Sentences with phrase «adverse health defects»

Not exact matches

Thus, in the final rule, we allow covered entities to disclose protected health information to entities subject to FDA jurisdiction for the following activities: To report adverse events (or similar reports with Start Printed Page 82670respect to food or dietary supplements), product defects or problems (including problems with the use or labeling of a product), or biological product deviations, if the disclosure is made to the person required or directed to report such information to the FDA; to track products if the disclosure is made to a person required or directed by the FDA to track the product; to enable product recalls, repairs, or replacement (including locating and notifying individuals who have received products of product recalls, withdrawals, or other problems); or to conduct post-marketing surveillance to comply with requirements or at the direction of the FDA.

We allow covered entities to disclose protected health information to a person subject to the FDA's jurisdiction, for the following activities: to report adverse events (or similar reports with respect to food or dietary supplements), product defects or problems, or biological product deviations, if the disclosure is made to the person required or directed to report such information to the FDA; to track products if the disclosure is made to a person required or directed by the FDA to track the product; to enable product recalls, repairs, or replacement, including locating and notifying individuals who have received products regarding product recalls, withdrawals, or other problems; or to conduct post-marketing surveillance to comply with requirements or at the direction of the FDA.