; and (B) are approved, licensed, or cleared for commercial distribution under section 505, 510(k), or 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 , 360(k), 360(e)) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) and are available to diagnose, monitor, or treat the patient’s disease or condition. (4) A certification that the probable risk to the patient from the experimental drug, biological product, or device is not greater than the probable risk from the patient’s disease or condition. (5) A certification that the physician has provided the patient with a written statement and oral explanation of the medical treatment to be provided using the experimental drug, biological product, or device. (6) An acknowledgement signed by the patient (or the patient’s legal representative) that the physician has provided the written statement and oral explanation required by paragraph (5), and has disclosed the following: (A) That the medical treatment using the experimental drug, biological product, or device is experimental or nonconventional. (B) That the experimental drug, biological product, or device has not been approved, licensed, or cleared for commercial distribution under section 505, 510(k), or 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 , 360(k), 360(e)) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) for any indication. (C) The material risks generally recognized by a reasonably prudent physician of the medical treatment’s side effects. (D) An explanation of the medical treatment, including the expected frequency and duration of the treatment. (c) No liability or use of outcomes (1) No liability Notwithstanding any other provision of law, no liability shall lie against a producer, manufacturer, distributor, prescriber, dispenser, possessor, or user of an experimental drug, biological product, or device for the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product,