| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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051
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Date of Entry 01/14/2019
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FR Recognition Number
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7-269
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| Standard | |
CLSI MM23-1st Edition
Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms) |
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Scope/Abstract| This guideline covers the current state of molecular diagnostic techniques intended for the characterization of solid tumors, and covers a range of clinical applications including diagnosis, prognosis, therapeutic response prediction for available drugs and those still in clinical trials, as well as monitoring and presymptomatic and predisposition testing. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Section 1.4.2 Definitions of correlated biomarker, integral biomarker, and integrated biomarker.
Section 2.1.3 Prognosis, Sentence 25-26 addressing genetic mutations
Table 3 Examples of Correlation of Somatic Changes with Response to Therapy
Table 4 Selected Germline Genetic Variants Used to Predict Optimal Dosage
Section 2.4.3 Establishing Clinical Validity
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Section 1.4.2 conflicts with an existing published final guidance, see Section III.D.3. and Section III.G.1 in the guidance #1 listed below.
Section 2.1.3 conflicts with an existing published final guidance document, see Section IV C in guidance #1 listed below.
Table 3 conflicts with an existing published final guidance document, see Section IV C in guidance #1 listed below.
Table 4 conflicts with an existing published final guidance document, see Section IV C in guidance #1 listed below.
Section 2.4.3 conflicts with terminology in an FDA Educational Module Series, see proceedings listed below. |
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Relevant FDA Guidance and/or Supportive Publications*
1.In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff, Issued August 2014.
2.Biomarker Qualification Program Educational Module Series - Module 1. Biomarker Terminology: Speaking the Same Language.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
