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FMMC Briefing: Non-Binding FDA Feedback on 483 Observations
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When: Thursday, March 21, 2019
8:00 AM
Where: Hilton Carillon Park
950 Lake Carillon Drive
Salon D
St. Petersburg, Florida  33716
United States
Contact: FMMC
(850) 270-3158

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Brian Matye, CEO

Regulatory Compliance Associates
Join us to learn about the FDA's recently-released draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments" which outlines a formal pathway for device manufacturers to receive nonbinding feedback on corrective action plans in their response to Form 483 inspectional observations. The new process is intended to streamline FDA's responses so companies can address safety and quality issues as quickly and adequately as possible and avoid taking unnecessary actions that are unlikely to address the agency's observations. This timely session will discuss the details and real-world implications of this new standardized method for communicating and submitting requests for nonbinding FDA feedback, including a Form 483 Observation case study. Our speaker will also provide brief updates on the Medical Device Single Audit Program (MDSAP) and EU Medical Device Regulations (MDR) implementations.



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