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42 U.S.C. § 3512 — Office to assist small manufacturers of medical devices; establishment
Federal law — U.S. Code and appendices · legal_authorities
The Secretary of Health and Human Services shall establish within the Department of Health and Human Services an identifiable office to provide technical and other nonfinancial assistance to small manufacturers of medical devices to assist them in complying with the requirements of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.], as amended by this Act.
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Source file: Laws/federal/codes/united-states-code/title-42/section-3512-office-to-assist-small-manufacturers-of-medical-devices-establishment--ab1605d472.md
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Source location: Title 42, Chapter 43, § 3512; chapter-043-department-of-health-and-human-services.md
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The Secretary of Health and Human Services shall establish within the Department of Health and Human Services an identifiable office to provide technical and other nonfinancial assistance to small manufacturers of medical devices to assist them in complying with the requirements of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.], as amended by this Act.
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of sections 52 to 54 of this title—
**(a) False advertisement**
(1) The term “false advertisement” means an advertisement, other than labeling, which is misleading in a material respect; and in determining whether any advertisement is misleading, there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, sound, or any combination thereof, but also the extent to which the advertisement fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the commodity to which the advertisement relates under the conditions prescribed in said advertisement, or under such conditions as are customary or usual. No advertisement of a drug shall be deemed to be false if it is disseminated only to members of the medical profession, contains no false representation of a material fact, and includes, or is accompanied in each instance by truthful disclosure of, the formula showing quantitatively each ingredient of such drug.
(2) In the case of oleomargarine or margarine an advertisement shall be deemed misleading in a material respect if in such advertisement representations are made or suggested by statement, word, grade designation, design, device, symbol, sound, or any combination thereof, that such oleomargarine or margarine is a dairy product, except that nothing contained herein shall prevent a truthful, accurate, and full statement in any such advertisement of all the ingredients contained in such oleomargarine or margarine.
**(b) Food** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(c) Drug** T
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Classes of devices**
(1) There are established the following classes of devices intended for human use:
(A) *Class I, General Controls.—*
(i) A device for which the controls authorized by or under section 351, 352, 360, 360f, 360h, 360i, or 360j of this title or any combination of such sections are sufficient to provide reasonable assurance of the safety and effectiveness of the device.
(ii) A device for which insufficient information exists to determine that the controls referred to in clause (i) are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but because it—
(I) is not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and
(II) does not present a potential unreasonable risk of illness or injury,
is to be regulated by the controls referred to in clause (i).
(B) *Class II, Special Controls.—* — A device which cannot be classified as a class I device because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with [section 360(k) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360/k&num=0&edition=prelim)), recommendations, and other appropri
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360c
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Federal law — U.S. Code and appendices · legal_authorities
Page 30
TITLE 21—FOOD AND DRUGS
§ 301
Sec.
398.
Notices to States regarding imported food.
399.
Grants to enhance food safety.
399a.
Office of the Chief Scientist.
399b.
Office of Women’s Health.
399c.
Improving the training of State, local, terri-
torial, and tribal food safety officials.
399d.
Employee protections.
399e.
Nanotechnology.
399f.
Ensuring
adequate
information
regarding
pharmaceuticals for all populations, par-
ticularly underrepresented subpopulations,
including racial subgroups.
399g.
Food and Drug Administration Intercenter
Institutes.
399h.
National Centers of Excellence in Advanced
and Continuous Pharmaceutical Manufac-
turing.
399i.
Food and Drug Administration Working Cap-
ital Fund.
SUBCHAPTER I—SHORT TITLE
§ 301. Short title
This chapter may be cited as the Federal
Food, Drug, and Cosmetic Act.
(June 25, 1938, ch. 675, § 1, 52 Stat. 1040.)
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES
Act June 23, 1939, ch. 242, §§ 1, 2, 53 Stat. 853, 854, pro-
vided that:
‘‘[SEC. 1] (a) The effective date of the following provi-
sions of the Federal Food, Drug, and Cosmetic Act is
hereby postponed until January 1, 1940: Sections 402(c)
[342(c) of this title]; 403(e)(1) [343(e)(1) of this title];
403(g), (h), (i), (j), and (k) [343(g) to (k) of this title];
501(a), (4) [351(a)(4) of this title]; 502(b), (d), (e), (f), (g),
and (h) [352(b), (d) to (h) of this title]; 601(e) [361(e) of
this title]; and 602(b) [362(b) of this title].
‘‘(b) The Secretary of Agriculture shall promulgate
regulations further postponing to July 1, 1940[,] the ef-
fective date of the provisions of sections 403(e)(1)
[343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g)
to (k)]; 502(b), (d), (
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
Page 5911
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 3513
Sept. 19, 1964, Pub. L. 88–605, title II, § 202, 78 Stat. 979.
Oct. 11, 1963, Pub. L. 88–136, title II, § 202, 77 Stat. 244.
Aug. 14, 1962, Pub. L. 87–582, title II, § 202, 76 Stat. 379.
Sept. 22, 1961, Pub. L. 87–290, title II, § 203, 75 Stat. 608.
Sept. 2, 1960, Pub. L. 86–703, title II, § 203, 74 Stat. 773.
Aug. 14, 1959, Pub. L. 86–158, title II, § 205, 73 Stat. 355.
Aug. 1, 1958, Pub. L. 85–580, title II, § 206, 72 Stat. 473.
June 29, 1957, Pub. L. 85–67, title II, § 207, 71 Stat. 224.
June 29, 1956, ch. 477, title II, § 207, 70 Stat. 436.
Aug. 1, 1955, ch. 437, title II, § 206, 69 Stat. 410.
July 2, 1954, ch. 457, title II, § 206, 68 Stat. 445.
July 31, 1953, ch. 296, title II, § 206, 67 Stat. 257.
Section was formerly classified to section 623a of
former Title 5, Executive Departments and Govern-
ment Officers and Employees, prior to the general revi-
sion and enactment of Title 5, Government Organiza-
tion and Employees, by Pub. L. 89–554, § 1, Sept. 1, 1966,
80 Stat. 378.
§ 3509. Repealed. Pub. L. 105–362, title VI,
§ 601(a)(2)(C), Nov. 10, 1998, 112 Stat. 3285
Section, Pub. L. 91–513, title IV, § 1200, Oct. 27, 1970, 84
Stat. 1296; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93
Stat. 695; Pub. L. 103–437, § 15(m), Nov. 2, 1994, 108 Stat.
4593, related to annual report by Secretary of Health
and Human Services on statutory advisory councils.
§§ 3510, 3511. Transferred
Editorial Notes
CODIFICATION
Section 3510, Pub. L. 91–667, title II, Jan. 11, 1971, 84
Stat. 2015, which related to the Working Capital Fund,
was transferred to section 3513a of this title.
Section 3511, Pub. L. 93–282, title II, § 201, May 14, 1974,
88 Stat. 134; Pub. L. 94–371, § 8, July 26, 1976, 90 Stat.
1
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 3512
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