| 1 | 1 | | I |
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| 2 | 2 | | 119THCONGRESS |
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| 3 | 3 | | 1 |
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| 4 | 4 | | STSESSION H. R. 1539 |
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| 5 | 5 | | To amend the Federal Food, Drug, and Cosmetic Act to expand the types |
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| 6 | 6 | | of devices for which required labeling may be made available solely |
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| 7 | 7 | | by electronic means, and for other purposes. |
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| 8 | 8 | | IN THE HOUSE OF REPRESENTATIVES |
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| 9 | 9 | | FEBRUARY24, 2025 |
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| 10 | 10 | | Mr. O |
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| 11 | 11 | | BERNOLTE(for himself, Mr. MULLIN, Mr. CRENSHAW, and Ms. CRAIG) |
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| 12 | 12 | | introduced the following bill; which was referred to the Committee on En- |
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| 13 | 13 | | ergy and Commerce |
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| 14 | 14 | | A BILL |
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| 15 | 15 | | To amend the Federal Food, Drug, and Cosmetic Act to |
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| 16 | 16 | | expand the types of devices for which required labeling |
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| 17 | 17 | | may be made available solely by electronic means, and |
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| 18 | 18 | | for other purposes. |
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| 19 | 19 | | Be it enacted by the Senate and House of Representa-1 |
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| 20 | 20 | | tives of the United States of America in Congress assembled, 2 |
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| 21 | 21 | | SECTION 1. SHORT TITLE. 3 |
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| 22 | 22 | | This Act may be cited as the ‘‘Medical Device Elec-4 |
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| 23 | 23 | | tronic Labeling Act’’. 5 |
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| 24 | 24 | | VerDate Sep 11 2014 03:45 Mar 13, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1539.IH H1539 |
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| 25 | 25 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 2 |
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| 26 | 26 | | •HR 1539 IH |
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| 27 | 27 | | SEC. 2. ALLOWING REQUIRED LABELING OF DEVICES TO 1 |
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| 28 | 28 | | BE MADE AVAILABLE SOLELY BY ELEC-2 |
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| 29 | 29 | | TRONIC MEANS. 3 |
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| 30 | 30 | | Section 502(f) of the Federal Food, Drug, and Cos-4 |
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| 31 | 31 | | metic Act (21 U.S.C. 352(f)) is amended to read as fol-5 |
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| 32 | 32 | | lows: 6 |
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| 33 | 33 | | ‘‘(f)(1) Unless its labeling bears (A) adequate direc-7 |
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| 34 | 34 | | tions for use; and (B) such adequate warnings against use 8 |
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| 35 | 35 | | in those pathological conditions or by children where its 9 |
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| 36 | 36 | | use may be dangerous to health, or against unsafe dosage 10 |
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| 37 | 37 | | or methods or duration of administration or application, 11 |
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| 38 | 38 | | in such manner and form, as are necessary for the protec-12 |
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| 39 | 39 | | tion of users, except that where any requirement of clause 13 |
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| 40 | 40 | | (A) of this subparagraph, as applied to any drug or device, 14 |
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| 41 | 41 | | is not necessary for the protection of the public health, 15 |
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| 42 | 42 | | the Secretary shall promulgate regulations exempting such 16 |
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| 43 | 43 | | drug or device from such requirement. 17 |
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| 44 | 44 | | ‘‘(2) Subject to subparagraph (3), required labeling 18 |
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| 45 | 45 | | for devices (including in vitro diagnostic devices) may be 19 |
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| 46 | 46 | | made available solely by electronic means, provided that— 20 |
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| 47 | 47 | | ‘‘(A) such required labeling is readily accessible 21 |
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| 48 | 48 | | to intended users of such devices; 22 |
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| 49 | 49 | | ‘‘(B) the manufacturer affords intended users 23 |
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| 50 | 50 | | of such devices the opportunity to request the re-24 |
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| 51 | 51 | | quired labeling in paper form, and upon such re-25 |
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| 52 | 52 | | VerDate Sep 11 2014 03:45 Mar 13, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1539.IH H1539 |
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| 53 | 53 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 3 |
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| 54 | 54 | | •HR 1539 IH |
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| 55 | 55 | | quest, promptly provides the requested information 1 |
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| 56 | 56 | | in paper form without additional cost; and 2 |
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| 57 | 57 | | ‘‘(C) the label affixed to the device or its imme-3 |
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| 58 | 58 | | diate container includes all information in compli-4 |
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| 59 | 59 | | ance with this Act and the regulations thereunder or 5 |
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| 60 | 60 | | any applicable order of the Secretary under subpara-6 |
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| 61 | 61 | | graph (3)(A). 7 |
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| 62 | 62 | | ‘‘(3)(A) With respect to devices for which labeling is 8 |
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| 63 | 63 | | made available solely by electronic means, the Secretary 9 |
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| 64 | 64 | | may issue an order establishing requirements in addition 10 |
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| 65 | 65 | | to, or exceptions from, the requirements under subpara-11 |
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| 66 | 66 | | graph (2) for the label affixed to a device type. 12 |
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| 67 | 67 | | ‘‘(B) Notwithstanding subchapter II of chapter 5 of 13 |
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| 68 | 68 | | title 5, United States Code, such order shall be published 14 |
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| 69 | 69 | | in the Federal Register, following publication of a pro-15 |
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| 70 | 70 | | posed order in the Federal Register and consideration of 16 |
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| 71 | 71 | | comments to a public docket. 17 |
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| 72 | 72 | | ‘‘(C) Such order may require the label of a device 18 |
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| 73 | 73 | | to contain certain information or comply with certain con-19 |
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| 74 | 74 | | ditions only if the Secretary determines such requirement 20 |
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| 75 | 75 | | is necessary to provide a reasonable assurance of the safe-21 |
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| 76 | 76 | | ty and effectiveness of the device.’’. 22 |
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| 77 | 77 | | Æ |
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| 78 | 78 | | VerDate Sep 11 2014 03:45 Mar 13, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\H1539.IH H1539 |
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| 79 | 79 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB |
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