FDA's Proposed 510(k) Device Exemption Guidance: Using It To Your Advantage

It’s been a busy month for CDRH, as the center has issued at least a dozen guidances and draft guidances so far in August. One that came out very early in the month — called Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements — was pretty easy to ignore, especially if your technology doesn’t fall into one of the specific product codes outlined in the guidance. But you could be making a pretty big mistake by overlooking it, and Michael Drues, Ph.D., president of Vascular Sciences, explains why in this podcast. Dr. Drues is author of the Med Device Online guest column series Guerilla Regulatory Strategy and regular contributor on regulatory matters.

For More Information:

• FDA Draft Guidance: Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements [PDF]
• Webinar: Medical Device Regulatory Affairs 101 — Regulatory Affairs For Non-Regulatory Personnel
• Contact Michael Drues via email or on LinkedIn.

Music credit: Morning Blue (Instrumental) (Josh Woodward) / CC BY 3.0