The following text field will produce suggestions that follow it as you type.

Loading Inventory...

Indigo

Medical Device Regulation by U U S Government Accountability Office (G, Paperback | Indigo Chapters

From U U S Government Accountability Office (G

Current price: $20.99
Medical Device Regulation by U U S Government Accountability Office (G, Paperback | Indigo Chapters
Medical Device Regulation by U U S Government Accountability Office (G, Paperback | Indigo Chapters

Indigo

Medical Device Regulation by U U S Government Accountability Office (G, Paperback | Indigo Chapters

From U U S Government Accountability Office (G

Current price: $20.99
Loading Inventory...

Size: 0.12 x 9.69 x 0.26

Buy OnlineGet it at Indigo
*Product information may vary - to confirm product availability, pricing, shipping and return information please contact Indigo
Pursuant to a congressional request, GAO compared the Food and Drug Administration's (FDA) and the European Union's (EU) systems for reviewing and approving medical devices, focusing on: (1) key differences between the two systems; (2) the outputs of the two systems; and (3) the feasibility of FDA adopting features of the EU system. GAO found that: (1) U. S. and EU medical device regulatory systems share the goal of protecting public health, but the EU system is designed to facilitate EU-wide trade; (2) while EU reviews medical devices for safety and performance, FDA reviews devices for safety, effectiveness, and benefit to patients; (3) while EU gives major medical device regulatory responsibilities to public agencies and private organizations, FDA has sole responsibility over device regulation in the United States; (4) both systems link the level of medical review to device risk, but the two systems use different procedures to reach approval or clearance decisions; (5) questions and concerns have arisen regarding possible conflicts-of-interest in the EU medical device review process because EU notified bodies carry out a regulatory function within the EU medical device system and conflict-of-interest rules for EU reviewers are less comprehensive than in the United States; (6) sufficient data does not exist on the EU medical device review system to permit meaningful comparison with FDA because the EU system is new and not yet fully operational; and (7) it is too early to evaluate the impact of new FDA streamlined review procedures. | Medical Device Regulation by U U S Government Accountability Office (G, Paperback | Indigo Chapters

More About Indigo at St. Vital Centre

Canada's Largest Bookstore. Indigo is the largest book, gift and specialty toy retailer in Canada

Powered by Adeptmind