1. Good Guidance Practices GGP

2. Development, Issuance, and Use of Guidance Documents nCitizen petition from the Indiana Medical Devices Manufacturers Council nFederal Register - February 27, 1997 lstandardize guidance development lprovide for public comment lclarify the intent of the guidance

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

4. Level 1 Guidance nFirst interpretations of statutory or regulatory requirements nChanges in interpretation or policy that are of more than a minor nature nAddress unusually complex or controversial issues

5. Level 1 Guidance nTen step procedure includes: lSign off by Branch, Division, Office,and Center lSign off by Office of Policy and Office of Chief Counsel l90 day public comment period lRevision after public comments lSign off by Branch, Division, Office,and Center lSign off by Office of Policy and Office of Chief Counsel

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

7. Level 2 Guidance nSix step procedure includes: lSign off by Branch, Division, and Office lDoes not require a public comment period

8. Good Guidance Practices nGuidance represents one, but not necessarily the only way to meet the requirement nGuidance 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 nCompliance Guidance Documents 1- 4 nModification Documents 1+2 nQ/A Documentation nGantry Motion nInspection Questions

11. Current Guidance Documents nPreparing for MQSA Inspections nMammography Facility Survey, Equipment Evaluation, and Medical Physicist Qualification Requirements Under MQSA nPolicy Guidance Help System www.FDA.gov/cdrh/mammography/robohelp/finalregs.htm

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

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

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