FYI- In this mornings email I learned that the FDA has new online Forms 2891 and 2892. Form 2892 now permits you to use one form for up to four product codes.

http://www.fda.gov/cdrh/reglistpage.html

There are also instruction sheets attached with each form.

Bridget

FYI- In this mornings email I learned that the FDA has new online Forms 2891 and 2892. Form 2892 now permits you to use one form for up to four product codes.

http://www.fda.gov/cdrh/reglistpage.html

There are also instruction sheets attached with each form.

Bridget
Thank you for the heads up. I hope some of our Covers find the information useful and timely.

Many of you might know by now but the annual form 2891a has been updated and provides you with a list of all of the device licenses and their numbers! My boss went ballistic thinking the form was more difficult but I set him straight in a hurry. I hope to see the FDA continue to improve.

For a new QA person the list of numbers alone is a good starting place to make sure the products are listed.

Bridget

I work for a contract manufacturer of medical devices. We make orthopaedic implants and surgical tools. We do not have design control over the products, and 100% of what we ship goes directly back to our customers. I ran across this update on the web dated June 15, 2005. I called the FDA and they told me that my location should no longer register with the FDA since we don't put our products directly to market.

Address: www.fda.gov/cdrh/registration/contract.html


Is this a new interpretation for contract manufacturers and sterilizers, or has it always been like that? My background is in automotive and I have only been working in medical for a little over 1 year so I am wondering about our status as a registered company.

I work for a contract manufacturer of medical devices. We make orthopaedic implants and surgical tools. We do not have design control over the products, and 100% of what we ship goes directly back to our customers. I ran across this update on the web dated June 15, 2005. I called the FDA and they told me that my location should no longer register with the FDA since we don't put our products directly to market.

Address: www.fda.gov/cdrh/registration/contract.html (http://www.fda.gov/cdrh/registration/contract.html)


Is this a new interpretation for contract manufacturers and sterilizers, or has it always been like that? My background is in automotive and I have only been working in medical for a little over 1 year so I am wondering about our status as a registered company.I believe it has always been that way. Look at Establishment Registration (http://www.fda.gov/cdrh/devadvice/341.html#link_2) for more information.

Al, the link you gave me states:

"This includes manufacturers, contract manufacturers, contract sterilizers, specification developers, repackagers or relabelers, reprocessors of single-use devices, remanufacturers, U.S. manufacturers of export only devices, and manufacturers of components or accessories that are sold or leased directly to the end user. "


I guess I had always read the last part of that sentence as applying only to the manufacturer after the "and" rather than applying it to all manufacturers/ processors/etc. in the sentence.

Thanks for your help!

Al, the link you gave me states:

"This includes manufacturers, contract manufacturers, contract sterilizers, specification developers, repackagers or relabelers, reprocessors of single-use devices, remanufacturers, U.S. manufacturers of export only devices, and manufacturers of components or accessories that are sold or leased directly to the end user. "


I guess I had always read the last part of that sentence as applying only to the manufacturer after the "and" rather than applying it to all manufacturers/ processors/etc. in the sentence.

Thanks for your help!That's what keeps lawyers in business.