Some of the terms we use in this part are specific to medical device reporting and reflect the language used in the statute (law). Other terms are more general and reflect our interpretation of the law. This section defines the following terms as used in this part: (a)Ambulatory surgical facility (ASF) means a distinct entity that operates for the primary purpose of furnishing same day outpatient surgical services to patients. An ASF may be either an independent entity (i.e., not a part of a provider
(a)Agency means the Food and Drug Administration. (b)Citation or cite means a document and any attachments thereto that provide notice to a person against whom criminal prosecution is contemplated of the opportunity to present views to the agency regarding an alleged violation. (c)Respondent means a person named in a notice who presents views concerning an alleged violation either in person, by designated representative, or in writing. (d)Responsible individual includes those in positions of power