FDA Gets “Interactive” In New Premarket Guidance Document
This article was originally published in The Gray Sheet
Executive Summary
A Dec. 28 final FDA guidance document lays out a path for more informal interaction between agency reviewers and device companies while preserving CDRH's options to place holds on premarket reviews
You may also be interested in...
510(k) Sponsors Should Be Wary Of Informal Talk With FDA, Attorney Says
Informal communications via telephone or e-mail before or during a 510(k) submission can be an efficient approach for sponsors, but companies should be aware of the pitfalls, says Hogan & Hartson Partner and FDA device specialist John Smith
510(k) Sponsors Should Be Wary Of Informal Talk With FDA, Attorney Says
Informal communications via telephone or e-mail before or during a 510(k) submission can be an efficient approach for sponsors, but companies should be aware of the pitfalls, says Hogan & Hartson Partner and FDA device specialist John Smith
Device Pre-Market Review Times Dropped In ’06 and ’07
FDA has been getting faster at reviewing device pre-market submissions during the past two years, according to the Office of Device Evaluation 2006-2007 annual report