• back  •

FDA Guidances Related to Telemedicine


The following references documents on the U.S. Food and Drug Administration's web site related to telemedicine.

  1. Telemetry Guidance:
    "Wireless Medical Telemetry Risks and Recommendations" (September 27, 2000) www.fda.gov/cdrh/comp/guidance/1173.html

"Letter: Notice of Proposed Rule Making Regarding Allocating Spectrum For Wireless Medical Telemetry" (July 29, 2000): http://www.fda.gov/cdrh/ode/fcc.pdf
     
  2. Medical Image Management:
    "Guidance for the Submission of Premarket Notifications for Medical Image Management Devices" (July 27, 2000) www.fda.gov/cdrh/ode/guidance/416.pdf
     
  3. Electromagnetic Compatibility:
    "Medical Devices and EMI: the FDA Perspective" (September 9, 1996): http://www.fda.gov/cdrh/emc/persp.html

"CDRH Medical Device Electromagnetic Compatibility Program": http://www.fda.gov/cdrh/EMC/index.html
     
  4. Software Guidance:
    "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 29, 1998): www.fda.gov/cdrh/ode/software.pdf

"FDA Policy for the Regulation of Computer Products" (November 13,1989): http://www.fda.gov/cdrh/ode/351.pdf

"Off-The-Shelf Software Use in Medical Devices" (September 9, 1999): http://www.fda.gov/cdrh/ode/otssguid.pdf

Medical Devices: General Principles of Software Validation; Final Guidance for Industry and FDA Staff; Availability
http://www.fda.gov/OHRMS/DOCKETS/98fr/011102a.htm
http://www.fda.gov/OHRMS/DOCKETS/98fr/011102a.pdf

"General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (January 11, 2002): http://www.fda.gov/cdrh/comp/guidance/938.html and
http://www.fda.gov/cdrh/comp/guidance/938.pdf
     
  5. Hazards Analysis and Risk Management:
   

"Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management--Identifying, Understanding, and Addressing Use-Related Hazards" (July 18, 2000): http://www.fda.gov/cdrh/humfac/1497.pdf

"Do It By Design: An Introduction to Human Factors in Medical Devices" (December, 1996): http://www.fda.gov/cdrh/humfac/doitpdf.pdf

"Reducing Use Error": http://www.fda.gov/cdrh/useerror/
     
  6. General Guidances:
   

Division of Small Manufacturers, International and Consumer Assistance (DSMICA) can be contacted at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. See also, "DSMA Device Advice": http://www.fda.gov/cdrh/devadvice/

"Use of Standards in Substantial Equivalence Determinations" (March 12, 2000): www.fda.gov/cdrh/ode/guidance/1131.pdf

'de novo' classification: "New Section 513(f)(2) - Evaluation of Automatic Class III Designation" (February 19, 1998): http://www.fda.gov/cdrh/modact/clasiii.pdf

"Deciding When to Submit a New 510(k) for a Change to an Existing Device" (January 10, 1997): http://www.fda.gov/cdrh/ode/510kmod.pdf

Digital mammography and tele-mammography. MQSA Regulations relevant to new mammography modalities are in 21 CFR 900: "Quality Mammography Standards (as amended)": http://www.fda.gov/cdrh/mammography/frmamcom2.html#12.

CLIA (Clinical Laboratory Improvement Amendments of 1988):
"Guidance for Administrative Procedures for CLIA Categorization" (Draft-August 14, 2000): http://www.fda.gov/cdrh/ode/guidance/1143.pdf

            

 

© 2002 American Telemedicine Association
• top • back •