510(k) | 合法醫療器材資訊網

Whatdoes510(k)exemptmean?Whena510(k)submissionisrequireditmeansthattheFDAisrequestingnotification,alongwithevidencethatthemedical ...

In the FDA-regulated medical device world, there are 3 classifications for medical devices: Class I, Class II and Class III. The FDA (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm[1]) provides a rather in-depth overview of how to classify a medical device and the requirements behind each products classification. What may not be evident, or often discussed in common conversation, is that many Class I and some Class II medical devices are 510(k) exempt.

What does 510(k) exempt mean? When a 510(k) submission is required it means that the FDA is requesting notification, along with evidence that the medical device intended to be marketed is safe and effective, prior to a company commercializing its product. In some instances though, the FDA has placed specific medical devices into an "exempt" status. Now, this is not to imply that the FDA does not have ...