidance.” It’s much like the FDA’s old advisory opinions, “in the sense that it is responsive to an industry-raised topic of general concern, based on a specific set of facts, but it is developed by FDA through the guidance development process.”
The CDS Coalition’s request for this new guidance type stems from an effort it undertook to get the agency to provide guidance on specific questions based on three case studies. The case studies surround issues that the healthcare and pharmaceutical industries face when it comes to creating CDS tools. They “involved products that show great promised in the future of pharmaceutical care, with each designed to address a critical clinical need,” according to the petition.
The collation previously made a presentation to the FDA on the use cases. The agency, however, said it could not “share its thinking” on the case studies because that would violate its guidance practices, Brad Thompson, Epstein Becker Green health attorney and coalition member, writes in an email to FierceHealthIT.
The FDA’s lack of policy on clinical decision support is leading to confusion and delays for developers, according to a white paper the CDS Coalition released in February.
"Prompt legislative and/or regulatory action is needed to clarify the scope of CDS software that will be subject to FDA regulation, as well as the specific regulatory requirements that will apply to any software that is regulated," the collation said in the paper.
“All we are requesting is what the agency did for decades: issue public advisory opinions. We are simply proposing that the agency do so through the established guidance development procedures,” the coalition added in its petition.
To learn more:
- here's the petition