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Code · BILL · 114th Congress · H.R. 6 (Reported in House) — To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. · Sec. 2243

Sec. 2243. Exclusion from definition of device

65 words·~1 min read·/bill/114/hr/6/rh/section-2243

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Section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ) is amended— in subparagraph (2), by striking or after or other animals, ; in subparagraph (3), by striking and and inserting or ; and by inserting after subparagraph
(3)the following: not health software (other than software determined to be a risk to patient safety under section 524B(b)), and .
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Sec. 2243
Exclusion from definition of device
U.S.C.§ 321
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