Federal Government Activities
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
The Food and Drug Administration's (FDA) Center for Devices and
Radiological Health (CDRH) is responsible for ensuring that medical
devices are safe and effective as authorized by the 1976 Medical Device
Amendments to the Federal Food, Drug and Cosmetic Act.
FDA regulations regarding breast pumps and breast shields
- Nonpowered breast pumps are Class I devices (according to 21 CFR Part
884.5150) requiring that manufacturers register the establishment of a
new device and list that device with the Food and Drug Administration
(FDA).
- Powered breast pumps are Class II devices (21 CFR Part 884.5160).
Therefore, manufacturers must submit a premarket notification (510(k)
to the FDA and meet other requirements.
FDA regulations may be reviewed by visiting http://www.fda.gov/cdrh/devadvice.
Specifically, under the subheader "Code of Federal Regulations,"
CFR Title 21 is located at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
showCFR.cfm?CFRPart=884. From there, both powered and nonpowered
breast pumps can be found by scrolling down to Part 884.5150
and Part 884.5160.
General consumer inquiries are handled by the center's consumer staff,
who may be contacted as indicated below.
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