I received a letter mid 2005 that stated if you "1. are engaged in the manufacture, preparation, or processing of a medical device (21 CFR 807.20(a)), AND" "2. introduce the device into comercial distribution, (21 CFR 807.20(c)); then you are required to register the establishement and submit device listing forms FDA 2891 and FDA 2892 respectively. If you do not put devices into commercial distribution, you should not register your establishement or list your devices."

Has anyone else received this and if so is it really saying to stop registering as a contract manufacturer of medical devices?

As a contract sterilizer of medical devices we are required to be registered with the FDA.

I received a letter mid 2005 that stated if you "1. are engaged in the manufacture, preparation, or processing of a medical device (21 CFR 807.20(a)), AND" "2. introduce the device into comercial distribution, (21 CFR 807.20(c)); then you are required to register the establishement and submit device listing forms FDA 2891 and FDA 2892 respectively. If you do not put devices into commercial distribution, you should not register your establishement or list your devices."

Has anyone else received this and if so is it really saying to stop registering as a contract manufacturer of medical devices?
I believe the FDA will cease the inspection of contract manufacturers, requiring the sponsor to audit and verify acceptable systems. Thought the FDA website still states:

Contract Manufacturers

A person(s) that manufactures a finished device under the terms of a contract with another manufacturer is a contract manufacturer. The agreement between the manufacturers should be documented in a written contract. Contract manufacturers of finished devices shall comply with applicable requirements of the quality system and shall register their establishment with FDA. Depending on the circumstances, both the contractor and manufacturer may be held jointly responsible by FDA for the activities performed.

Sorry I cannot give you a definitive answer.

Maybe you don't have to register.
From Sec. 807.20 Who must register and submit a device list? (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=807.20)
(c) Registration and listing requirements shall not pertain to any person who:
(1) Manufacturers devices for another party who both initiated the specifications and commercially distributes the device;
(2) Sterilizes devices on a contract basis for other registered facilities who commercially distribute the devices.
(3) Acts as a wholesale distributor, as defined in 807.3(s), and who does not manufacture, repackage, process, or relabel a device.