21 U.S. Code § 351 - Adulterated drugs and devices

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A drug or device shall be deemed to be adulterated—
(a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture
(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or
(2)
(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or
(B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; or
(C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess; or
(3) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
(4) if
(A) it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of section 379e (a) of this title, or
(B) it is a color additive the intended use of which in or on drugs or devices is for purposes of coloring only and is unsafe within the meaning of section 379e (a) of this title; or
(5) if it is a new animal drug which is unsafe within the meaning of section 360b of this title; or
(6) if it is an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of section 360b of this title.
(b) Strength, quality, or purity differing from official compendium
If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, except that whenever tests or methods of assay have not been prescribed in such compendium, or such tests or methods of assay as are prescribed are, in the judgment of the Secretary, insufficient for the making of such determination, the Secretary shall bring such fact to the attention of the appropriate body charged with the revision of such compendium, and if such body fails within a reasonable time to prescribe tests or methods of assay which, in the judgment of the Secretary, are sufficient for purposes of this paragraph, then the Secretary shall promulgate regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength, quality, or purity shall be made. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on its label. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia.
(c) Misrepresentation of strength, etc., where drug is unrecognized in compendium
If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
(d) Mixture with or substitution of another substance
If it is a drug and any substance has been
(1) mixed or packed therewith so as to reduce its quality or strength or
(2) substituted wholly or in part therefor.
(e) Devices not in conformity with performance standards
(1) If it is, or purports to be or is represented as, a device which is subject to a performance standard established under section 360d of this title unless such device is in all respects in conformity with such standard.
(2) If it is declared to be, purports to be, or is represented as, a device that is in conformity with any standard recognized under section 360d (c) of this title unless such device is in all respects in conformity with such standard.
(f) Certain class III devices
(1) If it is a class III device—
(A)
(i) which is required by an order issued under subsection (b) ofsection 360e of this title to have an approval under such section of an application for premarket approval and which is not exempt from section 360e of this title under section 360j (g) of this title, and
(ii)
(I) for which an application for premarket approval or a notice of completion of a product development protocol was not filed with the Secretary within the ninety-day period beginning on the date of the issuance of such order, or
(II) for which such an application was filed and approval of the application has been denied, suspended, or withdrawn, or such a notice was filed and has been declared not completed or the approval of the device under the protocol has been withdrawn;
(B)
(i) which was classified under section 360c (f) of this title into class III, which under section 360e (a) of this title is required to have in effect an approved application for premarket approval, and which is not exempt from section 360e of this title under section 360j (g) of this title, and
(ii) which has an application which has been suspended or is otherwise not in effect; or
(C) which was classified under section 360j (l) of this title into class III, which under such section is required to have in effect an approved application under section 360e of this title, and which has an application which has been suspended or is otherwise not in effect.
(2)
(A) In the case of a device classified under section 360c (f) of this title into class III and intended solely for investigational use, paragraph  [1] (1)(B) shall not apply with respect to such device during the period ending on the ninetieth day after the date of the promulgation of the regulations prescribing the procedures and conditions required by section 360j (g)(2) of this title.
(B) In the case of a device subject to an order issued under subsection (b) ofsection 360e of this title, paragraph  [1] (1) shall not apply with respect to such device during the period ending—
(i) on the last day of the thirtieth calendar month beginning after the month in which the classification of the device in class III became effective under section 360c of this title, or
(ii) on the ninetieth day after the date of the issuance of such order,
whichever occurs later.
(3) In the case of a device with respect to which a regulation was promulgated under section 360e (b) of this title prior to July 9, 2012, a reference in this subsection to an order issued under section 360e (b) of this title shall be deemed to include such regulation.
(g) Banned devices
If it is a banned device.
(h) Manufacture, packing, storage, or installation of device not in conformity with applicable requirements or conditions
If it is a device and the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformity with applicable requirements under section 360j (f)(1) of this title or an applicable condition prescribed by an order under section 360j (f)(2) of this title.
(i) Failure to comply with requirements under which device was exempted for investigational use
If it is a device for which an exemption has been granted under section 360j (g) of this title for investigational use and the person who was granted such exemption or any investigator who uses such device under such exemption fails to comply with a requirement prescribed by or under such section.
(j) Delayed, denied, or limited inspection; refusal to permit entry or inspection
If it is a drug and it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
For purposes of paragraph (a)(2)(B), the term “current good manufacturing practice” includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.


[1]  So in original. Probably should be “subparagraph”.

Source

(June 25, 1938, ch. 675, § 501,52 Stat. 1049; Pub. L. 86–618, title I, § 102(b)(1),July 12, 1960, 74 Stat. 398; Pub. L. 87–781, title I, § 101,Oct. 10, 1962, 76 Stat. 780; Pub. L. 90–399, § 101(a),July 13, 1968, 82 Stat. 343; Pub. L. 94–295, §§ 3(d), 9 (b)(1),May 28, 1976, 90 Stat. 576, 583; Pub. L. 101–629, § 9(b),Nov. 28, 1990, 104 Stat. 4521; Pub. L. 102–571, title I, § 107(8),Oct. 29, 1992, 106 Stat. 4499; Pub. L. 105–115, title I, § 121(b)(1), title II, § 204(c),Nov. 21, 1997, 111 Stat. 2320, 2336; Pub. L. 112–144, title VI, § 608(b)(2), title VII, §§ 707(a), 711,July 9, 2012, 126 Stat. 1058, 1068, 1071.)
Amendments

2012—Pub. L. 112–144, § 711, inserted concluding provisions.
Par. (f)(1)(A)(i). Pub. L. 112–144, § 608(b)(2)(A)(i), substituted “an order issued” for “a regulation promulgated”.
Par. (f)(1)(A)(ii)(I). Pub. L. 112–144, § 608(b)(2)(A)(ii), substituted “issuance of such order” for “promulgation of such regulation”.
Par. (f)(2)(B). Pub. L. 112–144, § 608(b)(2)(B), substituted “an order issued” for “a regulation promulgated” in introductory provisions and “issuance of such order” for “promulgation of such regulation” in subcl. (ii).
Par. (f)(3). Pub. L. 112–144, § 608(b)(2)(C), added subpar. (3).
Par. (j). Pub. L. 112–144, § 707(a), added par. (j).
1997—Par. (a)(2)(C). Pub. L. 105–115, § 121(b)(1), inserted “; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess;” before “or (3)”.
Par. (e). Pub. L. 105–115, § 204(c), designated existing provisions as subpar. (1) and added subpar. (2).
1992—Par. (a)(4). Pub. L. 102–571substituted “379e(a)” for “376(a)” in cls. (A) and (B).
1990—Par. (f)(1). Pub. L. 101–629, § 9(b), which directed the amendment of subpars. (A) to (C) of par. (f), was executed by making the amendments in cls. (A) to (C) of subpar. (1) of par. (f) as follows to reflect the probable intent of Congress: in cl. (A)(ii)(II), substituted “, suspended, or withdrawn” for “or withdrawn”; in cl. (B)(ii), substituted “which has an application which has been suspended or is otherwise not in effect” for “which does not have such an application in effect”; and in cl. (C), substituted “which has an application which has been suspended or is otherwise not in effect” for “which does not have such an application in effect”.
1976—Par. (a). Pub. L. 94–295, § 9(b)(1), substituted “(3) if its” for “(3) if it is a drug and its” in cl. (3), substituted “(4) if (A) it bears or contains” for “(4) if (A) it is a drug which bears or contains” in cl. (4)(A), and substituted “drugs or devices” for “drugs” in cl. (4)(B).
Pars. (e) to (i). Pub. L. 94–295, § 3(d), added pars. (e) to (i).
1968—Par. (a). Pub. L. 90–399added cls. (5) and (6).
1962—Par. (a). Pub. L. 87–781designated existing provisions of cl. (2) as (A) and added (B).
1960—Par. (a). Pub. L. 86–618substituted provisions in cl. (4) relating to unsafe color additives for provisions which related to a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 354 of this title.
Effective and Termination Dates of 1997 Amendment

Pub. L. 105–115, title I, § 121(b)(2),Nov. 21, 1997, 111 Stat. 2320, provided that: “Section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 (a)(2)(C)) shall not apply 4 years after the date of enactment of this Act [Nov. 21, 1997] or 2 years after the date on which the Secretary of Health and Human Services establishes the requirements described in subsection (c)(1)(B) [section 121(c)(1)(B) ofPub. L. 105–115, set out as a note under section 355 of this title], whichever is later.”
Amendment by Pub. L. 105–115effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 ofPub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.
Effective Date of 1968 Amendment

Amendment by Pub. L. 90–399effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) ofPub. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360b of this title.
Effective Date of 1962 Amendment; Exceptions

Amendment by Pub. L. 87–781effective on first day of seventh calendar month following October 1962, see section 107 ofPub. L. 87–781, set out as a note under section 321 of this title.
Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618effective July 12, 1960, subject to the provisions of section 203 ofPub. L. 86–618, see section 202 ofPub. L. 86–618, set out as a note under section 379e of this title.
Effective Date; Postponement

Par. (a)(4) effective Jan. 1, 1940, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date; Postponement in Certain Cases note under section 301 of this title.
Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.
Approval by Regulation Prior to July 9, 2012

Pub. L. 112–144, title VI, § 608(b)(3),July 9, 2012, 126 Stat. 1059, provided that: “The amendments made by this subsection [amending this section and section 360e of this title] shall have no effect on a regulation that was promulgated prior to the date of enactment of this Act [July 9, 2012] requiring that a device have an approval under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) of an application for premarket approval.”
Guidance

Pub. L. 112–144, title VII, § 707(b),July 9, 2012, 126 Stat. 1068, provided that: “Not later than 1 year after the date of enactment of this section [July 9, 2012], the Secretary of Health and Human Services shall issue guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351 (j)] (as added by subsection (a)).”

The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.

The most recent Classification Table update that we have noticed was Tuesday, August 13, 2013

An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.

21 USCDescription of ChangeSession YearPublic LawStatutes at Large
§ 3512012112-144 [Sec.] 711126 Stat. 1071
§ 351nt new2012112-144 [Sec.] 707(b)126 Stat. 1068
§ 3512012112-144 [Sec.] 707(a)126 Stat. 1068
§ 351nt new2012112-144 [Sec.] 608(b)(3)126 Stat. 1059
§ 3512012112-144 [Sec.] 608(b)(2)126 Stat. 1058

This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


21 CFR - Food and Drugs

21 CFR Part 2 - GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

21 CFR Part 3 - PRODUCT JURISDICTION

21 CFR Part 5 - ORGANIZATION

21 CFR Part 7 - ENFORCEMENT POLICY

21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR Part 17 - CIVIL MONEY PENALTIES HEARINGS

21 CFR Part 20 - PUBLIC INFORMATION

21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

21 CFR Part 26 - MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY

21 CFR Part 54 - FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

21 CFR Part 56 - INSTITUTIONAL REVIEW BOARDS

21 CFR Part 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

21 CFR Part 70 - COLOR ADDITIVES

21 CFR Part 71 - COLOR ADDITIVE PETITIONS

21 CFR Part 73 - LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

21 CFR Part 74 - LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

21 CFR Part 99 - DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES

21 CFR Part 200 - GENERAL

21 CFR Part 201 - LABELING

21 CFR Part 203 - PRESCRIPTION DRUG MARKETING

21 CFR Part 205 - GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS

21 CFR Part 206 - IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE

21 CFR Part 207 - REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION

21 CFR Part 208 - MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS

21 CFR Part 209 - REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT

21 CFR Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

21 CFR Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

21 CFR Part 212 - CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS

21 CFR Part 216 - PHARMACY COMPOUNDING

21 CFR Part 225 - CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

21 CFR Part 226 - CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES

21 CFR Part 299 - DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES

21 CFR Part 300 - GENERAL

21 CFR Part 310 - NEW DRUGS

21 CFR Part 312 - INVESTIGATIONAL NEW DRUG APPLICATION

21 CFR Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

21 CFR Part 315 - DIAGNOSTIC RADIOPHARMACEUTICALS

21 CFR Part 320 - BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

21 CFR Part 328 - OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL

21 CFR Part 330 - OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

21 CFR Part 331 - ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE

21 CFR Part 332 - ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 333 - TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 335 - ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 336 - ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 338 - NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 340 - STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 341 - COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 343 - INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 344 570

21 CFR Part 346 - ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 347 - SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 348 - EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 349 - OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 350 - ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 352 - SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]

21 CFR Part 355 - ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 357 - MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 358 - MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 361 - PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH

21 CFR Part 369 - INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE

21 CFR Part 500 - GENERAL

21 CFR Part 511 - NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE

21 CFR Part 514 - NEW ANIMAL DRUG APPLICATIONS

21 CFR Part 530 - EXTRALABEL DRUG USE IN ANIMALS

21 CFR Part 571 - FOOD ADDITIVE PETITIONS

21 CFR Part 600 - BIOLOGICAL PRODUCTS: GENERAL

21 CFR Part 601 - LICENSING

21 CFR Part 606 - CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

21 CFR Part 607 - ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS

21 CFR Part 610 - GENERAL BIOLOGICAL PRODUCTS STANDARDS

21 CFR Part 616

21 CFR Part 630 - GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES

21 CFR Part 640 - ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS

21 CFR Part 660 - ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS

21 CFR Part 680 - ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS

21 CFR Part 700 - GENERAL

21 CFR Part 800 - GENERAL

21 CFR Part 801 - LABELING

21 CFR Part 807 - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

21 CFR Part 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

21 CFR Part 810 - MEDICAL DEVICE RECALL AUTHORITY

21 CFR Part 812 - INVESTIGATIONAL DEVICE EXEMPTIONS

21 CFR Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES

21 CFR Part 820 - QUALITY SYSTEM REGULATION

21 CFR Part 821 - MEDICAL DEVICE TRACKING REQUIREMENTS

21 CFR Part 861 - PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT

21 CFR Part 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

21 CFR Part 864 - HEMATOLOGY AND PATHOLOGY DEVICES

21 CFR Part 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES

21 CFR Part 868 - ANESTHESIOLOGY DEVICES

21 CFR Part 870 - CARDIOVASCULAR DEVICES

21 CFR Part 872 - DENTAL DEVICES

21 CFR Part 874 - EAR, NOSE, AND THROAT DEVICES

21 CFR Part 876 - GASTROENTEROLOGY-UROLOGY DEVICES

21 CFR Part 878 - GENERAL AND PLASTIC SURGERY DEVICES

21 CFR Part 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES

21 CFR Part 882 - NEUROLOGICAL DEVICES

21 CFR Part 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES

21 CFR Part 886 - OPHTHALMIC DEVICES

21 CFR Part 888 - ORTHOPEDIC DEVICES

21 CFR Part 890 - PHYSICAL MEDICINE DEVICES

21 CFR Part 892 - RADIOLOGY DEVICES

21 CFR Part 898 - PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES

21 CFR Part 1010 - PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

21 CFR Part 1020 - PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

21 CFR Part 1030 - PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS

21 CFR Part 1040 - PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

21 CFR Part 1050 - PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS

 

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