21 USC 360l
21 U.S. Code § 360l - Postmarket surveillance - Law.Cornell.Edu
Each manufacturer required to conduct a surveillance of a device shall, within 30 days of receiving an order from the Secretary prescribing that the ...
Page 385 TITLE 21—FOOD AND DRUGS § 360l - GovInfo
101–509, set out in a note under section 5376 of Title 5. §360k. State and local requirements respecting devices. (a) General rule. Except as provided in ...
21 U.S.C. § 360l - U.S. Code Title 21. Food and Drugs § 360l
Each manufacturer required to conduct a surveillance of a device shall, within 30 days of receiving an order from the Secretary prescribing that the ...
21 U.S.C. 360l - Postmarket surveillance - Content Details - GovInfo
Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES Part A - Drugs and Devices Sec. 360l ...
21 USC 360l - Postmarket surveillance - CustomsMobile
The Secretary may by order, at the time of approval or clearance of a device or at any time thereafter, require a manufacturer to conduct postmarket ...
Postmarket Surveillance Under Section 522 of the Federal Food ...
I. Background. Section 522 of the FD&C Act (21 U.S.C. 360 l) provides FDA with the authority to require manufacturers to conduct postmarket ...
Page 301 TITLE 21—FOOD AND DRUGS § 360l §360k. State and ...
4525, provided that: ''Subsection (m) of section 520 of the. Federal Food, Drug, and Cosmetic Act [21 U.S.C.. 360j(m)], as added by the amendment made by sub-.
Section 522 of the FD&C Act, 21 U.S.C. § 360l, authorizes FDA to require postmarket surveillance in the following instances: • a class II or ...
21 U.S. Code § 360 - Registration of producers of drugs or devices
such other classes of persons as the Secretary may by regulation exempt from the application of this section upon a finding that registration by such classes of ...
21 USC 360i: Records and reports on devices - U.S. Code
... section or section 360l of this title, if-. (A) the project has demonstrated success in capturing relevant adverse event information; and. (B) the Secretary ...
21 USC 360 - General provisions respecting control of devices ...
§ 360l. Postmarket surveillance; § 360m ... section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. ... (A) The provisions of section 310.545 of title 21 ...
Postmarket Surveillance Under Section 522 of the Federal Food ...
... section 522 orders, by providing: an overview of section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l),; information on ...
21 CFR §822 Postmarket Surveillance - Code of Federal Regulations
PART 822 - POSTMARKET SURVEILLANCE Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374. Source: 67 FR 38887, June 6, 2002, unless ...
CFR - Code of Federal Regulations Title 21 - FDA
331, 352, 360i, 360l, 371, 374. Source: 67 FR 38887, June 6, 2002, unless otherwise noted.
21 USC 360e-3: Breakthrough devices - U.S. Code
(4) the authority of the Secretary with respect to postmarket surveillance under sections 360i(h) and 360l of this title. (June 25, 1938, ch. 675, §515B ...
21 CFR Part 820 Subpart A -- General Provisions - eCFR
351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383). The failure to comply with any applicable provision in this part renders a device ...
21 CFR Part 822 Subpart C -- Postmarket Surveillance Plan - eCFR
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-822 ... 21 U.S.C. 331, 352, 360i, 360l, 371, 374. Source: 67 FR 38887, June 6, 2002 ...
CFR Citation: 21 CFR 862.2100 21 CFR 880.6310 21 CFR 892.2010. Legal ... 360l 21 U.S.C. 371. Legal Deadline: None. Timetable: Action, Date, FR Cite. NPRM ...
Public Law 108–214 108th Congress An Act
21 USC 360l note. 21 USC 379i,. 379j. 21 USC 379j note. VerDate 11-MAY-2000 14:47 Nov 09, 2005 Jkt 029194 PO 00000 Frm 00575 Fmt 6580 Sfmt 6581 C:\STATUTES ...
21 U.S.C. 352 - UMKC School of Law
The requirements set forth in section 290aa-4(a) or in section ... 21, 1997, 111 Stat. 2327. (e) Designation of drugs ... section 360l of this title.