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puneet replied to the topic Delay in Recall. in the forum Regulatory Basics for Medical Devices 7 years, 8 months ago
The one reason for a device to be recalled by the FDA is if there are any unforeseen issues that arrive after the product has been approved to be put on the market. In most cases, I believe the companies discover defects or issues themselves and contact the FDA. The only way I could see to improve this process would be more quality control and more controlled trials before gaining approval to eliminate as many issues as possible and test for as many potential problems as possible, though I think it is unlikely to ever completely eliminate all defects even with improved quality assurance as not all unforeseen issues can be caught or predicted beforehand.