ABSTRACT

A recall is a mechanism for the elimination or modification of items that violate the laws of the Food and Drug Administration (FDA). The FDA medical device recalls database was used to identify recalls of medical devices. Maximum devices are worldwide distribution and some are US national wide distribution at the time of recall. Recall is voluntary action. 49 medical devices recalls in 2019 compared to previous years because medical devices reliant on software or computer technology especially in July 8 recall and in September only one recall are occurred it is the highest and least number of recalls in 2019 respectively. 2 recall in January, March, October and 3 recalls in April and June. Number of medical devices recall based on their recall reason. Market numbers of medical devices are increasing that rely on computer technology it is trigger problems. If a company fails to recall any device or product associated with serious health problems or death. Keywords: Food and Drug Administration, Medical devices, code of federal regulations, Federal Food, Drug, and Cosmetic Act
Publication date: 01/10/2021

https://ijbpas.com/pdf/2021/October/MS_IJBPAS_2021_5667.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.10.5667