EDITOR'S PAGE
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The IVDMIA draft guidance proposes a significant change in FDA practice. It would involve the agency in regulating some lab-developed tests as medical devices and overseeing the labs that develop such tests as medical device manufacturers. During the February meeting, OIVD officials heard presentations from speakers representing stakeholders involved in the development or use of clinical diagnostics. The speakers offered comments about the draft guidance and how FDA’s proposed regulation of IVDMIAs would affect the groups they represented (see Trends & Perspectives). Overall, speakers at the OIVD meeting suggested that the draft guidance raises important questions about FDA’s regulations, which require further clarification.
However, some of the speakers suggested that the release of the IVDMIA guidance raised even bigger issues, and expressed dismay with the agency’s failure to involve industry earlier in developing this important guidance document.
By not discussing such a significant change with interested parties before its public release, the agency created concern about its overall process for formulating major new guidance documents.
Before introducing policy changes as important as those in the IVDMIA draft guidance, said the speakers, FDA should make sure that all stakeholders are involved in the guidance development process by providing them an opportunity early on to give their input. The stakeholders can offer valuable feedback and insights on how proposed changes will affect public health and the operations of various sectors, such as IVD manufacturers.
With such initial feedback and insight, later misinterpretations and misunderstandings of FDA’s intentions can be avoided. In the IVDMIA draft guidance, for example, the agency did not clearly articulate its objectives. Consequently, what FDA tried to say in the draft guidance is very different from how the stakeholding public understood what the agency was trying to achieve.
FDA’s good guidance practices (GGPs) recognize the importance of public participation in developing draft guidance documents. But according to those guidelines, a public meeting to discuss a draft guidance can be held only after the agency has drafted the document. As IVDs become more complex and play a greater role in healthcare, FDA should revisit its GGP guidelines and revise them to ensure that relevant stakeholders are involved in the IVD guidance development process as early as possible.
