Approving a Test House on a Medical Device as a part of a 510k Submission

[JoCam]

Hi All,

To enable laboratories at a University, which are neither accredited or certified, to perform a study on a medical device as a part of a 510k submission, how would I go about approving them for use to satisfy the FDA?

Your assitance with this will be very much appreciated.

Jo

 

[yodon]

There's no requirement for accreditation or certification as long as the tasks are done in accordance with the regulations.

They will be like any other service provider. You have to qualify them to perform the indicated activities. You have to ensure they have the equipment, training, ability, etc. to perform the tasks per the regulations. Thus, you have to know what that means. Applicable regulations may include 21CFR820 (QSR), 21CFR58 (GLP), 21CFR11 (ER/ES), etc. There may be others like HIPAA that need to be considered.

You'll need to assess the University to ensure that they can comply, documenting the approval just like any other supplier.

Side note: while not explicitly indicated by regulation, you'll want to be sure they follow Good Documentation Practices.

 

[Ronen E]

There's no requirement for accreditation or certification as long as the tasks are done in accordance with the regulations.

They will be like any other service provider. You have to qualify them to perform the indicated activities. You have to ensure they have the equipment, training, ability, etc. to perform the tasks per the regulations. Thus, you have to know what that means. Applicable regulations may include 21CFR820 (QSR), 21CFR58 (GLP), 21CFR11 (ER/ES), etc. There may be others like HIPAA that need to be considered.

You'll need to assess the University to ensure that they can comply, documenting the approval just like any other supplier.

Side note: while not explicitly indicated by regulation, you'll want to be sure they follow Good Documentation Practices.

I generally agree though I would use "you have to" a bit less, and instead use "you better". The only thing you "have to" is follow your own procedures and requirements on suppliers selection and approval (assuming they comply with part 820's Purchasing Controls). Using an external lab for bench studies that don't require certification is just like using your own R&D lab, for instance.

Cheers,
Ronen.

 

[JoCam]

Thank you Yoden and Ronen, your replies have confirmed my thoughts.