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FDA Expands Scope of Guidance on Presubmission Meetings
Under a new draft guidance, the FDA’s Pre-IDE Program will be renamed the Pre-Submission Program and cover a broad range of applications — from IDEs, PMAs and 510(k)s to humanitarian device exemptions, de novo filings and more. The change reflects the natural expansion of the agency’s Pre-IDE Program, which over time has evolved to include early feedback on a host of non-IDE submissions, the FDA explains in a Friday Federal Register notice.
Devices & Diagnostics Letter |
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