1 / 14

Development and Use of Good Guidance Practices in Medical Devices Industry

Explore the issuance and application of guidance documents in the medical devices sector, including levels of guidance and procedures for development. Learn about compliance guidance, equipment evaluations, and the reauthorization of the Mammography Quality Standards Act.

elizabethcobb
Download Presentation

Development and Use of Good Guidance Practices in Medical Devices Industry

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related