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You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this document contact Alexandra Wong at 301-796-6210 or by email at alexandra.wong@fda.hhs.gov.

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U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Office of In Vitro Diagnostic Device Evaluation and Safety

Division of Microbiology Devices

Preface

  1. Center for Devices and Radiological Health, Office of In Vitro Diagnostics. August 28, 2009. Guidance for Industry and FDA: Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems.
  2. Centers for Disease Control. (2009). Retrieved December 8, 2009 from http://www.cdc.gov/mrsa/
  3. Murray , P. R., Baron, E.J… [et. al] (2007). Manual of Clinical Microbiology 9 th Edition: Special Phenotype Methods for Detecting Antimicrobial Resistance (pp. 1175 – 1176). Washington, DC: ASM Press.
  4. U.S. Food and Drug Administration. (2009) Pre-IDE Program: Issues and Answers – March 25, 1999 (D99-1) IDE Guidance memorandum #D99-1.
  5. CLSI. M100 - Performance Standards for Antimicrobial Susceptibility Testing. (Most recent informational supplement). CLSI; Wayne, Pennsylvania.
  6. Clinical Laboratory Standards Institute (CLSI). 2003. Quality Control of Microbiological Transport Systems; Approved Standard M40-A.
  7. 21 CFR Parts 800 to 1299. Revised as of April 1, 2009.

SOURCE

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