- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
For review purposes of a premarket notification (510(k)) for a kit, please provide the certification stated below:
I certify that the following components of my kit are either (1) legally marketed pre-Amendments devices, (2) exempt from premarket notification (consistent with the exemption criteria described in the classification regulation(s) and the limitation of exemptions for Section 510(k) of the act (e.g., 862.9), or (3) have been found to be substantially equivalent through the premarket notification process for the use(s) for which the kit is to be intended (i.e., I am not claiming or causing a new use for the component(s)).
I further certify that these components are not purchased in "bulk", but are purchased in finished form, i.e., they are packaged, labeled, etc., consistent with their pre-Amendments, exemption, or premarket notification criteria and status.
If you cannot make the above referenced certification statements for each component of your kit, you must itemize the components without a pre-Amendments exemption, or premarket notification status. In this case we will continue our premarket notification review of these components of your kit.
If you cannot make the above referenced statement in the second paragraph for each component of your kit, you must itemize these components, state whether they are pre-Amendments, exempt, or have been found substantially equivalent through the premarket notification process, and describe how you further process them (e.g., sterilize, package/repackage, label/relabel, etc.).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.