Obtaining Regulatory Approval to Market - Medical Device Design: Innovation from Concept to Market - page 310

that you have used the previous 13 chapters in order to ensure you have a safe, usable
medical device . You can imagine the repercussions if the competent authority finds otherwise!
14.2.2 FDA Registration
Here the process is much the same. If your product is Class I it is very likely to be 510(k)
exempt. Even some Class II devices can be 510(k) exempt so your classification process,
discussed earlier, must be comprehensive - if only to save you time and money. In this case
you need to “register” your company and “list” your devices. Note that, as with the EC
process, this does not exempt you from following proper design control procedures. On the
contrary, the FDA will take a very dim view if you do not.
If your company is based outside of the USA you must have a designated office or agent with
a U.S. address. You must have an agreed protocol with this addressee; it cannot be a PO box
number!
The first port of call is to register your establishment. To do this you must have an account.
The process is quite protracted but “How to register and list” in the medical device
sections on the FDA website is useful. You will need to decide what sort of establishment
you are ( FDA, 2012 ):
1. Contract Manufacturer - Manufactures a finished device to another establishment's
specifications.
2. Contract Sterilizer - Provides a sterilization service for another establishment's devices.
3. Foreign Exporter - Exports or offers for export to the United States (U.S.), a device
manufactured or processed by another individual, partnership, corporation or association
in a foreign country, including devices originally manufactured in the United States. A
foreign exporter must have an establishment address outside the U.S.
4. Initial Distributor - Takes first title to devices imported into the U.S. An Initial Distributor
must have a U.S. address.
5. Manufacturer - Makes by chemical, physical, biological, or other procedures, any article
that meets the definition of “device” in Section 201(h) of the Federal Food, Drug, and
Cosmetic (FD&C) Act.
6. Repackager - Packages finished devices from bulk or repackages devices made by a
manufacturer into different containers (excluding shipping containers).
7. Relabeler - Changes the content of the labeling from that supplied from the original
manufacturer for distribution under the establishment's own name. A relabeler does not
include establishments that do not change the original labeling but merely add their own
name.
8. Remanufacturer - Any person who processes, conditions, renovates, repackages, restores,
or does any other act to a finished device that significantly changes the finished device's
performance or safety specifications, or intended use.