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?