The FDA has extended the comment period on it "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device" document until Nov. 28, according to a Mass Device report.
The document is an update to a 1997 guidance document and intends to clarify when device manufacturers should submit pre-market notification for an update or modification to device that has already been approved by the FDA.
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The document is an update to a 1997 guidance document and intends to clarify when device manufacturers should submit pre-market notification for an update or modification to device that has already been approved by the FDA.
Related Articles on the FDA:
FDA Launches Website on Safe Disposal of Used Needles and Other "Sharps"
FDA Approves Anti-Clotting Drug Xarelto
FDA Reports Increase in New Drug Approvals in FY 2011