Abbreviated 510 k
The medical devices for which the 510 k or premarket notification is required from the US FDA before the marketing in the US market has to submit Traditional or Abbreviated 510 k. 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 include the detail of the information to be submitted for the FDA review and approval. In an abbreviated 510 k , 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 describe how the device complies and adhere to the special controls to address a specific risk in the abbreviated 510 k. Devices that depends on the FDA recognized standards should have the evidences for the compliance to those standards in the abbreviated 510 k.
Is it possible to submit a traditional 510 k even though they have a device specific FDA guidance available?
On what basis we can suggest for 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.