- Häftad (Paperback / softback)
- Antal sidor
- National Academies Press
- Wizemann, Theresa (red.)
- col. Illustrations
- 222 x 146 x 6 mm
- 294 g
Du kanske gillar
Public Health Effectiveness of the FDA 510(k) Clearance Process
Measuring Postmarket Performance and Other Select Topics: Workshop Reportav Institute Of Medicine, Board On Population Health And Public Health Practice, Committee On The Public Health Effectiveness Of The Fda 510 Clearance Process, Theresa Wizemann419
The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.
- Skickas inom 7-10 vardagar.
- Gratis frakt inom Sverige över 159 kr för privatpersoner.
Passar bra ihop
De som köpt den här boken har ofta också köpt Informatics Needs and Challenges in Cancer Rese... av Institute Of Medicine, Board On Health Care Services, National Cancer Policy Forum, Theresa Wizemann, Sharyl J Nass (häftad).Köp båda 2 för 808 kr
KundrecensionerHar du läst boken? Sätt ditt betyg »
Fler böcker av författarna
Institute Of Medicine, National Research Council, Division Of Behavioral And Social Sciences And Education, Youth Board On Children And Families, Youth And Young Committee On The Prevention Of Mental Disorders And Substance Abuse Among Children
Division Of Behavioral And Social Sciences And Education, Institute Of Medicine, Youth Board On Children And Families, Committee On Integrating The Science Of Early Childhood Development, Deborah A Phillips
1 Front Matter; 2 1 Introduction; 3 2 Food and Drug Administration Postmarket Surveillance Activities and Recall Studies of Medical Devices; 4 3 Non-Food and Drug Administration Sources of Adverse Event Data; 5 4 Postmarket Surveillance of Medical Devices: Panel Discussion; 6 5 Other Select Topics; 7 Appendix A: Workshop Agenda; 8 Appendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers; 9 Appendix C: 510(k) Premarket Notification Analysis of FDA Recall Data; 10 Appendix D: Trustworthy Medical Device Software