rRT-PCR Swine Flu Panel: EUA Conditions for State and/or Local Public Health Authority(ies)
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As described in the Food and Drug Administration (FDA) final guidance entitled “Emergency Use Authorization of Medical Products” (dated July 2007), Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act, or “the Act”) requires the FDA Commissioner (to the extent practicable given the circumstances of the emergency) to establish certain conditions on an EUA authorization that the Commissioner finds necessary or appropriate to protect the public health, and permits the Commissioner to establish other conditions that he finds necessary or appropriate to protect the public health.
Pursuant to section 564 of the Act, the following conditions1 have been established for public health and other qualified laboratories, and state and/or local public health authority(ies) regarding the emergency use of rRT-PCR Swine Flu Panel:
Public Health and Other Qualified Laboratories will:
- Public health and other qualified laboratories will include with reports of the results of the rRT-PCR Swine Flu Panel, the authorized Fact Sheets for Health Care Providers and the authorized Fact Sheet for Patients.
- Qualified laboratories will perform the assay on the Roche LightCycler® 2.0 Real-time PCR system, or an Applied Biosystems 7500 Fast Dx Real-time PCR instrument, or the RUO marketed Applied Biosystems 7500 Fast Real-time PCR instrument that is validated by Applied Biosystems with regard to the updated software but only partially qualified regarding its laboratory performance (proficiency testing with the CDC sample panel not performed).
- Qualified laboratories will have a process in place for reporting test results to health care providers and federal, state and/or local public health authorities, as appropriate.
- Qualified laboratories will collect information on the performance of the assay, and report to CDC any suspected occurrence of false positive or false negative results of which qualified laboratories become aware.
State and/or Local Public Health Authority(ies) will:
- Make available additional information relating to the emergency use of the authorized rRT-PCR Swine Flu Panel that is consistent with, and does not exceed, the terms of this letter of authorization.
- Ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.
For laboratory questions, please contact email@example.com.
- For questions regarding EUA conditions, please contact: EUA.OCET@fda.hhs.gov.
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