New FDA Forms - 2891 Registration of Device Establishment, FDA 2892 Device Listing

[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.

(broken link removed)

There are also instruction sheets attached with each form.

Bridget

 

[Wes Bucey]

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.

(broken link removed)

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.

 

[Bridget]

FDA annual registration forms changed also

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

 

[Katydid]

Do we have to register?

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: (broken link removed)


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.

 

[Al Rosen]

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: (broken link removed)


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 (broken link removed) for more information.

 

[Katydid]

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 Rosen]

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.