Posted 13 August 2020 | By
More than two years after the US Food and Drug Administration (FDA) first proposed an alternate safety and performance based pathway for certain well-understood medical devices, the agency on Thursday finalized the first two device-specific guidances establishing performance criteria to support 510(k) clearance via the new pathway.
The two final guidances provide performance criteria for cutaneous electrodes for recording purposes and conventional foley catheters. Both guidances were in the initial batch of four draft guidances FDA issued last September proposing performance criteria for specific devices, and FDA has since issued another two draft device-specific guidances. (RELATED: CDRH revamps 510(k) clearances with ‘safety and performance based pathway’, Regulatory Focus 22 January 2019; CDRH takes first step to operationalize new safety and performance based pathway, Regulatory Focus 19 September 2019).
The other guidances, which remain in draft form, provide performance criteria for orthopedic non-spinal metallic bone screws and washers, spinal plating systems, magnetic resonance (MR) coils and soft (hydrophilic) daily wear contact lenses. (RELATED: MR coils: FDA details safety and performance based pathway criteria, Regulatory Focus 6 December 2019; Contact lenses: CDRH drafts guidance on performance criteria to support 510(k)s, Regulatory Focus 3 March 2020).
While the 510(k) pathway requires device makers to demonstrate substantial equivalence to a predicate device, FDA says the new optional safety and performance based pathway builds on its abbreviated 510(k) program to give device makers the flexibility to use performance criteria and voluntary consensus standards rather than direct comparison testing against a predicate device to support 510(k) clearance.
“If a legally marketed device performs at certain levels relevant to its safety and performance for the same characteristics, FDA could find the new device as safe and effective as the legally marketed device. Instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding of substantial equivalence with data demonstrating the new device meets the level of performance of an appropriate predicate device,” FDA writes.
FDA says it revised the final guidance on conventional foley catheters in response to comments from Becton Dickenson questioning the inclusion of material-mediated pyrogenicity testing as part of the biocompatibility evaluation by clarifying that such testing should be conducted for devices labeled as “non-pyrogenic”.
The agency did not receive any comments on the cutaneous electrodes for recording purposes performance criteria guidance, which has been finalized without any substantive changes.
The two final guidances provide performance criteria for cutaneous electrodes for recording purposes and conventional foley catheters. Both guidances were in the initial batch of four draft guidances FDA issued last September proposing performance criteria for specific devices, and FDA has since issued another two draft device-specific guidances. (RELATED: CDRH revamps 510(k) clearances with ‘safety and performance based pathway’, Regulatory Focus 22 January 2019; CDRH takes first step to operationalize new safety and performance based pathway, Regulatory Focus 19 September 2019).
The other guidances, which remain in draft form, provide performance criteria for orthopedic non-spinal metallic bone screws and washers, spinal plating systems, magnetic resonance (MR) coils and soft (hydrophilic) daily wear contact lenses. (RELATED: MR coils: FDA details safety and performance based pathway criteria, Regulatory Focus 6 December 2019; Contact lenses: CDRH drafts guidance on performance criteria to support 510(k)s, Regulatory Focus 3 March 2020).
While the 510(k) pathway requires device makers to demonstrate substantial equivalence to a predicate device, FDA says the new optional safety and performance based pathway builds on its abbreviated 510(k) program to give device makers the flexibility to use performance criteria and voluntary consensus standards rather than direct comparison testing against a predicate device to support 510(k) clearance.
“If a legally marketed device performs at certain levels relevant to its safety and performance for the same characteristics, FDA could find the new device as safe and effective as the legally marketed device. Instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding of substantial equivalence with data demonstrating the new device meets the level of performance of an appropriate predicate device,” FDA writes.
FDA says it revised the final guidance on conventional foley catheters in response to comments from Becton Dickenson questioning the inclusion of material-mediated pyrogenicity testing as part of the biocompatibility evaluation by clarifying that such testing should be conducted for devices labeled as “non-pyrogenic”.
The agency did not receive any comments on the cutaneous electrodes for recording purposes performance criteria guidance, which has been finalized without any substantive changes.
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August 14, 2020 at 03:51AM
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FDA finalizes first device-specific safety and performance based pathway guidances - Regulatory Focus
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