Safety and Performance Based Pathway

The Safety and Performance Based Pathway (SPBP) is a special form of the 510(k) that allows comparison to defined parameters instead of a specific equivalent device. This approach already covers several established and well-understood product types at the FDA.

Background

The SPBP is designed as a special form of the 510(k) or “premarket notification.” Fundamentally, it is about discussing “substantial equivalence,” which demonstrates the sufficient and appropriate safety and effectiveness of one’s own product.

Typically, this comparative procedure is carried out using a specific “predicate device” - usually also through comparative bench testing. For SPBP products, the FDA deviates from this approach in that, instead of a specific predicate device, a product-specific selection of parameters is defined as the central benchmark for comparison. The comparative approach is thus retained, but the SPBP allows for detachment from a specific equivalent device. The FDA reserves the right to designate specific product types and identify applicable parameters. It is essential that these product types are established and very well understood.

Practical Implementation

As of July 2025, 15 specific product types have been designated for the SPBP—a complete list is available on the FDA  website. When the FDA designates a product group, a product-specific guidance document is automatically published. This includes the relevant product codes, indications, and product characteristics covered by the SPBP - along with a clear distinction from similar medical devices. For example, “Orthopedic Fracture Fixation Plates” are approved for use in the lower and upper extremities and the clavicle under the SPBP, but not for use in the jaw.

This is usually followed by a list of performance criteria, including their quantification.

Although there are no advantages in terms of reduced submission fees or shortened review times, the substantive requirements for the 510(k) submission under the SPBP are product-specific, clearly formulated, and reduce the effort involved.

By the way: The traditional approach using conventional comparative arguments to a predicate device remains possible - the choice of SPBP is therefore not mandatory, just an option.

Summary

The Safety and Performance Based Pathway represents a variant of the 510(k) approval process, in which defined parameters serve as the basis for evaluation instead of a specific equivalent device. The fee structure and review timeline correspond to the regular 510(k) process, but the substantive requirements are tailored to the product and provide clearer guidance for the applicant.