(b) An active diagnostic medical device referred to in sub-clause (1) of clause (a) shall be assigned to Class A, if it is intended to be used solely to illuminate a patient's body with light in the visible or near infrared spectrum. (c) An active diagnostic medical device referred to in clause (a) shall be assigned to Class C, if it is intended specifically for, — (1) the monitoring of vital phys ...

The manufacturer shall establish and maintain a record for each batch of medical device or in vitro diagnostic medical devices that provides traceability and identifies the amount manufactured and amount approved for distribution. The batch record shall be verified and approved. 7.5.1.2 Control of production and service provision—Specific requirements 7.5.1.2.1 Cleanliness of product and contamin ...

POLICY ON POST-APPROVAL STUDIES 1. Post-approval studies may be required to provide additional information on the efficacy, safety, and use of the drug in populations more diverse than included in the clinical trials conducted prior to approval of the new drug in accordance with the provisions of the rules. 2. Necessary guidance documents should o be developed to provide the extent of requirements ...