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Presentation: New FDA Guidelines for Medical Devices

[link to PowerPoint version]

Larry Kessler, Sc.D.
Director, Office of Science and Engineering Laboratories
CDRH, FDA
3/23/2005

Why Change Review?

• Guidance for device review with respect to risk management can:
  • Reduce variability in requirements
  • Potentially reduce information required
  • Apply the Total Product Life Cycle concept within industry and CDRH

Expanded Guidance Initiative

• ODE-OIVD-OSEL effort
  • OSEL takes lead in education and in guidance development
• Device-specific guidance for 510(k)
• Devices selected by ODE

Guidance Development Process

• Guidance will be least burdensome
• Developed in accordance with Good Guidance Practice (GGP)
• Ample opportunity for stakeholder comment

Content of Submissions

• Fitness for safe use will be a guiding principle
• We will use requirements of ISO 14971 where possible
  • ISO 14971 provides basic process
  • Is not complete or sufficient, e.g., does not integrate post-production information into the risk management process
• Work with reviewers to meet their needs

Relevant 14971 Requirements

• No longer enough to manage individual risks
• Must also assure overall risk acceptable
• FMEA, while important, is ONE part of risk management. Top down and bottom up approaches are necessary

Residual Risk Evaluation

• Method: manufacturer’s choice
• Needs to assure all important possible harms have been managed and mitigated where possible.

RM and Premarket Review

• Consider all adverse outcomes and other harms
• Includes intended use and foreseeable misuse
• Approach should be forward and backward as an evaluation of hazards
• Causes should be sought
• Basis for concluding mitigation adequate must be documented

Conclusions

• OSEL taking the lead and working closely with ODE and OIVD
• ISO 14971 pivotal but not sufficient
  • What 14971 calls residual risk is exactly what reviewers need to have available.
• Guidance in process: it is hoped that risk mitigation will assure “safe” use<

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