FDA posts final guidance on device-specific performance criteria

Regulatory NewsRegulatory News | 11 December 2020 |  By 

FDA has released three device-specific guidance documents detailing performance criteria in support of its Safety and Performance Based Pathway. The texts cover magnetic resonance (MR) receive-only coils, spinal plating systems and non-spinal metallic bone screws.
Last year, FDA published guidance on the optional Safety and Performance Based Pathway. The text set out the agency’s thinking on a pathway intended to enable companies to show a new product is as safe and effective as a legally marketed device using FDA-identified performance criteria.
FDA went on to release draft guidance documents on the specific criteria for spinal plating systems, non-spinal metallic bone screws and two other device types later in 2019. Draft guidance on MR coils followed before the end of the year.
Now, FDA has released final versions of three of the guidance documents. The final version of the guidance on spinal plating systems hews closely to the draft, despite the Advanced Medical Technology Association stating the scope of the version released for consultation last year was “too narrow to be of significant value to companies focused on innovation.”
FDA describes testing performance criteria companies can use to evaluate their devices, rather than relying on predicate products as is typical in 510(k) filings. The guidance details different types of mechanical testing companies can use to evaluate devices, as well as accepted approaches to the evaluation of biocompatibility and the validation of sterilization and reprocessing.
FDA has made more changes to the guidance on non-spinal metallic bone screws. The final guidance lists two additional standard specifications for device design characteristics, plus changes to the section on mechanical bench testing. FDA is now advising manufacturers that their screws should be compared based on nominal diameter and is recommending the use of the screw that is most likely to fail during insertion as the subject of the driving torque test.
Some of the changes are in line with feedback from AdvaMed. The trade group used the comment period to call for the inclusion of an additional standard specification and changes to the section on the driving torque test.
The result is a guidance document that, like the final text on spinal plating systems, is largely focused on a range of tests manufacturers can perform to assess the performance of their devices. The tests are mainly mechanical, with sterilization, reprocessing and biocompatibility covered more briefly.
FDA details a different set of tests in the guidance on MR coils, reflecting the nature of the devices. In that text, the testing performance criteria cover areas such as image quality and signal to noise, as well as electrical safety. The tests are unchanged from the draft released for feedback last year, but FDA has revised some of the specifics in response to the comments it received.
Notably, the title of the guidance now states the text is focused on receive-only coils. The Medical Imaging and Technology Alliance (MITA) requested the addition of “receive-only” to the title to clarify that the guidance does not apply to all MR or detachable coils. FDA also added IEC 62464-1 to the methodologies for two imaging tests in line with the wishes of MITA.


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