ABSTRACT
The actual 510(k) submission will vary in complexity and length according to the type of device or product change for which substantial equivalency is sought. A 510(k) should be accompanied by a brief cover letter that clearly identifies the submission as a 510(k) premarket notification. To facilitate prompt routing of the submission to the correct reviewing division within Food and Drug Administration (FDA), the letter can mention the generic category of the product and its intended use. An Institutional Review Board (IRB) has the authority to review and approve, require modification, or disapprove an investigation. If no IRB exists or if FDA finds an IRB’s review to be inadequate, a sponsor may submit an application directly to FDA. Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device.
