21 USC 360 - Susceptibility test interpretive criteria for microorganisms

View all text of Part A [§ 351 - § 360n-2]

§ 360a–2. Susceptibility test interpretive criteria for microorganisms

(a) Purpose; identification of criteria

(1) PurposeThe purpose of this section is to clarify the Secretary’s authority to—

(A) efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health, due to, among other things, the constant evolution of microorganisms that leads to the development of resistance to drugs that have been effective in decreasing morbidity and mortality for patients, which warrants unique management of antimicrobial drugs that is inappropriate for most other drugs in order to delay or prevent the development of further resistance to existing therapies;

(B) provide for public notice of the availability of recognized interpretive criteria and interpretive criteria standards; and

(C) clear under section 360(k) of this title, classify under section 360c(f)(2) of this title, or approve under section 360e of this title, antimicrobial susceptibility testing devices utilizing updated, recognized susceptibility test interpretive criteria to characterize the in vitro susceptibility of particular bacteria, fungi, or other microorganisms, as applicable, to antimicrobial drugs.

(2) Identification of criteriaThe Secretary shall identify appropriate susceptibility test interpretive criteria with respect to antimicrobial drugs—

(A) if such criteria are available on the date of approval of the drug under section 355 of this title or licensure of the drug under section 262 of title 42 (as applicable), upon such approval or licensure; or

(B) if such criteria are unavailable on such date, on the date on which such criteria are available for such drug.

(3) Bases for initial identificationThe Secretary shall identify appropriate susceptibility test interpretive criteria under paragraph (2), based on the Secretary’s review of, to the extent available and relevant—

(A) preclinical and clinical data, including pharmacokinetic, pharmacodynamic, and epidemiological data;

(B) the relationship of susceptibility test interpretive criteria to morbidity and mortality associated with the disease or condition for which such drug is used; and

(b) Susceptibility test Interpretive Criteria Website

(1) In general

(2) Listing of susceptibility test interpretive criteria standards and interpretive criteria

(A) In generalThe list described in paragraph (1) shall consist of any new or updated susceptibility test interpretive criteria standards that are—

(i) established by a nationally or internationally recognized standard development organization that—(I) establishes and maintains procedures to address potential conflicts of interest and ensure transparent decisionmaking;(II) holds open meetings to ensure that there is an opportunity for public input by interested parties, and establishes and maintains processes to ensure that such input is considered in decisionmaking; and(III) permits its standards to be made publicly available, through the National Library of Medicine or another similar source acceptable to the Secretary; and

(ii) recognized in whole, or in part, by the Secretary under subsection (c).

(B) Other listThe Interpretive Criteria Website shall, in addition to the list described in subparagraph (A), include a list of interpretive criteria, if any, that the Secretary has determined to be appropriate with respect to legally marketed antimicrobial drugs, where—

(i) the Secretary does not recognize, in whole or in part, an interpretive criteria standard described under subparagraph (A) otherwise applicable to such a drug;

(ii) the Secretary withdraws under subsection (c)(1)(A) recognition of a standard, in whole or in part, otherwise applicable to such a drug;

(iii) the Secretary approves an application under section 355 of this title or section 262 of title 42, as applicable, with respect to marketing of such a drug for which there are no relevant interpretive criteria included in a standard recognized by the Secretary under subsection (c); or

(iv) because the characteristics of such a drug differ from other drugs with the same active ingredient, the interpretive criteria with respect to such drug—(I) differ from otherwise applicable interpretive criteria included in a standard listed under subparagraph (A) or interpretive criteria otherwise listed under this subparagraph; and(II) are determined by the Secretary to be appropriate for the drug.

(i) that the website provides information about the in vitro susceptibility of bacteria, fungi, or other microorganisms, as applicable to a certain drug (or drugs);

(ii) that—(I) the safety and efficacy of such drugs in treating clinical infections due to such bacteria, fungi, or other microorganisms, as applicable, may or may not have been established in adequate and well-controlled clinical trials in order for the susceptibility information described in clause (i) to be included on the website; and(II) the clinical significance of such susceptibility information in such instances is unknown;

(iii) that the approved product labeling for specific drugs provides the uses for which the Secretary has approved the product; and

(iv) any other information that the Secretary determines appropriate to adequately convey the meaning of the data supporting the recognition or listing of susceptibility test interpretive criteria standards or susceptibility test interpretive criteria included on the website.

(3) Notice

(4) Inapplicability of misbranding provision

(5) Trade secrets and confidential information

(1) Evaluation and publication

(A) In generalBeginning on the date of the establishment of the Interpretive Criteria Website, and at least every 6 months thereafter, the Secretary shall—

(i) evaluate any appropriate new or updated susceptibility test interpretive criteria standards established by a nationally or internationally recognized standard development organization described in subsection (b)(2)(A)(i); and

(ii) publish on the public website of the Food and Drug Administration a notice—(I) withdrawing recognition of any different susceptibility test interpretive criteria standard, in whole or in part;(II) recognizing the new or updated standards;(III) recognizing one or more parts of the new or updated interpretive criteria specified in such a standard and declining to recognize the remainder of such standard; and(IV) making any necessary updates to the lists under subsection (b)(2).

(B) Upon approval of a drug

(2) Bases for updating interpretive criteria standardsIn evaluating new or updated susceptibility test interpretive criteria standards under paragraph (1)(A), the Secretary may consider—

(A) the Secretary’s determination that such a standard is not applicable to a particular drug because the characteristics of the drug differ from other drugs with the same active ingredient;

(B) information provided by interested third parties, including public comment on the annual compilation of notices published under paragraph (3);

(D) such other information or factors as the Secretary determines appropriate.

(3) Annual compilation of noticesEach year, the Secretary shall compile the notices published under paragraph (1)(A) and publish such compilation in the Federal Register and provide for public comment. If the Secretary receives comments, the Secretary shall review such comments and, if the Secretary determines appropriate, update pursuant to this subsection susceptibility test interpretive criteria standards or criteria—

(A) recognized by the Secretary under this subsection; or

(B) otherwise listed on the Interpretive Criteria Website under subsection (b)(2).

(4) Relation to section 360d(c) of this title

(5) Voluntary use of interpretive criteria

(d) Antimicrobial drug labeling

(1) Drugs marketed prior to establishment of Interpretive Criteria Website

(A) In general

(B) Labeling changes

(2) Drugs marketed subsequent to establishment of Interpretive Criteria Website

(e) Special condition for marketing of antimicrobial susceptibility testing devices

(1) In general

(2) Conditions applicable to antimicrobial susceptibility testing devicesThe conditions specified in this paragraph are the following:

(A) The device is used to make a determination of susceptibility using susceptibility test interpretive criteria that are—

(i) included in a standard recognized by the Secretary under subsection (c); or

(ii) otherwise listed on the Interpretive Criteria Website under subsection (b)(2).

(B) The labeling of such device includes statements conveying—

(i) that the device provides information about the in vitro susceptibility of bacteria, fungi, or other microorganisms, as applicable to antimicrobial drugs;

(ii) that—(I) the safety and efficacy of such drugs in treating clinical infections due to such bacteria, fungi, or other microorganisms, as applicable, may or may not have been established in adequate and well-controlled clinical trials in order for the device to report the susceptibility of such bacteria, fungi, or other microorganisms, as applicable, to such drugs; and(II) the clinical significance of such susceptibility information in those instances is unknown;

(iii) that the approved labeling for drugs tested using such a device provides the uses for which the Secretary has approved such drugs; and

(iv) any other information the Secretary determines appropriate to adequately convey the meaning of the data supporting the recognition or listing of susceptibility test interpretive criteria standards or susceptibility test interpretive criteria described in subparagraph (A).

(C) The antimicrobial susceptibility testing device meets all other requirements to be cleared under section 360(k) of this title, classified under section 360c(f)(2) of this title, or approved under section 360e of this title.

(f) DefinitionsIn this section:

(1) The term “antimicrobial susceptibility testing device” means a device that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug (or drugs).

(2) The term “qualified infectious disease product” means a qualified infectious disease product designated under section 355f(d) of this title.

(3) The term “susceptibility test interpretive criteria” means—

(A) one or more specific numerical values which characterize the susceptibility of bacteria or other microorganisms to the drug tested; and

(B) related categorizations of such susceptibility, including categorization of the drug as susceptible, intermediate, resistant, or such other term as the Secretary determines appropriate.

(4)

(A) The term “antimicrobial drug” means, subject to subparagraph (B), a systemic antibacterial or antifungal drug that—

(i) is intended for human use in the treatment of a disease or condition caused by a bacterium or fungus;

(ii) may include a qualified infectious disease product designated under section 355f(d) of this title; and

(iii) is subject to section 353(b)(1) of this title.

(B) If provided by the Secretary through regulations, such term may include—

(i) drugs other than systemic antibacterial and antifungal drugs; and

(ii) biological products (as such term is defined in section 262 of title 42) to the extent such products exhibit antimicrobial activity.

(5) The term “interpretive criteria standard” means a compilation of susceptibility test interpretive criteria developed by a standard development organization that meets the criteria set forth in subsection (b)(2)(A)(i).

(g) Rule of constructionNothing in this section shall be construed to—

(1) alter the standards of evidence under subsection (c) or (d) of section 355 of this title (including the substantial evidence standard under section 355(d) of this title) or under section 262 of title 42 (as applicable); or

(2) with respect to clearing devices under section 360(k) of this title, classifying devices under section 360c(f)(2) of this title, or approving devices under section 360e of this title—

(A) apply with respect to any drug, device, or biological product, in any context other than an antimicrobial drug and an antimicrobial susceptibility testing device that uses susceptibility test interpretive criteria to characterize and report the susceptibility of certain bacteria, fungi, or other microorganisms, as applicable, to such drug to reflect patient morbidity and mortality in accordance with this section; or

(B) unless specifically stated, have any effect on authorities provided under other sections of this chapter, including any regulations issued under such sections.

(June 25, 1938, ch. 675, § 511A, as added Pub. L. 114–255, div. A, title III, § 3044(a), Dec. 13, 2016, 130 Stat. 1114.)