Earlier U.S. FDA-Devicemaker Talks Could Ease 522 Postmarket Study Process

The U.S. Food and Drug Administration (FDA) will consider adding a mandatory pre-522 discussion period before issuing postmarket surveillance orders, officials at a March 7 FDA public workshop on the process said. The early meeting could spell relief for devicemakers, which have complained the 522 process for gaining approval of postmarket study plans is too rushed.
International Medical Device Regulatory Monitor