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Review of new medical devices approvals by USFDA during the period of 2010 to 2014

  • Medical devices are health care products distinguished from drugs for regulatory purposes in most countries based on mechanism of action. Unlike drugs, medical devices operate via physical or mechanical means and are not dependent on metabolism to accomplish their primary intended effect. Developing new medical devices requires clinical investigations and approval process goes through similar process like drugs. Medical device approvals in the period of 2010 to 2014 were searched from USFDA website. Disease burden data in the similar period was searched from centers for disease control and prevention website. Collected data was analyzed to know number of approved devices, top therapy areas, and mechanism of action of these devices. Out of a total of 200 medical devices approvals in the time period of 2010 to 2014, maximum number of devices (51; 25.5%) were approved in the year 2011, cardiovascular (78; 39%) was the top therapy area. Highest number (180; 90%) of approved medical devices belonged to the category III and maximum number (73; 36.5%) of approved medical devices had ―mechanical‖ mechanism of action. The top 3 causes of deaths in USA during 2010 to 2014 were heart disease, cancer and followed by respiratory infection. There was a match between the top diseases and the medical device approvals for top 2 diseases in USA i.e. heart disease, and cancer. With respect to respiratory infections and ailments which was the 3rd leading cause of death only one device was approved out of 200 approvals in total.

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Author:Rewati Limaye, Gerhard FortwengelORCiDGND
DOI original:https://doi.org/10.18203/2349-3259.ijct20182084
Parent Title (English):International Journal of Clinical Trials
Document Type:Article
Year of Completion:2018
Publishing Institution:Hochschule Hannover
Release Date:2019/05/29
Tag:Approvals; Disease burden; Medical devices; USA; USFDA
GND Keyword:Heil- und Hilfsmittel; Genehmigung
First Page:116
Last Page:120
Link to catalogue:1692612263
Institutes:Fakultät III - Medien, Information und Design
DDC classes:610 Medizin, Gesundheit
Licence (German):License LogoCreative Commons - CC BY-NC - Namensnennung - Nicht kommerziell 4.0 International