In Part 1 of our blog, we discussed the introduction, background, and policy for the US Food and Drug Administration (FDA) draft guidance Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria. We will continue Part 2 of our blog with appropriate use of the Expanded Abbreviated 510(k) pathway, FDA’s identification of performance criteria, and data submission to the FDA.
A device manufacturer may use the Expanded Abbreviated 510(k) pathway if:
- The new device is similar in purpose and technology to the predicate device and would not raise additional concerns over safety and/or effectiveness.
- Performance criteria of the new device can be compared to at least one similar predicate device.
- The predicate device used for performance criteria comparison will be identified.
- The new device complies with the performance criteria.
- Further information identifying devices that may be marketed under the Expanded Abbreviated 510(k) pathway will be provided in separate performance criteria guidance documents.
- Questions regarding appropriate use of Expanded Abbreviated 510(k) may be made through the Q-Submission program. Information about requesting feedback can be found here.
- The FDA will issue a list of various types of devices aligned with the Expanded Abbreviated 510(k) program.
- The FDA website will pair each device type on the list with guidance documents describing the performance criteria, procedures for testing the criteria, and other relevant information.
- Performance criteria may utilize special controls and/or consensus standards already developed.
- The performance criteria will be designed so that if they are met, the new device would be considered at least as safe and effective as the predicate device.
- Some considerations for determining the performance criteria and appropriate testing methods are: 1) FDA expertise, 2) literary publications, and 3) existing data on marketed similar devices.
- The final decision on whether a device is substantially equivalent will be made by the FDA.
Submission of Data:
- The device manufacturer needs to submit a “declaration of conformity” that confirms that the new device meets FDA’s performance criteria and/or a summary of the data to the FDA.
- Whether the declaration and/or the summary of the data are needed depends on the methodology used to test the device.
- The FDA may request further information supporting the device has met performance criteria.
- If the FDA finds the device did not meet the performance criteria and is not substantially equivalent to the predicate, the device manufacturer may still follow one of other pathways to marketing the device.
Relying on comparative testing with predicate devices to market new devices by the legacy 510(k) pathway has limitations. As modern technology changes, devices become less like predicate devices, and demonstrating safety and effectiveness of new devices becomes more costly and time-consuming. When the draft guidance is finalized, the Expanded Abbreviated 510(k) pathway should expedite marketing of moderate risk devices, improving cost effectiveness through comparison of performance criteria rather than comparative testing, and therefore advancing the least burdensome provisions.
The comment period for the Expanded Abbreviated 510(k) draft guidance is open through July 11, 2018, and directions for comment submissions can be found here.
- The Clinical Pathways Team
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