FDA GUIDANCE COVERS POSTAPPROVAL STUDY REPORTS FOR DEVICE CLINICAL TRIALS
Device clinical trial sponsors will be subject to new requirements under FDA draft guidance on the format, content and review of reports related to clinical postapproval studies.
Postapproval requirements may include continuing evaluation and periodic reporting on the safety, effectiveness and reliability of a device for its intended use, the Dec. 21 guidance says.
The agency may order postmarket surveillance and potentially withdraw premarket approval if sponsors do not comply with postapproval study requirements, the guidance says. "In addition, a significant or knowing failure to report information about a postapproval study, or where such failure constitutes a risk to public health, may result in FDA initiating a civil money penalties action."
The FDA may tap advisory panels when considering the initiation or progress of postapproval studies for device clinical trials, the guidance says. "To assure the advisory panel is kept current on the progress of the postapproval studies, we may present or may request that you present the status or outcomes of the studies to the advisory panels during their public meetings."
The draft guidance, "Procedures for Handling Post-Approval Studies Imposed by PMA Order," can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/2005d-0348-gdl0002.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/2005d-0348-gdl0002.pdf).