Biomedical Engineering Reference
In-Depth Information
9. Reprocessor of Single Use Devices - Performs remanufacturing operations on a single
use device.
10. Specification Developer - Develops specifications for a device that is distributed
under the establishment's own name but performs no manufacturing. This includes
establishments that, in addition to developing specifications, also arrange for the
manufacturing of devices labeled with another establishment's name by a contract
11. U. S. manufacturer of export only devices - Manufactures medical devices that are not
sold in the U.S. and are manufactured solely for export to foreign countries.
For the purposes of this exercise your company would be likely to fall into one of two
categories: #5 - Manufacturer or #10 - Specification Developer. The FDA discriminates
between a company that both “designs and makes” and one that “designs only but has others
who make it for them.”
For the device(s) you wish to list you must know the product code (see classification rules in
previous chapters) and the regulation number. You can find the specific codes related to your
device on the FDA website; here you can download all of the product codes for all devices.
For example, Table 14.1 illustrates the codes for a retractor.
The first column is the review panel. The second column is the specific area, called the
medical specialty (described in more detail in Table 14.2 ). The product code is unique to this
generic device; the regulation number is not specific to a device but to a family of devices, as
the further two rows demonstrate.
All applications are electronic. You must have created a company account (that is, registering
your company with the FDA); once registered you will be given a unique account and then
you can start listing your devices.
Unlike the EC this is an annual process and you will need to pay an annual registration
and listing fee. Do not forget to update your registration every year (normally by 31st
Table 14.1: Example Codes for a Retractor
Retractor, All Types
Carver, Wax, Dental
Gauge, Depth, Instrument, Dental
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