Laboratory-Developed Tests: A Legislative and Regulatory Review.
BACKGROUND: Twenty-five years ago, the Food and Drug Administration (FDA) asserted in a draft document that "home brew" tests--now commonly referred to as laboratory-developed tests (LDTs)--are subject to the same regulatory oversight as other in vitro diagnostics (IVDs)4. In 2010, the FDA began wor...
| Publicado en: | Clinical Chemistry Vol. 63; no. 10; pp. 1575 - 1585 |
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| Autores principales: | , , , , |
| Formato: | Journal Article |
| Publicado: |
Oxford University Press / USA
2017
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=126388737&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 126388737 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00099147 10CS jtl: Clinical Chemistry issn: 00099147 maglogo: N pubinfo: dt: 2017 vid: 63 iid: 10 pid: 622 pub: Oxford University Press / USA artinfo: ui: 126388737 10.1373/clinchem.2017.275164 126388737 ppf: 1575 ppct: 10 formats: fmt: @attributes: type: P tig: atl: Laboratory-Developed Tests: A Legislative and Regulatory Review. aug: au: Genzen, Jonathan R. Mohlman, Jeffrey S. Lynch, Jerry L. Squires, Michael W. Weiss, Ronald L. affil: Department of Pathology, University of Utah, Salt Lake City, UT sug: ab: BACKGROUND: Twenty-five years ago, the Food and Drug Administration (FDA) asserted in a draft document that "home brew" tests--now commonly referred to as laboratory-developed tests (LDTs)--are subject to the same regulatory oversight as other in vitro diagnostics (IVDs)4. In 2010, the FDA began work on developing a proposed framework for future LDT oversight. Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation. While the proposed guidance has not been implemented, many questions regarding LDT oversight remain unresolved. CONTENT: This review provides an overview of federal statutes and regulations related to IVDs and clinical laboratory operations, with a focus on those potentially applicable to LDTs and proposed regulatory efforts. Sources reviewed include the Code of Federal Regulations, the Federal Register, congressional hearings, guidance and policy documents, position statements, published literature, and websites. SUMMARY: Federal statutes regarding IVDs were passed without substantive evidence of congressional consideration toward the concept of LDTs. The FDA has clear oversight authority over IVD reagents introduced into interstate commerce. A 16-year delay in publicly asserting FDA authority over LDTs, the pursuit of a draft guidance approach toward oversight, and establishment of regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) applicable to LDTs contributed to community uncertainty toward LDT oversight. Future regulatory and/or legislative efforts may be required to resolve this uncertainty. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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