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Manufacturing Process FDA FOIA

#1
Good morning everybody,

Does anyone know if can I request information about a predicate manufacturing process?

It will be used to compare my subject device with the predicate to ensure that we have the same processes and our process does not raise issues about safety and effectiveness regarding biocompatibility.

Thanks!
 
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John Broomfield

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Super Moderator
#2
Good morning everybody,

Does anyone know if can I request information about a predicate manufacturing process?

It will be used to compare my subject device with the predicate to ensure that we have the same processes and our process does not raise issues about safety and effectiveness regarding biocompatibility.

Thanks!
Steve,

Do either of these links help:

https://web.mst.edu/~chellaps/papers/08_acsac_bgwc.pdf

Find and Effectively Use Predicate Devices

Please let us know.

Thanks.
 

Watchcat

Trusted Information Resource
#4
Does anyone know if can I request information about a predicate manufacturing process?
You can request anything you want. What you will get in response to your request is another matter.

What you want is the 510(k) for the predicate. If you submit a request via FOIA, you can expect to wait a long time...often months, sometimes years. If you use FOI Services, it will cost more, but if they already have it, they will get it to you quickly. Otherwise, they have to wait for FDA to send it to them, and that can take as long as if you requested it directly. Once you get it, the manufacturing details will almost certainly be redacted as confidential and proprietary.

It's not uncommon for a 510(k) applicant to use substantial equivalence of manufacturing processes to justify the exclusion of some kinds of testing, especially biocompatibility, but that's because it's not uncommon for a 510(k) applicant to be using one of their existing devices as a predicate. In that case, they have manufacturing information for the predicate. Applicants claiming substantial equivalence to a competitor's device usually don't have that option open to them.
 
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