The suggested content of abbreviated 510(k) submissions is identified in guidance prepared by the Center for Devices and Radiological Health on March 20, 1998, titled, “The New 510(k) Paradigm; Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notification.”
Abbreviated 510(k) submissions for In Vitro Diagnostic Calibrators should include the following:
- A coversheet clearly identifying the application as an “Abbreviated 510(k)”;
- Items required under 21 CFR 807.87, including a description of the device, the intended use of the device, and the proposed labeling for the device;
- For a submission that relies on a guidance document (e.g., IVD calibrators) and or special control(s), a summary report (see item III below) that describes how the guidance and or special control(s) were used to address the risks associated with the particular device type;
- Indications for Use enclosure.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.