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Navigating the New FDA Guidance on Electronic Submissions for De Novo Requests: What Regulatory Professionals Need to Know

Regulatory Affairs

Navigating the New FDA Guidance on Electronic Submissions for De Novo Requests: What Regulatory Professionals Need to Know

Imane Jemal

Nov 8, 2024 12:47:40 PM

In August 2024, the FDA released significant guidance impacting the Medical Device De Novo submissio...