Section 1 Discontinuance or interruption in the production of life-saving devices
Notification requirement— Section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) is amended—
in the section heading, by striking “life-saving drugs” and inserting “life-saving drugs and devices”;
in the matter preceding paragraph (1) in subsection (a), by striking “a drug” and inserting “a drug or device”;
in subsection (a)(1)(C), by striking “such drug” and inserting “such drug or device”;
in the matter following paragraph (2) in subsection (a), by striking “the drug” each place it appears and inserting “the drug or device”;
in subsection (c), by striking “the drugs” and inserting “the drugs or devices”;
in the matter before paragraph (1) in subsection (g), by striking “a drug shortage of a drug described in subsection (a)” and inserting “a drug or device shortage of a drug or device described in subsection (a)”;
in subsection (g)(1), by striking “or a supplement to such an application submitted under section 505(j), that could help mitigate or prevent such shortage” and inserting “a supplement to such an application submitted under section 505(j), or a submission for clearance of a device under section 510(k), classification of a device under section 513(f)(2), or approval of a device under section 515, that could help mitigate or prevent such shortage”;
in subsection (g)(2), by striking “such drug shortage” and inserting “such drug or device shortage”;
in subsection (h), by amending paragraph (2) to read as follows:
“(2) the term drug or device shortage or shortage, with respect to a drug or device, means a period of time when the demand or projected demand for the drug or device within the United States exceeds the supply of the drug or device; and”
in subsection (h)(3)(A), by striking “a drug” and inserting “a drug or device”.
Annual reporting on shortages— Section 506C–1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c–1) is amended—
in the section heading, by striking “drug shortages” and inserting “drug and device shortages”;
in subsections (a) and (b), by striking “drug shortages” each place it appears and inserting “drug and device shortages”;
in subsection (a)(2), by striking “the staff of the Center for Drug Evaluation and Research's Office of Compliance and Drug Shortage Program” and inserting “the staffs of the Center for Drug Evaluation and Research's Office of Compliance and Drug Shortage Program and the Center for Devices and Radiological Health”;
in subsection (a)(3)(B)(i), by striking “applications and supplements” and inserting “applications, supplements, and submissions”; and
in subsections (a)(5) and (c), by striking “drug shortage” and inserting “drug or device shortage”.