Aug 25, 2020

Medical device regulators at the US Food and Drug Administration have issued final guidance for two device types now qualified to obtain faster market access via the agency’s Safety and Performance Based Pathway.

The two final guidances cover cutaneous electrodes for recording purposes and conventional foley catheters, both Class II devices under the FDA classification system, respectively. Finalized in 2019, the Safety and Performance Based Pathway was developed by US regulators to expand the Abbreviated 510(k) program to provide expedited FDA premarket review for well-understood devices.

Key criteria for FDA Safety and Performance Based Pathway qualification

FDA has set the following high-level criteria for determining which devices qualify for premarket review under the Safety and Performance Based Pathway:

  • Device has same indications for use as its identified predicate device
  • Device’s technical characteristics should not result in different safety and effectiveness profile than that of its predicate device
  • Device must meet specific performance criteria laid out by FDA

Performance criteria for cutaneous electrodes, Foley catheters

For cutaneous electrode devices, FDA final guidance covers only those devices intended for non-invasive recording of physiological signals. The FDA final guidance for Foley catheters targets only those devices intended for urinary tract drainage or irrigation; these are Class II devices with product code EZL (Catheter, Retention Type, Balloon).

The guidances state that manufacturers of qualifying devices are not required to submit data on direct comparison testing against their predicate devices; test result summaries and declarations of conformity to relevant standards for safety, performance and sterilization.

For biocompatibility evaluations of these devices, manufacturers should reference FDA’s guidance on the ISO 10993-1 standard for biological evaluation of medical devices, and use Attachment A from the guidance for assessing endpoints including cytotoxicity, sensitization and irritation. For devices utilizing the same raw materials and manufacturing processes as their predicates, premarket applicants may submit documentation outlined in Attachment F of the ISO 10993 guidance in lieu of actual biocompatibility testing.

Emergo by UL will provide additional reporting as FDA identifies more device types eligible for its Safety and Performance Based Pathway.

Learn more about US FDA medical device regulatory issues:

  • FDA 510(k) consulting for medical device and IVD manufacturers
  • FDA medical device classification consulting
  • Whitepaper: Determining Substantial Equivalence for FDA 510(k) clearance
  • Whitepaper: Medical device testing requirements for 510(k) submissions


  • Stewart Eisenhart