FDAnews Device Daily Bulletin

Companies could get a better idea of what the FDA expects in postapproval studies (PAS) required as part of a device’s approval at an Aug. 30 agency workshop. The meeting is intended to encourage the design of PAS that simultaneously meet the needs of regulatory bodies, manufacturers and other affected groups. According to a Tuesday Federal Register notice, data generated by PAS are most useful if they are specific, detailed and can be leveraged for use by multiple stakeholders. Topics slated for discussion include the role of PAS in the total product life cycle, best practices and PAS implementation strategies, PAS impact on public health and device innovation and opportunities for innovative use of PAS data.
Devices & Diagnostics Letter