Medical device regulation : FDA-CDRH manufacturing, policies and regulation handbook /
This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool he...
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| Format: | eBook |
| Language: | English |
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London, United Kingdom ; San Diego, CA, United States ; Cambridge, MA, United States ; Kidlington, Oxford, United Kingdom :
Elsevier, Academic Press, an Imprint of Elsevier,
[2023]
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| Online Access: | Connect to the full text of this electronic book |
Table of Contents:
- Section 1. How to study and market a medical device. Overview of medical device regulation
- How to market a medical device
- Premarket notification [510(k)]
- Device modifications requiring new 510(k) submission
- Premarket approval (PMA)
- Investigational device exemption
- In vitro diagnostics
- Clinical studies for medical device
- Medical device labeling requirements
- FDA Medical Devices Advisory Committees
- Human factors and medical devices
- Mobile medical applications, software, and wireless coexistence
- Cybersecurity in medical devices
- Section 2. Postmarket activities and FDA collaboration. Postmarket surveillance and requirements
- Compliance and enforcement
- The quality system regulation
- Risk management
- Meeting and collaboration with the FDA
- Future of the medical device industry.