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Device Safety Evaluation

  • Shayne C. GadEmail author
Chapter

Abstract

To an even greater extent than is the case with pharmaceuticals, the regulatory ­nonclinical safety assessment requirement (called, for devices, biocompatability evaluation) has become globally harmonized. The primary guidance for the USA, EU, and Japan and associated countries have formally become the ISO 10993 ­standards, with each having reference to their own regulations only in special cases. The remainder of the world has chosen to follow suit, making adherence of testing to support a submission primarily by reference to the International Standards Organization (ISO).

Keywords

Medical Device International Standard Organization United States Pharmacopeia Reproductive Toxicity Investigational Device Exemption 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

Strategies for Development

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Device Guidelines

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ISO

  1. AAMI TIR19:1998 & TIR 19/A1:1999, Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residualsGoogle Scholar
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  21. ANSI/AAMI/ISO 14155-2:2003, Clinical investigation of medical devices for human subjects-Part 2: Clinical investigation plansGoogle Scholar

Other

  1. PowerPoint Slides: Overview of Medical Devices Submission, Yuko TakahashiGoogle Scholar
  2. PowerPoint Slides: Medical Devices: Clinical Trials, Peter RuysGoogle Scholar
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FDA Regulations

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Japan

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  5. The Society of Japanese Pharmacopoeia, 13th ed., Yakuji Nippo, LTD., Japan, 1996.Google Scholar
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Appendices

  1. FDA, Good Clinical Practice in FDA-regulated Clinical Trials, http://www.fda.gov/oc/gcp/
  2. FDA, Introduction: Good Clinical Practice, http://www.fda.gov/cdrh/devadvice/ide/index.shtml#gcp
  3. ICH, Guideline for Good Clinical Practice (E6), http://www.ich.org/LOB/media/MEDIA482.pdf
  4. Ohno, Y. (2002) ICH Guidelines-Implementation of the 3Rs (Refinement, Reduction, and Replacement): Incorporating Best Scientific Practices into the Regulatory Process, ILAR Journal, Vol. 43, supplement, http://dels.nas.edu/ilar_n/ilarjournal/43_supp/v43supOhno.pdf
  5. PowerPoint Slides: GCP and Post Marketing Surveillance Requirements, Janet VessotskieGoogle Scholar

Forms

  1. FDA, Medical Device Reporting-Forms and Instructions, http://www.fda.gov/cdrh/mdr/mdr-forms.html
  2. FDA, Device Evaluation Information-Forms, http://www.fda.gov/cdrh/ode/ode-forms.html

Acronyms

  1. FDA, FDA/CVM-Related Acronyms and Abbreviations, http://www.fda.gov/cvm/acronym.htm
  2. *A-Z Acronym List, The CDER Handbook, http://www.fda.gov/cder/handbook/
  3. Acronyms, Abbreviations, and Initials, Applied Clinical Trials (Act Magazine), Special Resource Issue, http://www.cdisc.org/glossary/Acronymsv4.pdf, 2005

Websites

  1. CenterWatch Clinical Trials Listing Service, http://www.centerwatch.com
  2. Drug Information Resources-Ebling Library (provides many links to some of the websites in this list) http://www.hsl.wisc.edu/subject_guides_toolkits/subject_guides/drug_info/index.cfm
  3. Regulatory Affairs Professionals Society, www.raps.org
  4. FDA Drug Approvals List, http://www.fda.gov/cder/da/da.htm
  5. Drug Information Association, http://www.diahome.org/en/
  6. National Institute on Drug Abuse, http://www.nida.nih.gov/drugpages.html
  7. CDER, Regulatory Information, http://www.fda.gov/cder/regulatory/default.htm
  8. The Food and Drug Law Institute, http://www.fdli.org/
  9. Institute for Safe Medication Practices, http://www.ismp.org/default.asp
  10. FDA Medical Bulletin (1996–1999), http://www.fda.gov/medbull/mblistin.html
  11. MedWatch Safety Information, http://www.fda.gov/medwatch/safety.htm
  12. Health Insite (Australian, contains many links), http://www.healthinsite.gov.au
  13. FDA Databases (see medical device list) http://www.fda.gov/search/databases.html
  14. Medical Device Reporting-Forms and Instructions, http://www.fda.gov/cdrh/mdr/mdr-forms.html
  15. FDA, Device Advice, Clinical Trials and IDE Guidance Documents, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIDE/da_ide_topic.cfm
  16. FDA, Device Evaluation Information-Forms, http://www.fda.gov/cdrh/ode/ode-forms.html
  17. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), http://www.ich.org/cache/compo/276-254-1.html

Unclassified Sources

  1. Books/publicationsGoogle Scholar
  2. Alder, S. and Zbinden G. (1988) National and International Drug Safety Guidelines, M.T.C. Verlag, ZollikonGoogle Scholar
  3. Regulatory Affairs Professionals Society, 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004Google Scholar

Other

  1. Australia and NZ Set Schedule for Joint Regulatory Agency, Ref: 24213, Script Daily News Alert, 10/04/2006Google Scholar
  2. Ohno, Y. ICH Guidelines-Implementation of the 3Rs (Refinement, Reduction, and Replacement): Incorporating Best Scientific Practices into the Regulatory Process, ILAR Journal, Vol. 43, supplement, 2002Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  1. 1.Gad Consulting ServicesCaryUSA

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