FDA is Considering Potential Guidance Documents for Development
The Food and Drug Administration (FDA)'s Center for Devices and Radiological Health (CDRH) has posted a list of guidance documents under consideration for development, including items on infusion pumps and 510(k) modifications.
The list, which covers items that may be published in fiscal year 2012, is the result of negotiations between the FDA and industry over the reauthorization of the Medical Device User Fee and Modernization Act. In exchange for additional funding from industry, the FDA says it agreed to annually post a list of guidance documents CDRH is considering, and allow stakeholders to weigh in.
"CDRH believes this docket is an important tool for receiving information from interested parties and for making information available to the public," the FDA says in a notice about the initiative.
Specific topics that may be covered in new guidance documents include:
- Medical devices that include antimicrobial agents
- Distinguishing and reporting medical device recalls from product enhancements
- Appropriate use of consensus standards in premarket submissions
- Design considerations for pivotal clinical investigations
- Design considerations for devices labeled for home use
The agency cautions that not all of these topics will become guidance documents and that there could be guidance documents that are not currently on the list. "Our experience over the years has shown that there are many reasons CDRH staff does not complete the entire annual agenda of guidances it undertakes," the notice reads. "Staff are frequently diverted from guidance development to other activities, including review of premarket submissions or post market problems."
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