The medical devices for which the FDA 510k or premarket notification is required from the US FDA before the marketing in the US market has to submit Traditionally or Abbreviated 510k. If the FDA has specific guidance on the device for the 510 k submission, any special control available, and voluntary consensus standards available, then the manufacturer may choose to submit the abbreviated 510 k. The contents required to be included as per the 21 CFR 807. 87.
Device-specific guidance includes the detail of the information to be submitted for the FDA review and approval. In an abbreviated 510k, a summary report should include the details of the manufacturer’s efforts to use the guidance and mention if any deviations.
A device with special controls should submit a summary report that describes how the device complies and adhere to the special controls to address a specific risk in the abbreviated 510 k. Devices that depend on the FDA-recognized standards should have the evidence for compliance to those standards in the abbreviated 510 k.
- Is it possible to submit a traditional 510 k even though they have device-specific FDA guidance available?
- On what basis we can suggest an abbreviated 510k and what is its difference from the traditional 510 k?
It is always possible to submit a traditional 510 (k) even though device-specific FDA guidance available. The Traditional 510(k) Program can be used under any circumstance to seek marketing authorization of a device through the 510(k) Program. Moreover, all 510(k)s are based on the concept of substantial equivalence (SE) to a legally marketed device.
The Abbreviated 510(k) relies on the use of guidance documents, special controls, and voluntary consensus standards. In an Abbreviated 510(k) submission, manufacturers provide summary reports based on the use of guidance documents and/or special controls, or declarations of conformity to recognized standards.
Sometimes Special Controls Guidance does not provide detailed methods for most of the recommended testing, it is likely that most test reports will be requested regardless and therefore one can opt for the traditional method of submission.
I agree with the comment above.
The Abbreviated 510(k) is chosen when guidance documents, special controls, and voluntary consensus standards are available for a particular medical device. It must include the required elements identified in 21 CFR 807.87 but under certain conditions, you may not need to submit test data.
The Traditional 510(k) can be used under any circumstance to seek marketing authorization of a device through the 510(k) Program. Hence, traditional 510(k) can be chosen even if device-specific FDA guidance available.
Generally to facilitate the FDA’s review of Abbreviated 510(k) submission, summary reports based on the use of guidance documents and/or special controls, or declarations of conformity to recognized standards are provided by the manufacturer.
An Abbreviated 510(k) provides an effective means of streamlining the review of data in a 510(k) through a FDA recognized consensus standards, special controls established by regulation and guidance documents.
If manufacturers submit Abbreviated 510(k) that relies on a guidance document should include a summary report based on the use of declarations of conformity to recognized standards or guidance documents and/or special controls to demonstrate substantial equivalence. The summary report should also include information regarding how manufacturer has used the guidance document and any deviations to be outlined.
And if FDA concludes that an Abbreviated 510(k) is not appropriate for review as submitted, then the same will be notified to the manufacturer and ask to convert the 510(k) to a Traditional 510(k). For the converted 510(k), the original receipt of date remains the start of review period.