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Medical device reporting and recalls have enormous benefits for the medical device company and the public if implemented properly. They can prevent use of defective devices and can be an important inoculation against stringent FDA actions.
Medical device reporting and recalls are a major FDA activity. Medical device companies have clear instructions on how to initiate medical device reporting (MDR) and recalls.
Procedures for medical device reporting are governed by 21 CFR 803, which has details regarding how a medical device company should go about its MDR.
The FDA deems it mandatory for these entities to report certain types of adverse events and product problems:
For the following entities, MDR is voluntary and is to be done when serious adverse events are detected in the medical devices they use:
These categories can also report issues relating to product quality, therapeutic errors and use errors.
A recall is important for two reasons:
Firms have to follow 21 CFR Part 806 when they have to reporting Medical Devices Recalls, as set out by The Center for Devices and Radiological Health. The Center makes it a requirement for a firm to report when the medical device is posing a risk to health. This has to be reported to the FDA District Office in which the firm is located.
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