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# Attorneys Analyze Medical Device Guidance ‘Flood’
- URL: https://www.fdaweb.com/attorneys-analyze-medical-device-guidance-flood/
- Published: 2018-09-12T12:00:00.000Z
- Updated: 2026-09-15T00:31:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142327

Attorneys **Suzan Onel** and **Jacqueline Chan** (Kleinfeld, Kaplan and Becker) say that 2018 has brought a “flood of guidance documents FDA has issued related to medical devices.” In an [alert](http://www.fdaweb.com/download.php?file=Alert-%5Fdevice%5Fguidances%5Fin%5F2018.kkb%281%29.docx), the attorneys highlight some of the most notable guidance documents issued between 1/1 and 8/30 as they relate to **(1)** implementation of legislative directives in the 21st Century Cures Act and the FDA Reauthorization Act of 2017, **(2)** CDRH strategic priorities, **(3)** premarket submissions, and **(4)** postmarket responsibilities and activities.