Sub-Contract Manufacturing of a Class II Medical Device

D

DuttonT

If we were to manufacture a device for a company other than ourselves and it is a Class II device, do we manufacture it under the other companies FDA Registration, or do we need our own Registration? Thanks.

510k needed?
 
M

MIREGMGR

A contract manufacturer does not have to register and does not list.

The company engaging you, presumably the eventual marketer of the device, must be registered...usually as a Manufacturer or a Specification Developer...and must list the device.

Most Class II devices require a 510(k). This would be obtained by the company engaging you.

As a contract manufacturer, you could not obtain a 510(k) directly. Your customer however could include in their list of services they hire you to perform, provision of support-services for their 510(k) effort such as design control and technical writing.
 
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