December 19
Submission of the Premarket Notification
The submission of a Premarket Notification is an important thing. The provisions of section 510(k) of the Food, Drug and Cosmetics Act require the submission of the said notification. The submission of the said notification must be made ninety (90) days prior to the planned introduction and presentation of medical devices. The Food and Drug Administration upon the notification of the company shall evaluate and classify the medical devices. The medical devices are classified into three categories which presents different level of risks. Category one has the least regulatory control. On the other hand, category two is under the general controls and special controls of the Food and Drug Administration. Category three is the most stringent among the three. Medical device belonging to this category are those device that has no or has limited information available in the market. Thus, if the medical device is classified into category three, a Premarket Approval from the Food and Drug Administration is needed.
