Author(s):
Janarthanan. S, RajuKamaraj
Email(s):
sjanarthanan3624@gmail.com
DOI:
10.5958/0974-360X.2020.00786.6
Address:
Janarthanan. S, RajuKamaraj
Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur – 603203, Kanchipuram, Tamil Nadu, India.
*Corresponding Author
Published In:
Volume - 13,
Issue - 9,
Year - 2020
ABSTRACT:
The United States is the main therapeutic gadget showcase on the planet, representing over 40% of all social insurance spending around the world. The regulation of medical device varies from country to country. The medical device approval in U.S is examined closely by its regulatory body which is discussed. It consists of different stages for safe and efficient regulatory strategy. This article mainly focuses on elaborate study on marketing approval of medical device in U.S. FDA (Food and Drug Administration) is the regulatory body which is accountable for assessing and regulating the safety and quality of medical device and other health products in U.S.
Cite this article:
Janarthanan. S, RajuKamaraj. Medical Device regulation in U.S. Research J. Pharm. and Tech 2020; 13(9):4453-4456. doi: 10.5958/0974-360X.2020.00786.6
Cite(Electronic):
Janarthanan. S, RajuKamaraj. Medical Device regulation in U.S. Research J. Pharm. and Tech 2020; 13(9):4453-4456. doi: 10.5958/0974-360X.2020.00786.6 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2020-13-9-74
REFERENCE:
1. Medical device regulation available from: https://www.fda.gov/medical-devices accessed on June 10,2019
2. A Comprehensive Analysis of the FDA 510(k) Process: http://www.510k.net/ accessed on June 10, 2019
3. 510(K) Premarket Submission from http://anvpublication.org/HTMLPaper.aspx?Journal=Research%20Journal%20of%20Pharmacy%20and%20Technology; PID=2018-11-12-77 accessed on June 12, 2019
4. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearannces/ accessed on June 20, 2019
5. http://www.rotlaw.com/legal-library/what-is-the-fdas-510k-approval-process/
6. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm#top
7. D. Bhavyasri, K. Manikandan, R. Kamaraj. Marketing Approval for Medical Devices in European Union. Research J. Pharm. and Tech 2019; 12(1): 391-395.
8. http://health.economictimes.indiatimes.com/news/medical-devices/india-the-new-destination-for-healthcare-equipment-industry/46847343
9. http://ficci.in/sector/76/Project_docs/Medical_Devices_and_Equipment_Sector_profile.pdf
10. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm
11. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134034.htm
12. https://oig.hhs.gov/oei/reports/oei-04-10-00480.pdf