The guidance for FDA third party review programs for 510(k) submissions and emergency use authorization (EUA) requests was updated in November, 2024. The guidance describes FDA’s most current expectations of organizations who provide third party review of these items.

To see how these expectations may impact medical device manufacturers making 510(k) submissions and EUA requests, as well as third party reviewer organizations falling under the scope of this guidance, follow this link.

DPDC stands ready to:
    • help you discover the correct regulatory pathway for your medical device
    • understand critical regulatory frameworks associated with getting your medical device into the market
    • walk you through cumbersome submission processes.
Reach out to us at DPinfo@dpdconline.com or 804-965-3981 for a free initial consultation. We look forward to helping you navigate regulatory submissions. For more about our consultation services, click here.
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