Consulting with FDA under the Pre-Sub process before submitting a 510(k)/ De Novo

By Dalia Givony

Manufacturer of medical devices and IVDs can obtain FDA feedback before investing their resources in expensive preclinical evaluation and clinical studies intended to support a premarket submission or an IDE.

When submitting a Pre-Sub for a 510(k) or a De Novo, the Pre-Sub file should include a cover letter, device intended use/indication for use, device description, proposed predicate device, bench/ analytical evaluation, preclinical & clinical study protocol, previous discussions with FDA, specific questions to FDA and the requested method of feedback (written response, face to face meeting or teleconference with FDA).

Pre-Sub is strongly recommended in situations when specific questions arise that are not adequately addressed by existing guidance or when the new device does not clearly fall within an established regulatory pathway.

Examples for specific questions for a 510(k) Pre-Sub:

·        Are there concerns with the proposed predicate device?

·        Are the proposed clinical trial design and selected control group appropriate?

·        Are the suggested bench tests and standards appropriate to demonstrate safety and effectiveness?

Dalia Givony can support your company in the Pre-Sub process, from package preparation including bench/ preclinical and clinical study design to preparation for the meeting with FDA and participation in the Pre-Sub meeting.

Need help establishing your regulatory strategy and prepare a Pre-Sub?

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