Medical Device User Fee and Modernization Act of 2002: supplemental report (to accompany H.R. 3580).
U.S. Government Printing Office, 2002 - Medical instruments and apparatus industry
What people are saying - Write a review
We haven't found any reviews in the usual places.
Other editions - View all
$1 million 13 Estimated outlays 38 48 Estimated accredited advance in appropriation appropriation acts appropriations for FDA’s approval to market authority to assess bill would require breast implants CBO assumes FDA CBO estimates class IH devices combination products Cosmetic Act current law device applications Drug Estimated authorization level estimates that implementing exempt from ﬁling facturers of medical FDA’s authority Federal Food ﬁrms that reprocess ical identiﬁes included in CBO’s istration less than $1 mandates as deﬁned manufacturers of medical ments million in 2003 million in additional necessary amounts necessary between 2003 number of requirements oﬁce paper forms premarket notiﬁcation submission premarket reports private-sector mandates provided in advance provisions would cost Radiologic Health registrations electronically regulation of medical reprocess single-use devices require FDA require manufacturers required to submit submit validation data substantially equivalent third-party inspection program third-party review tion Title H tribal governments UMRA $115 million user fee program workload