Comments Regarding Draft Guidance on Electronic Submission Template for Medical Device 510(k) Submissions

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Docket Number:
FDA-2021-D-0872

CHPA welcomes FDA’s efforts to modernize and streamline the process for creating and submitting 510(k) premarket notifications and generally supports the approach described in the Draft Guidance. However, CHPA recommends that FDA clarify the following key points when finalizing the Draft Guidance.

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