U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use Guidance for Industry and Food and Drug Administration Staff October 2016

Final
Docket Number:
FDA-2013-D-1446
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems (SMBGs) which are for over-the-counter (OTC) home use by lay-users. FDA intends for this document to guide manufacturers in conducting appropriate performance studies and preparing 510(k) submissions for these device types.


Submit Comments

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:

Dockets Management
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-2013-D-1446.