The FDA is responsible for reviewing foods and products that are marketed to the public.
The U.S. Food and Drug Administration, or FDA, is under the umbrella of the U.S. Department of Health and Human Services. The FDA is responsible for reviewing food, drugs, medical devices, vaccines, cosmetics and other products for safety. Normally, the FDA must review foods and products before they can be legally marketed.
Clearance
The FDA clears drugs, devices or other products after reviewing a pre-market notification form. A pre-market notification, also referred to as a 510(k) form, is filed with the FDA upon the item's creation. The notification simply alerts the FDA about the new product so that it can be reviewed to ensure that it meets federal safety guidelines.
Approval
The FDA approves drugs, devices or other products after reviewing a pre-market approval application that has been submitted. The approval application form differs from the notification form, since it is reserved for foods, drugs, medical devices or products that require more rigorous review.
510(k) Form
Depending on the classification of the drug, device or product, either a 510(k) or pre-market approval application will need to be filed. In short, if the item is substantially equivalent to another item that is already legally marketed for the same use and purpose, then the submitter should submit a 510(k) application form.
Pre-Market Approval Form
If no comparable item exists on the market, then the submitter must submit a pre-market approval application form that provides reasonable evidence that the device is both safe and effective. The approval process, as opposed to the clearance process, is generally reserved for high-risk medical devices or questionable products that have no existing equivalent and, thus, require more scrutiny.
Submission of Application For Clearance or Approval
Normally, both 510(k) and pre-market approval applications are submitted by the manufacturer or producer of a given product. However, this is not always the case. Further, the submitter of the application is responsible for proving either that the item is similar in design and function to a previously authorized item or that the item is safe and effective. The FDA does not research products, but simply reviews the research provided by the manufacturer or submitter.
Tags: approval application, pre-market approval, application form, medical devices, other products
