Tag: Clinical investigation of medical devices for human subjects — Good clinical practice

New FDA Guidance for a Risk-Based Approach to Monitoring

The new FDA Guidance document, “Guidance for Industry – Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring,” has just been released.  Released 8/2/2013, the 22 page document covers the development of risk-base monitoring strategies and plans for investigational studies of medical products.  Some examples of that would be human drug and biological products, medical devices, and combination products.

The Risk-Based Approach to Monitoring Guidance has been released to enhance human subject protection and to improve the quality of clinical trial data by focusing on the most important aspects of study conduct and reporting.  This can be done with a variety of approaches.

Users will want the Risk-Base Approach to Monitoring if they are covered by 21 CFR Part 312 or 21 CFR Part 812 (FDA Sections of the Code of Federal Regulations).  And additional insight is provided for users of ISO 14155, “Clinical investigation of medical devices for human subjects – Good clinical practice.”    While the guidance document does not establish a legally enforceable set of requirements, it does reflect the Agency’s current thinking on the topic.

The sections in this guidance document are:

  1. Introduction
  2. Background
  3. Overview of Monitoring Methods
  4. Risk-Based Monitoring
  5. Documenting Monitoring Activities
  6. Additional Strategies to Ensure Study Quality
  7. Paperwork Reduction Act of 1995

If your organization is subject to FDA oversight, you may be responsible for monitoring investigator conduct and the progress of investigational new drug (IND) or investigational device exemption (IDE) studies. The guidance reflects the growing consensus that risk-based approaches to monitoring can make such studies more effective and efficient.

To review FDA guidance documents that have been released this year, see my 2 Document Center Blogs:  FDA Guidance Documents for the 1st Quarter 2013, and today’s FDA Guidance Documents for the 2nd Quarter 2013.

If you’d like to order any of these items, please use our website, www.document-center.com.  You’ll be able to order paper copies or download the pdf file.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here to help you with all your compliance documentation requirements.

Document Center’s Top 20 Best Selling Standards for 2011

Yes, it’s the end of the year and what better time to highlight our best selling standards of 2011!  Here’s what Document Center customers wanted this year:

  1. ISO 14155, 2nd Edition and Technical Corrigendum (correction sheet) from 2011, “Clinical investigation of medical devices for human subjects – Good clinical practice”
  2. ISO 19011, 2nd Edition, 2011, “Guidelines for auditing management systems”
  3. AMS 2700, Revision E, “Passivation of Corrosion Resistant Steels”
  4. 21CFR(800-1299), 2011 Edition, “Code of Federal Regulations – Food and Drug Administration Parts 800 through 1299”
  5. BS EN ISO 14971, 2009 Edition with Corrigendum 1 (correction) from 2011, “Medical devices. Application of risk management to medical devices”
  6. ASTM F1980, 2007 R2011 Edition (reapproved in 2011), “Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices”
  7. IPC A 610, Revision E from 2010, “Acceptability of Electronic Assemblies”
  8. AS 9100, Revision C from 2011, “Quality Management Systems – Requirements for Aviation, Space & Defense Organizations”
  9. ASME Y14.5, 2009 Edition, “Dimensioning and Tolerancing”
  10. ASQ Z1.4, 2008 Edition, “Sampling Procedures and Tables for Inspection by Attributes”
  11. ASTM E1417, 2011 Edition, “Standard Practice for Liquid Penetrant Testing”
  12. ISTA 2A, 2011 Edition, “Performance Tests for Packaged-Products, Packaged-Products 150 lb (68 kg) or Less”
  13. ISO 9001, 4th Edition, Corrected and reprinted in 2009, “Quality management systems — Requirements”
  14. SOR/98-282, 2011 Edition, “Canadian Medical Devices Regulation”
  15. ASTM D4169, 2009 Edition, “Standard Practice for Performance Testing of Shipping Containers and Systems”
  16. ASTM E1444, 2011 Edition, “Standard Practice for Magnetic Particle Testing”
  17. BS EN 60601-1, 2006 Edition with Corrigendum 1 (correction sheet) from 2011, “Medical electrical equipment. General requirements for safety”
  18. ISO 10993-1, 4th Edition with Technical Corrigendum 1 (correction sheet) from 2011, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”
  19. ISO 13485, 2nd Edition with Technical Corrigendum 1 (correction sheet) from 2009, “Medical devices – Quality management systems – Requirements for regulatory purposes”
  20. ASTM A240, 2011a Edition, “Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications”

These documents are all available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.  We’re happy to help you with all your standards questions and requirements.

Happy New Year!

BS EN ISO 14155 2011 Edition on Human Clinical Trials for Medical Devices just released

BS EN ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice, has just been released for public distribution.  The ISO 14155:2011 standard is adopted by the European Union for meeting the requirements of the Medical Device Directive (93/42/EEC).

BS EN ISO 14155 is the standard that specifies the general requirements intended to:

  • Protect the rights, safety and well-being of human subjects
  • Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results
  • Define the responsibilities of the sponsor and principal investigator
  • Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

It does not apply to in vitro diagnostic medical devices.

The document is identical to ISO 14155:2011, but does contain 2 informative annexes that are part of the EN administrative information regarding the adoption of the ISO standard.  These 2 annexes are:

Annex ZA:  Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices and

Annex ZB:  Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EECon active implantable medical devices

The principles set forth in BS EN ISO 14155 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.

The document withdraws and replaces two documents, BS EN ISO 14155-1 and BS EN ISO 14155-2, which are now obsolete.

The new BS EN ISO 14155 can be purchased on Document Center’s website, www.document-center.com, or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Should you have any questions about this document or any other standard, please get in touch.  Our expert staff is available to help you during business hours (8 am to 5 pm California time).

New ISO 14155, 2011 2nd Edition, just released – Clinical investigation of medical devices for human subjects — Good clinical practice

Document Center now has the new ISO 14155:2011 Edition available for purchase.  The standard, titled Clinical investigation of medical devices for human subjects — Good clinical practice, withdraws and replaces both the ISO-14155-1 and the ISO-14155-2.

ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.

ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

ISO 14155:2011 does not apply to in vitro diagnostic medical devices.

This new edition, as well as all the ISO standards, is available from Document Center Inc. at our website www.document-center.com.  You can also contact us by phone at 650-591-7600, fax at 650-591-7617 or by email at info@document-center.com.  We’re always happy to help you with any standards needs you may have.