FDA has developed this guidance document to assist industry in preparing premarket notification submissions (510(k)s) for the instrument component of laboratory-based coagulation test system(s). FDA recognizes that multiple assays or reagents reasonably be evaluated in one submission (see also “Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products; Guidance for Industry and FDA1). Consistent with that policy, we recommend that you submit one application in the following situations:
- for a new instrument using a new assay or reagent system, or
- for a new instrument using previously cleared assay or reagent system(s), or
- for previously cleared instrument(s) using a new assay or reagent system.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
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.