medical device
Defined in 9 places across 3 titles — 3 distinct definitions of the United States Code.
The term “medical device” has the meaning given the term “device” in section 321 of title 21.
Same definition in 7 sections
- 2026–present22 U.S.C. § 10704Foreign Relations and Intercourse · Sanctions relating to the Western Balkans · in this section
- 2000–present22 U.S.C. § 7201Foreign Relations and Intercourse · Definitions · in this chapter
- 2010–present22 U.S.C. § 8511Foreign Relations and Intercourse · Definitions · in this subchapter
- 2024–present22 U.S.C. § 8572Foreign Relations and Intercourse · Imposition of sanctions with respect to Iranian petroleum · under this section
- 2012–present22 U.S.C. § 8722Foreign Relations and Intercourse · Imposition of sanctions with respect to provision of underwriting services or insurance or reinsurance for the National Iranian Oil Company or the National Iranian Tanker Company · in this section
- 2012–present22 U.S.C. § 8801Foreign Relations and Intercourse · Definitions · in this chapter
- 2017–present22 U.S.C. § 9410Foreign Relations and Intercourse · Exceptions for national security and humanitarian assistance; rule of construction · in this section
The term "medical device" means a device, as defined in section 321(h) of this title, and includes any device component of any combination product as that term is used in section 353(g) of this title.
Source
- 1998–present21 U.S.C. § 1602Food and Drugs · Definitions · as used in this chapter
The term “medical device” means any device (as defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)), diagnostic product, drug (as defined in the Federal Food, Drug, and Cosmetic Act), and drug delivery system—
(A) if such device, product, drug, or drug delivery system utilizes a class I or class II substance for which no safe and effective alternative has been developed, and where necessary, approved by the Commissioner; and
(B) if such device, product, drug, or drug delivery system, has, after notice and opportunity for public comment, been approved and determined to be essential by the Commissioner in consultation with the Administrator.
Source
- 1994–present42 U.S.C. § 7671The Public Health and Welfare · Definitions · as used in this subchapter