Investigational Device Exemption (IDE) Preparation and Submission to FDA

Company Situation

The Client is a China based invitro diagnostic kits manufacturer planning to launch its IVD kits for Human Papilomavirus (HPV) detection kits in USA and was seeking a partner to provide a clinical investigation strategy for the kit and support with preparation and submission of investigational device exemption (IDE) application to FDA.

GRP Solution

GRP has helped medical device and diagnostic products manufacturers obtain successful approvals in USA from FDA using device and IVD specific strategy that included submission of IDE applications to FDA. GRP based on its experience with similar products in the past provided client with a clinical investigation strategy to enable approval of IVD by FDA.

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More Resources:
The FDA publishes tools to facilitate the registration of cosmetic product facilities and the listing of cosmetic products.

US FDA Extends Deadline for MoCRA Complaince

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FDA Publish Additional Condition for Nonprescription Use (ACNU).

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