Contract Manufacturer Registering with the FDA - Medical Devices - 21 CFR 807.20

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.

Frank34 said:

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?

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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?

(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.

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Thank you so much for this clarification. It makes sense.


C

Actually there is a very clear guidance to be found on the FDA website here:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm

Hi..
As per FDA regulations:
1. "Contract Manufacturer who commercially distributes the device for the specifications developer – register and list the device."

Here, what do you mean by "commercially distribute for specs developer"?

2. 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; [807.20 (c) (1)]

What does it mean? If the specifications are from A(means, design is owned by A) and B does the contract manufacturing and A sells the product on it's name (label will have A as the manufacturer), then does B needs to register with FDA?

In another case, if B owns the specifications (owns the design) and contract manufactures for A; A being the manufacturer with it's name on the product label, then does B needs establishment registration with FDA? I guess here in this case is YES.

Pls clarify.


Thanks,
Sreenu

Hello!

As a Contract Manufacturer, we will now be required to register with the FDA. We are a relatively small company; about 25% is MD& only 1 product is causing us to register - the rest are components/

Any suggestions for how to get up to speed on FDA interaction. We have 2 people who previously worked at big MD companies, however no one here really knows what we'd do if the FDA showed up. We've never had a single customer complaint / return so I'd hope that would keep us low on the radar. Thanks a bunch!!

Is your business structured around a QMS that conforms to the FDA GMPs and your customers' requirements?

If so, whoever set that up should be guiding your efforts to become more aware of the 2013 heightened responsibilities.

If not, you might want to consider hiring a consultant to do a gap analysis and get you set up.

I setup the system & indeed, it is complaint to customer req'ts & 13485; we will be formally registered in 2013. I do not have experience w/ the FDA so therein lies the inquiry.