Zdrowie i gospodarka · 19/04/2000

Guidance Documents for Premarket Notification (510(k)) Submissions for Six Devices; Availability

The Food and Drug Administration (FDA) is announcing the availability of six guidance documents. These six guidance documents are intended to serve as special controls for six devices that FDA has proposed previously to reclassify from class III (premarket approval) to class II (special controls). Elsewhere in this issue of the Federal Register, FDA is reopening the comment period on the proposed reclassification of the six devices and one other device. FDA is now inviting comment on these guidance documents because they were not available for comment at the time of the publication of the proposed reclassification (64 FR 12774, March 15, 1999).