; (2) life-sustaining; (3) life-supporting; or (4) used significantly in pediatric populations. (d) Rule of construction Nothing in this section shall be construed to require device user facilities or health professionals to provide patient information to the manufacturer or importer of the device. . 3. Prohibited acts Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: (jjj) The refusal or failure to submit notifications in accordance with paragraphs (1) and (2) of section 518B(b). (kkk) The refusal or failure to provide notice in accordance with section 518C. .