TECHNICAL UPDATES TO CLINICAL TRIALS DATABASE.

SEC. 2051. TECHNICAL UPDATES TO CLINICAL TRIALS DATABASE. Section 402(j)(2)(D) of the Public Health Service Act (42 U.S.C. 282(j)(2)(D)) is amended— (1) in clause (ii)(I), by inserting before the semicolon “, unless the responsible party affirmatively requests that the Director of the National Institutes of Health publicly post such clinical trial information for an applicable device clinical trial prior to such date of clearance or approval”; and (2) by adding at the end the following: “(iii) Option to make certain clinical trial information available earlier.—The Director of the National Institutes of Health shall inform responsible parties of the option to request that clinical trial information for an applicable device clinical trial be publicly posted prior to the date of clearance or approval, in accordance with clause (ii)(I). “(iv) Combination products.—An applicable clinical trial for a product that is a combination of drug, device, or biological product shall be considered— “(I) an applicable drug clinical trial, if the Secretary determines under section 503(g) of the Federal Food, Drug, and Cosmetic Act that the primary mode of action of such product is that of a drug or biological product; or “(II) an applicable device clinical trial, if the Secretary determines under such section that the primary mode of action of such product is that of a device.” .