Myrl Jeffcoat myrlj@jps.net

Thanks to Carolyn for sending the following. . .Myrl

See "Potential to reduce information required"

The gateway to require LESS information on chemicals used in the manufacturing process?? and less research information??

Presentation: New FDA Guidelines for Medical Devices

• 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

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

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

• 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

• 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

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

• 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

• 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<