April 18, 2023

Design & Development Includes Regulatory Submissions

Premarket regulatory submissions [e.g., U.S. FDA 510(k) / PMA; European Technical Documentation Submissions, Canadian Device Licensing, Australian ARTG registration, etc.] need to be driven by, and documented in association with, the design and development process and documentation.  For example, both the FDA (via the QS Regulation preamble) and ISO 13485 (clause 7.3) require that the design inputs address applicable regulatory requirements.

One of those regulatory requirements would be the corresponding premarket regulatory submission authorization, as it is not possible to fully characterize the applicable regulatory requirements without specifying the required premarket submission. Once the corresponding design input is written [e.g., “Device must be FDA 510(k)-cleared / CE-marked / Licensed in Canada / Registered on the ARTG, etc., prior to marketing”], then it would progress through the remainder of the design and development process to tie out the regulatory design input.

Updates are thereafter driven by the design change process, whereby new regulatory submissions are queued and assured.