Keywords:
Diagnostic
Diagnostic Equipment
Manufacturing
Medical Equipment
| Federal |
U.S. Food & Drug Administration
7920 Elmbrook Dr. #102
DALLAS , TX 75247
(214)253-4952
(214)655-8100 |
| Regulation 510-K, the Food, Drug, and Cosmetic Act requires that new devices must be registered with the FDA and must be equivalent to other devices currently on the market. FDA will make this determination.
Link: http://www.fda.gov/cdrh/comp/estregls.html
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| Registration is required. NO charge. |
| If the equipment or supplies are new devices, must submit a letter to the FDA describing it. |
| FDA will also determine if the product needs to be tested. |
| Both domestic and foreign manufacturers are required to list their devices with FDA if the devices are in commercial distribution in the United States. |
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| NOTE: See MANUFACTURING regarding applicable environmental regulations. |
Wednesday, July 18, 2012 – 18:47 pm
