Special 510k - Data Results of the Design Verification and Validation

D

drewsky1

#1
I am writing a Special 510k and wanted to know from others who may have written one. Is it necessary to include data results of the design verification and validation testing OR is it adequate to include for Des Verification the specification, test methodology/description, and acceptance criteria? And for Des Validation, include the customer specification, acceptance criteria and method. We will, of course, declare conformity to design control procedures as specified in 21 CRF 820.30. I don't think data results is necessary but wanted to make sure before we submit. Any input would be greatly appreciated.

Thanks,
Mijenca:):thanx:
 
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Ronen E

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#2
I am writing a Special 510k and wanted to know from others who may have written one. Is it necessary to include data results of the design verification and validation testing OR is it adequate to include for Des Verification the specification, test methodology/description, and acceptance criteria? And for Des Validation, include the customer specification, acceptance criteria and method. We will, of course, declare conformity to design control procedures as specified in 21 CRF 820.30. I don't think data results is necessary but wanted to make sure before we submit. Any input would be greatly appreciated.

Thanks,
Mijenca:):thanx:
Hi,

It is sufficient [or at least was sufficient in a special 510(k) case I was involved in, a few years ago] to include the following declaration:

"I hereby declare that as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met."

Signed by a responsible and authorized individual in the organization.

Then you include a brief risk analysis to show what V&V activities were actually required [we used FMEA], and detail for each the test method and acceptance criteria.

Cheers,
Ronen.
 
D

drewsky1

#3
Thanks Ronen for your input. What you describe is exactly what we are doing. I did question a colleague who recently submitted a Special 510k and included the results of the testing. Reason for my querie. I don't think including the result of testing is necessary as a declaration of conformity from the VP confirms this.
Mijenca
 
B

blewispunk

#4
One caveat - If this is a software device have a look at the Guidance for the content of premarket submissions for software contained in medical devices document.

The following is what is required for software devices:

For a premarket submission to qualify for review under the Special 510(k) Program, the device should be a modification of your 510(k) cleared device that you own, where the modification does not alter the intended use or the fundamental scientific technology of the devicevii. In a Special 510(k), you should follow the recommendations in this guidance on the documentation to submit, but submit only the documentation related to the modification that prompted the submission. For example, when submitting the documentation of requirements and specifications in a Special 510(k), the documentation should focus on the modifications and may not necessarily include all of the requirements and specifications of the entire device.

We recommend that you submit the regression testing performed to verify and validate the modifications. We recommend that you submit your test plans, pass/fail criteria, and summary results rather than test data. In all cases, the type of software-related documentation and the level of detail you provide should be appropriate to the Level of Concern associated with your device in the context of the modifications. Since a Special 510(k) submission relies on your declaration of conformance to design controls, we believe you cannot properly submit a Special 510(k) until you have completed testing or other activities relied on by your declaration (see section 514(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. 360d(c)(1)(B)).
 
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