Enhancing CLIA Act of 2026

Section 353 of the Public Health Service Act (42 U.S.C. 263a) is amended—

(1) by striking subsection (a) and inserting:

Laboratory operations shall be regulated by the Secretary under this section and not under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et. seq.).

In this section:

The term analytical validity means, with respect to an examination or procedure performed by a laboratory, the ability of the examination or procedure to provide information that is accurate and reliable with respect to the identification, measurement, detection, or calculation of the target analyte in a specimen, within a reportable range.

The term applicable standard means—

(i) for a laboratory developed test for clinical use, that the test has a reasonable assurance of analytical and clinical validity; and

(ii) for a laboratory developed test for investigational use, that the test has a reasonable assurance of analytical validity.

The term clinical use —

(i) means that an examination or procedure is used for the purpose of providing information for the diagnosis, prognosis, identification, monitoring, screening, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and

(ii) does not include—

(I) investigational use;

(II) research use; or

(III) forensic use.

The term clinical validity means, with respect to an examination or procedure performed by a laboratory, the ability of the examination or procedure to provide information that is accurate and reliable for its stated clinical purpose.

The term digital laboratory data —

(i) means digital data derived from a laboratory examination or procedure performed by a laboratory on materials taken or derived from the human body, including—

(I) a digital image derived from a glass slide;

(II) flow cytometry plots;

(III) cytogenetic karyograms;

(IV) chromatographic, mass spectrometric, clinical chemistry, immunological, hematological and microbiological data;

(V) electropherograms;

(VI) gel images;

(VII) genetic expression, array and sequencing data; and

(VIII) subsequent analyses of such data; and

(ii) is patient-specific when it is accompanied by information that can be used to identify the individual from whose specimen the information was derived.

The term investigational use means, with respect to a laboratory developed test, that the test is used in a clinical investigation, at least 1 purpose of which is to gather data to establish the clinical validity of the test.

The term laboratory or clinical laboratory means a facility for the examination of materials taken or derived from the human body, including analysis of patient-specific digital laboratory data, for clinical use or investigational use.

The term laboratory developed test —

(i) means an examination or procedure, including an examination or procedure that modifies an in vitro diagnostic device regulated under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), that is—

(I) developed in a clinical laboratory certified under this section to perform tests of high-complexity; and

(II) performed only within—

(aa) the same clinical laboratory in which it was developed; or

(bb) another clinical laboratory certified under this section to perform tests of high-complexity that is within—

(AA) the same corporate organization and has common ownership by the same parent corporation as the developing laboratory; or

(BB) a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention or other Federal public health agency, if the developing laboratory is a public health laboratory or a laboratory managed by the Centers for Disease Control and Prevention or other Federal public health agency;

(ii) does not include a protocol for an examination or procedure that is commercially distributed for performance in laboratories not under common ownership by the same parent corporation as the laboratory that developed the protocol;

(iii) is not a medical device subject to regulation under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), even if the laboratory developed test—

(I) modifies the use of a device that is lawfully marketed under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.);

(II) requires preparation or modification within the laboratory of equipment, reagents, instruments, software, or other materials for use within the laboratory;

(III) includes processes, materials, research, or intellectual property developed by third parties if the developing laboratory remains responsible for compliance with applicable requirements for laboratory developed tests under this section; or

(IV) examines a specimen that was self-collected by an individual, regardless of the setting in which the specimen was collected; and

(iv) is performed in a laboratory described in clause (i)(II) even if software used in the test is executed outside of the laboratory.

The term laboratory operations —

(i) means the conduct of examinations and other procedures on material taken or derived from the human body and associated activities, including analysis of patient-specific digital laboratory data, for a purpose described in subparagraph (E), including the development and performance of laboratory developed tests; and

(ii) includes—

(I) the preparation and transfer of equipment, reagents, instruments, software, or other materials between laboratories that are under common ownership by the same parent corporation; and

(II) the distribution of specimen collection kits for use with laboratory developed tests if the components of such specimen collection kits are intended to be used consistent with the established intended uses for which they may otherwise be lawfully distributed.

The term performance specification means a value or range of values for a characteristic of an examination or procedure, such as accuracy, precision, analytical sensitivity, analytical specificity, reportable range, or other characteristic required for test performance.

The term research use means, with respect to a laboratory developed test, that the test’s purpose is solely for analytical development or scientific research, and not for use in making clinical decisions for individual patients.;

(2) by adding at the end:

Beginning 2 years after enactment of the Enhancing CLIA Act of 2026, no laboratory may perform a laboratory developed test unless the test meets the applicable standard.

For purposes of meeting the applicable standard under this section, a laboratory developed test has a reasonable assurance of analytical validity if—

(i) the laboratory that develops the test establishes performance specifications that support the ability of the test to identify, measure, detect, calculate, or analyze 1 or more analytes, biomarkers, substances, or other targets intended to be identified, measured, detected, calculated, or analyzed by the test; and

(ii) the laboratory that performs the test, if different than the laboratory that develops the test, verifies such performance specifications prior to use.

For purposes of meeting the applicable standard under this section, a laboratory developed test has a reasonable assurance of clinical validity if the laboratory that develops the test has documented evidence, which may include 1 or more of the following that supports the ability of the laboratory developed test to reliably and accurately achieve its stated purpose—

(i) peer-reviewed literature;

(ii) clinical guidelines;

(iii) bench studies;

(iv) case studies or histories;

(v) consensus standards;

(vi) reference standards;

(vii) data registries;

(viii) postmarket data;

(ix) real world data;

(x) 1 or more clinical validation studies; or

(xi) other evidence deemed appropriate by the Secretary.

(i) At any time, a laboratory may, but is not required to, obtain 1 or more supplemental affirmations that the laboratory developed test meets the applicable standard from a third party approved under subparagraph (E), pursuant to the process in subparagraph (F). Subject to clause (ii) of this subparagraph, such supplemental affirmation does not expire.

(ii) If a third party approved under subparagraph (E) has its approval withdrawn by the Secretary, a supplemental affirmation that a laboratory developed test meets the applicable standard issued by that third party shall remain in effect for no longer than the later of—

(I) 90 days after the date that a third party notifies a laboratory under subparagraph (E)(iv) that its approval has been withdrawn; or

(II) if within 60 days of receiving the notification under subparagraph (E)(iv) the laboratory submits information to a different third party requesting a supplemental affirmation that the laboratory developed test meets the applicable standard, the date on which such approved third party determines whether the laboratory developed test meets the applicable standard under subparagraph (F)(i)(II).

Beginning 2 years after enactment of the Enhancing CLIA Act of 2026, the Secretary shall approve third parties to provide a supplemental affirmation that a laboratory developed test meets the applicable standard if—

(i) the standards and procedures applied by the third party in determining whether the laboratory developed test meets the applicable standard are determined by the Secretary to be sufficiently risk-based, rigorous, and not overly burdensome;

(ii) in the case that the third party determines under subparagraph (F)(ii)(III)(cc) that the data and information provided by the laboratory demonstrates that the laboratory developed test does not meet the applicable standard, the laboratory developed test is being offered with false or deceptive claims, or that it is probable that the test will cause serious adverse health consequences, the third party agrees to notify the Secretary within 10 days of such determination unless the laboratory stops offering, and notifies the third party that it no longer offers, the laboratory developed test;

(iii) the third party agrees to notify the Secretary at least 30 days before it changes its standards and procedures for determining that a laboratory developed test meets the applicable standard; and

(iv) if the third party has its approval withdrawn by the Secretary, the third party agrees to notify each laboratory that obtained a supplemental affirmation that the applicable standard was met for any laboratory developed test of the withdrawal within 10 days of the withdrawal.

(i) If a laboratory submits information to a third party approved by the Secretary under subparagraph (E) requesting a supplemental affirmation that a laboratory developed test meets the applicable standard, the approved third party shall within 60 calendar days of receipt of the submitted information—

(I) review the submitted information, which may include communication with the laboratory; and

(II) determine whether the laboratory developed test meets the applicable standard and communicate such determination with the laboratory as described in clause (ii).

(ii) The approved third party shall provide written notice to the laboratory of the approved third party’s determination under clause (i)(II) as follows:

(I) The approved third party shall notify the laboratory if the approved third party determines that the laboratory developed test—

(aa) meets the applicable standard; or

(bb) does not meet the applicable standard and subclauses (II) and (III) do not apply.

(II) If the approved third party determines that the laboratory developed test does not meet the applicable standard but that such determination may be resolved within a reasonable time—

(aa) the approved third party shall notify the laboratory of such determination and the reasons therefore, and allow the laboratory to seek a teleconference to discuss the finding;

(bb) the laboratory shall submit information demonstrating resolution of the determination within 60 days of receiving such notification; and

(cc) the approved third party shall make a determination within 30 days of the receipt of such submission of information as to whether the laboratory developed test continues not to meet the applicable standard.

(III) If the approved third party determines that there is a lack of credible and verifiable information supporting that the laboratory developed test meets the applicable standard, the laboratory developed test is being offered with false or deceptive claims, or that it is probable that the test will cause serious adverse health consequences—

(aa) the approved third party shall notify the laboratory of such determination and the reasons therefore, and allow the laboratory to seek a teleconference to discuss the finding;

(bb) the laboratory shall submit information demonstrating resolution of the determination within 60 days of receiving such notification; and

(cc) the approved third party shall make a determination within 30 days of the receipt of such submission of information as to whether such determination continues to apply.

(iii) In the case that the third party determines under subparagraph (F)(ii)(I)(bb) that a laboratory developed test does not meet the applicable standard, the laboratory may resubmit a request for supplemental affirmation by the same or different third party for review without prejudice at any time.

(iv) In the case that the third party determines under subparagraph (F)(ii)(III)(cc) that there is a lack of credible and verifiable information supporting the analytical or clinical validity of the laboratory developed test, the laboratory developed test is being offered with false or deceptive claims, or that it is probable that the test will cause serious adverse health consequences—

(I) the third party will not notify the Secretary of such determination if the laboratory stops performing such laboratory developed test, and notifies the third party that it has stopped performing such laboratory test, within 10 days; and

(II) the laboratory may resubmit a request for supplemental affirmation by the same or different third party for review without prejudice at any time.

A laboratory developed test shall be deemed to have obtained a supplemental affirmation that it meets the applicable standard under subparagraph (D) if it is—

(i) approved by the New York State Department of Health;

(ii) determined to be reasonable and necessary under Medicare pursuant to a favorable review of a technical assessment under the MolDX Program;

(iii) within a category of tests identified by the Secretary in regulation that shall be deemed to have obtained a supplemental approval.

(i) The Food and Drug Administration shall be deemed an approved third party under subparagraph (E).

(ii) Beginning 2 years after enactment of the Enhancing CLIA Act of 2026, a laboratory may request a supplemental affirmation from the Food and Drug Administration that a laboratory developed test for clinical use meets the applicable standard.

(iii) Any laboratory seeking supplemental affirmation from the Food and Drug Administration under clause (ii) shall pay a fee for such review that is no greater than the applicable user fee for a premarket notification submission under section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j).

(iv) If a laboratory seeks supplemental affirmation from the Food and Drug Administration under clause (ii) and pays the fee under clause (iii), the Food and Drug Administration—

(I) shall review the information for the laboratory developed test only in accordance with the standards applied by the Secretary under subparagraph (A) and the procedure applied by approved third parties under subparagraph (F); and

(II) shall not apply to the laboratory developed test the standards or other requirements that apply to devices or any other product regulated under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

Beginning 2 years after enactment of the Enhancing CLIA Act of 2026, each laboratory performing 1 or more laboratory developed tests for clinical use shall submit to the Secretary the information described in subparagraph (A) in accordance with the applicable schedule described in subparagraph (B). Such information shall be submitted electronically to the centralized database established by the Secretary under subparagraph (C). If multiple laboratories within the same corporate organization and with common ownership by the same parent corporation perform the same laboratory developed test, a corporate entity with common ownership of such laboratories may submit the information described in subparagraph (A) on behalf of such laboratories, provided that each laboratory performing a laboratory developed test is separately identified with respect to each laboratory developed test it performs.

For each laboratory developed test performed for clinical use by the laboratory, the laboratory shall submit the following information, as applicable:

(i) Name and certificate number of the laboratory.

(ii) Name and certificate number of the laboratory that developed the laboratory developed test, if different than the laboratory performing the laboratory developed test.

(iii) Name of the laboratory developed test.

(iv) Purpose of the laboratory developed test, including—

(I) analyte(s) measured;

(II) disease(s), impairment(s) or assessment(s) of the health of human beings for which the laboratory developed test is used; and

(III) for what purpose(s) the information from the laboratory developed test will be used, such as for the screening, diagnosis, prognosis, or other type of assessment.

(v) Specimen type(s) used with the laboratory developed test, which may include digital laboratory data.

(vi) Type of examination, such as biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, flow cytometric, molecular, genomic, or other type of examination.

(vii) Summary of performance specifications for the laboratory developed test.

(viii) Whether the laboratory developed test modifies the use of a device that is lawfully marketed under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and, if applicable, information identifying the specific device that is modified.

(ix) Whether the test is deemed to have a supplemental affirmation under regulations issued by the Secretary or an approved third party has supplementally affirmed that the laboratory developed test meets the applicable standard and, if the latter, the name of such approved third party.

(x) If the laboratory developed test is first performed for clinical use by the laboratory 2 or more years after enactment of the Enhancing CLIA Act of 2026, is not deemed to have a supplemental affirmation under regulations issued by the Secretary, and an approved third party has not supplementally affirmed that the test meets the applicable standard, a brief summary of the information in paragraph (1)(B)(c) that supports that the laboratory developed test has a reasonable assurance of clinical validity.

If the laboratory developed test is first performed for clinical use by the laboratory 2 or more years after the date of enactment of the Enhancing CLIA Act of 2026, the laboratory must submit the information in subparagraph (A) for the laboratory developed test by the later of—

(I) 30 days after such laboratory developed test is first performed for clinical use; or

(II) 60 days after the centralized database described in subparagraph (C) is established.

If the laboratory developed test is first performed for clinical use by the laboratory prior to the date that is 2 years after enactment of the Enhancing CLIA Act of 2026, the laboratory must submit the information in subparagraph (A) for the laboratory developed test by the later of—

(I) 3 years after enactment of the Enhancing CLIA Act of 2026; or

(II) 60 days after the centralized database described in subparagraph (C) is established.

Not later than 2 years after enactment of the Enhancing CLIA Act of 2026, the Secretary shall make available a centralized database that is designed to—

(i) provide a transparent interface on the website of the Centers for Medicare and Medicaid Services for stakeholders, to the extent permitted by applicable laws, which may include access to—

(I) information submitted by laboratories under subparagraph (A); and

(II) information about test errors submitted under paragraph (3); and

(ii) provide a secure portal for electronic submission of information under subparagraph (A) and reports of test errors under paragraph (3), which provides protections from unauthorized disclosure of information, including of—

(I) trade secret or confidential commercial financial information;

(II) information that could compromise national security; and

(III) identifiable patient data.

(i) A laboratory must update or correct the information submitted under this paragraph for a laboratory developed test within 30 days of—

(I) determining that an update or correction is necessary to maintain the accuracy of the previously submitted information; or

(II) a request from the Secretary to make a specific correction, unless the laboratory demonstrates within 21 days of such request that a correction is not necessary.

(ii) A laboratory may supplement or modify the information submitted under this paragraph for a laboratory developed test when new information becomes available.

In this section:

The term serious harm means a misdiagnosis or failure to diagnose that results in the absence, delay, or discontinuation of critical medical treatment, or administration of unnecessary medical treatment, that causes death or serious injury to the patient.

The term serious injury means an injury that—

(I) is life threatening;

(II) results in permanent impairment of a body function or permanent damage to a body structure; or

(III) necessitates further medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Beginning 2 years after enactment of the Enhancing CLIA Act of 2026, a laboratory shall submit a report not later than 5 calendar days after becoming aware of an undetected inaccurate result for a laboratory developed test for clinical use that reasonably suggests—

(i) that a laboratory developed test caused serious harm that resulted in death; or

(ii) an imminent threat to public health.

Beginning 2 years after enactment of the Enhancing CLIA Act of 2026, a laboratory shall submit quarterly reports that include any undetected inaccurate results of which the laboratory becomes aware for laboratory developed tests for clinical use that reasonably suggest that the laboratory developed test caused serious harm other than death. Such quarterly reports shall be submitted not later than the end of the quarter following the quarter in which the laboratory becomes aware of such undetected inaccurate results.

A report submitted by a laboratory under this paragraph and the Secretary’s release of such report or information does not constitute an admission by the laboratory that the laboratory developed test caused or contributed to serious harm.

(A) The criteria described in this subparagraph are that a laboratory developed test in clinical use—

(i) does not have a supplemental affirmation under paragraph (1)(D) that the applicable standard is met, and the test does not meet the applicable standard; or

(ii) has a supplemental affirmation under subparagraph (1)(D) that the applicable standard is met, and the test—

(I) is represented for a purpose that is not supported by the supplemental affirmation; and

(II) does not meet the applicable standard for such purpose.

(B) Beginning 2 years after enactment of the Enhancing CLIA Act of 2026, the Secretary may issue to the developing laboratory of a laboratory developed test a written request for information that—

(i) identifies specific scientific concerns, based on credible and verifiable information, which indicate that 1 or more of the criteria described in subparagraph (A) apply to the laboratory developed test; and

(ii) requesting information that would resolve such concern.

(C) Not later than 45 days after receiving a request for information under subparagraph (B)—

(i) the laboratory—

(I) may seek a teleconference prior to the submission of information under subclause (II) to discuss the Secretary’s request; and

(II) shall submit the information requested pursuant to subparagraph (B), and may include in such submission a request for a teleconference; and

(ii) the Secretary shall—

(I) schedule a teleconference requested under clause (i)(I); and

(II) hold a teleconference if requested within 10 days of the Secretary’s receipt of the information submitted under clause (i)(II).

(D) Upon receiving a submission under subparagraph (C), the Secretary shall—

(i) review the submitted information within 45 calendar days of such receipt, which may include communication with the laboratory; and

(ii) determine whether the criteria listed in subparagraph (A) apply to the laboratory developed test and communicate such determination with the laboratory as described in subparagraph (E).

(E) The Secretary shall provide written notice to the laboratory of the Secretary’s determination under subparagraph (D) as follows:

(i) The Secretary shall notify the laboratory if the Secretary determines that the criteria in subparagraph (A)—

(I) do not apply to the laboratory developed test; or

(II) apply to the laboratory developed test and clause (ii) does not apply.

(ii) If the Secretary determines that the criteria in subparagraph (A) apply to the laboratory developed test but that such determination may be resolved within a reasonable time, and the laboratory developed test has not previously been subject to this paragraph on the basis of the same or substantially similar concerns identified in the written request issued under subparagraph (B)—

(I) the Secretary shall notify the laboratory of such a determination and allow the laboratory to seek a teleconference to discuss the finding;

(II) the laboratory shall submit information demonstrating resolution of the determination within 60 days of receiving such notification; and

(III) the Secretary shall make a determination within 30 days of the receipt of such submission of information as to whether the criteria in subparagraph (A) continue to apply to the laboratory developed test.

(F) If the Secretary notifies the laboratory under subparagraph (E)(i)(II) or (E)(ii)(III) that the criteria in subparagraph (A) apply to the laboratory developed test, the laboratory must—

(i) cease performing the laboratory developed test until the laboratory obtains a confirmation from the Secretary under subparagraph (G) that the criteria under subparagraph (A) no longer apply to the laboratory developed test; and

(ii) instruct all laboratories within the same corporate organization and under common ownership by the same parent corporation to cease performing the laboratory developed test until the developing laboratory obtains the confirmation described in clause (i).

(G) The Secretary shall, within 30 days of receiving the information described in this subparagraph, provide a confirmation that the criteria in subparagraph (A) no longer apply to a laboratory developed test that was previously issued a notification under subparagraph (F) if the laboratory that developed the test submits evidence that—

(i) it has obtained a supplemental affirmation from an approved third party under paragraph (1)(D) that the test meets the applicable standard; and

(ii) the criteria in subparagraph (A) no longer apply to the test.

Beginning 2 years after enactment of the Enhancing CLIA Act of 2026, a laboratory developed test may not be offered for investigational use unless it meets the applicable standard for such use and the test report and all other advertising and promotional materials for the test clearly state, For investigational use only. Clinical validity has not yet been established.;

(3) in subsection (e)(2)(A)(ii) by adding at the end except that such standards shall not require that laboratory developed tests offered by the laboratory have a supplemental affirmation from any approved third party that the applicable standard has been met,;

(4) in subsection (i)(1)(C) by inserting or (r) after subsection (d); and

(5) in subsection (o) by striking the period and inserting, except that the Secretary may not delegate to the Food and Drug Administration the responsibility or authority for determining whether any laboratory developed test meets the applicable standard under subsection (r)(4) of this section. Notwithstanding the prior sentence, the Food and Drug Administration may provide a supplemental affirmation that a laboratory developed test meets the applicable standard pursuant to subsection (r)(4)(F)..

The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended—

(1) in section 201(h)(1) by striking the period after pursuant to section 520(o) and inserting or laboratory developed tests as defined in the Enhancing CLIA Act of 2026. For clarity, the term device does not include articles intended solely for medical and scientific research using materials derived from the body of man or other animals, which are not intended for any use described in subparagraphs (A) through (C)..

(2) in section 501(f)(1)(C) by striking the period at the end and inserting, except that this paragraph does not apply to a device that is distributed for use with a laboratory developed test as defined under the Enhancing CLIA Act of 2026 if the device could otherwise be lawfully distributed under this Act..

(3) in section 502(o) by striking the period at the end and inserting, except that this subsection does not apply to a device that is distributed for use with a laboratory developed test as defined under the Enhancing CLIA Act of 2026 if the device could otherwise be lawfully distributed under this Act..

Section 1862(l)(1) of the Social Security Act (42 U.S.C. 1395y(l)(1)) is amended by adding at the end, For purposes of all existing and future national coverage determinations for a clinical laboratory diagnostic test, a supplemental affirmation from any approved third party that the applicable standard has been met under section 353 of the Public Health Services Act (42 U.S.C. 263a et seq.), as amended by the Enhancing CLIA Act of 2026 shall be considered equivalent to an approval or clearance under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)..

If a diagnostic test result is required for the approval of a drug under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or the licensure of a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), such test result may be determined by use of a device regulated under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or based on a laboratory developed test with a supplemental affirmation from any approved third party under section 353 of the Public Health Services Act (42 U.S.C. 263a et seq.) as amended by this Act.

Except as otherwise provided in this section, the amendments made by this Act shall take effect immediately upon enactment.

(1) The Secretary of Health and Human Services (in this subsection referred to as the Secretary) shall take the following actions, and may expend such funds as the Secretary determines necessary to ensure an orderly transition—

(A) within 180 days of enactment, promulgate proposed regulations required under the amendments made by this Act;

(B) within 2 years of enactment, establish the centralized database for laboratory developed tests under section 353(r)(2) of the Public Health Service Act, as added by section 2(a) of this Act;

(C) within 2 years of enactment, promulgate final regulations to mitigate potential conflict of interest by organizations that provide multiple oversight services under section 353 of the Public Health Services Act (42 U.S.C. 263a), including accreditation of laboratories, proficiency testing, and supplemental affirmation for laboratory developed tests; and

(D) within 30 days of enactment, revise the definition of in vitro diagnostic products at section 809.3 of Title 21 of the Code of Federal Regulations, effective immediately, to clarify that such term—

(i) does not include laboratory developed tests as defined in subsection (a) of section 2 of this Act; and

(ii) includes protocols for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae when such protocols are— except that such protocols are not commercially distributed solely because they are published, including in public or scientific presentations, or patented.

(I) commercially distributed for performance in laboratories not under common ownership by the same parent corporation as the laboratory that developed the protocol; or

(II) commercially distributed by an entity or individual that is not a laboratory;

Notwithstanding the date on which regulations are issued under paragraph (1), no regulations issued pursuant to the amendments made by this Act shall be implemented or take effect until 2 years after enactment, except as otherwise specified in this section.

(1) This subsection applies to a laboratory developed test as defined in subsection (a) of section 2 of this Act that has—

(A) a premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e), an approved humanitarian device exemption under section 520(m) of such Act (21 U.S.C. 360j(m)), a clearance under section 510(k) of such Act (21 U.S.C. 360(k)), an authorization under section 513(f)(2) of such Act (21 U.S.C. 370c(f)(2)), an investigational device exemption under section 520(g) of such Act (21 U.S.C. 360j(g)), or a licensure under section 351 of the Public Health Service Act (42 U.S.C. 262); or

(B) a premarket approval application under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e), an application for humanitarian device exemption under section 520(m) of such Act (21 U.S.C. 360j(m)), a premarket notification under section 510(k) of such Act (21 U.S.C. 360(k)), a de novo classification request under section 513(f)(2) of such Act (21 U.S.C. 370c(f)(2)), an investigational device exemption under section 520(g) of such Act (21 U.S.C. 360j(g)), or an application for licensure under section 351 of the Public Health Service Act (42 U.S.C. 262) pending on the date of enactment.

(2) Notwithstanding any other provision of this Act, a laboratory developed test under paragraph (1) shall be a device under section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)(1)) until—

(A) if a notification is submitted under paragraph (3)(A), the date of such notification; or

(B) if a notification is submitted under paragraph (3)(B), the earlier of—

(i) approval, clearance, authorization, exemption, or licensure of a modification to such test such that it meets the definition of device under section 201(h)(1) of such Act (21 U.S.C. 321(h)(1));

(ii) 2 years after enactment;

(iii) the date a subsequent notification is submitted under paragraph (3)(A); or

(iv) 60 days after enactment if no notification is submitted under paragraph (3).

(3) For a laboratory developed test under paragraph (1), within 60 days of enactment, a laboratory may submit to the Food and Drug Administration a notification that the laboratory—

(A) does not intend to modify the test to meet the definition of a device under section 201(h)(1) of the Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)(1)); or

(B) intends to modify the test to meet the definition of a device under section 201(h)(1) of the Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)(1)).

(4) For a laboratory developed test under paragraph (1)(A), upon the applicable date in paragraph (2) that such test is no longer a device, such test is deemed to have a supplemental affirmation from the Food and Drug Administration under section 353(r)(1)(D) of the Public Health Service Act (42 U.S.C. 263a(r)(1)(D)), as added by section 2(a) of this Act, that the laboratory developed test meets the applicable standard.

No later than 180 days after enactment, the Secretary shall issue a proposed regulation to establish new types of examinations that may be performed by laboratories under section 353 of the Public Health Service Act (42 U.S.C. 263a) consistent with the current state of clinical laboratory science and technology, including the advancements with respect to molecular diagnostics, digital pathology, and next generation sequencing. Within 1 year of finalizing such regulations, the Secretary must evaluate whether additional proficiency testing programs should be approved for these new specialties under section 353(f)(3)(C) of such Act (42 U.S.C. 263a(f)(3)(C)).

If the Centers for Medicare and Medicaid Services intend to issue new or revised sub-regulatory guidance and policies related to the regulation of laboratories under section 353 of the Public Health Service Act (42 U.S.C. 263a), including new or revised State operations manuals applicable to the regulation of laboratories, it must describe such proposed action in a public report at least 90 days prior to taking such action and allow an opportunity for public comment.

The Centers for Medicare and Medicaid Services must hold regular open door forums with clinical laboratories, no less frequently than annually, to discuss issues related to the regulation of laboratories under section 353 of the Public Health Service Act (42 U.S.C. 263a).

At least once every 5 years, the Centers for Medicare and Medicaid Services must review the regulations promulgated under section 353 of the Public Health Service Act (42 U.S.C. 263a), and—

(1) issue a request for information in the Federal Register regarding whether updates to such regulations are necessary to reflect advancements in laboratory science and technology; and

(2) establish a public docket, to remain open for no less than 180 days, to solicit public comments on the request for information issued under paragraph (1).