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Good Guidance Practices

Good Guidance Practices. GGP. Development, Issuance, and Use of Guidance Documents. Citizen petition from the Indiana Medical Devices Manufacturers Council Federal Register - February 27, 1997 standardize guidance development provide for public comment clarify the intent of the guidance.

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Good Guidance Practices

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  1. Good Guidance Practices GGP

  2. Development, Issuance, and Use of Guidance Documents • Citizen petition from the Indiana Medical Devices Manufacturers Council • Federal Register - February 27, 1997 • standardize guidance development • provide for public comment • clarify the intent of the guidance

  3. Definition of Guidance Documents • Documents that relate to • the processing, content and evaluation of regulatory submissions • the design, production, manufacturing, and testing of regulated products • inspection and enforcement procedures

  4. Level 1 Guidance • First interpretations of statutory or regulatory requirements • Changes in interpretation or policy that are of more than a minor nature • Address unusually complex or controversial issues

  5. Level 1 Guidance • Ten step procedure includes: • Sign off by Branch, Division, Office ,and Center • Sign off by Office of Policy and Office of Chief Counsel • 90 day public comment period • Revision after public comments • Sign off by Branch, Division, Office ,and Center • Sign off by Office of Policy and Office of Chief Counsel

  6. Level 2 Guidance • Documents that do not meet the definition of Level 1 • Not first interpretations • Not major changes in interpretation • Not complex or controversial

  7. Level 2 Guidance • Six step procedure includes: • Sign off by Branch, Division, and Office • Does not require a public comment period

  8. Good Guidance Practices • Guidance represents one, but not necessarily the only way to meet the requirement • Guidance will appear on our Website http://www.fda.gov/cdrh/mammography Level 1 - Proposal then Final Level 2 - Final

  9. Good Guidance Practices

  10. Current Guidance Documents • Compliance Guidance Documents 1- 4 • Modification Documents 1+2 • Q/A Documentation • Gantry Motion • Inspection Questions

  11. Current Guidance Documents • Preparing for MQSA Inspections • Mammography Facility Survey, Equipment Evaluation, and MedicalPhysicist Qualification Requirements Under MQSA • Policy Guidance Help Systemwww.FDA.gov/cdrh/mammography/robohelp/finalregs.htm

  12. MQSA Reauthorization • MQSA originally authorized for 5 years • Reauthorization signed into law 10/9/98 • Extends the Act until 2002

  13. MQSA Reauthorization • Lay summaries to ALL patients • Release of original mammograms ¾ temporary and permanent • Demonstration project to evaluate less than annual inspections ¾ will not begin before April 2001

  14. ...for more Information on MQSA • MQSA Internet home page: http://www.fda.gov/cdrh/mammography • MQSA facility hotline: 1-800-838-7715 • Inspector Hotline: Helpdesk@cdrh.FDA.gov 301-827-1241

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