In general, yes, an App that is a medical device requiring a 510(k) notification will also require design controls. Both of those obligations are to be met by the Specification Developer. This remains the case even if the Specification Developer outsources the development to a contract design/development firm. This is pursuant to 21 CFR 820.30(a) and FDA's Part 807 requirements. Remember that the FDA's design control regulation and requirements are driven and governed by a fundamentally different part of the FD&C Act than FDA's 510(k) requirements. While design control deliverables and 510(k) deliverables feed, and are fed by, one another, they still serve fundamentally different statutory purposes. Therefore, one doesn't supplant or obviate the need for the other.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 04-Apr-2022 06:57
From: Bedwuine Senatus
Subject: Design controls software
Hello,
I am currently working with an App developer for an App. The company will develop the App, do QA testing for the app and provide documentation for 510k submission. So, from a regulatory standpoint do i still need to have a design control software for this app...
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Bedwuine Senatus
Springfield NJ
United States
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