About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

The Safety and Performance Based Pathway is appropriate when the FDA has determined:

  • The new device has the same indications for use as, and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate; and
  • The new device meets all the FDA-identified performance criteria.

If any of the above factors are not met, the submitter has the option to submit a Traditional, Special or Abbreviated 510(k).

The following final guidances identify performance criteria and testing methodologies for device types that are appropriate for this pathway:

  • Cutaneous Electrodes for Recording Purposes
  • Conventional Foley Catheters

The FDA will continue to issue draft and final guidance(s) to apply this Safety and Performance Based Pathway to additional types of devices with corresponding FDA-identified performance criteria. Industry may suggest device types for which the FDA should consider identifying performance criteria. For example, industry may suggest devices for which there are comprehensive FDA-recognized consensus standards. We encourage industry and other stakeholders to submit evidence-based suggestions on what the performance criteria should be for eligible device types.

The FDA issued draft guidances identifying performance criteria and testing methodologies for the following device types. Once these guidances are finalized, submitters will have the option to use the safety and performance based pathway for these device types.

  • Spinal Plating Systems
  • Orthopedic Non-Spinal Metallic Bone Screws and Washers
  • Magnetic Resonance Coils
  • Soft (Hydrophilic) Daily Wear Contact Lenses

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