Description
This quarterly newsletter includes:
Executive Summary
Device – Citation Total & Category Breakdown
Device – Quarterly Breakdown
Device – Total Quarterly Citations
Device – Category Total
Device – Packaging/Clinical Totals
Device – Packaging/Clinical Quarterly Trend
Device – Top 8 Subsystems & Quarterly Breakdown
Device – Quarterly Breakdown
Device –Records Subsystem & Production Controls
Device – Production Controls
Device – Total Citations
Device – Subparts G, H & Clinical Activity
Device – Clinical Activity, Quality Requirements, Design Control, CAPA
Device – cGMP Systems Definitions
CFR Title 21 Parts 1 to 1499
CFR Title 21 Part 820
CFR Title 21 Part 803
Medical Device Single Audit Program Links
Device – Warning Letters
The publication also provides over 12 charts and graphs providing clear graphical data highlighting current regulatory trends for medical devices. An executive summary provides a synopsis of all data presented in the newsletter and significant changes in regulatory trends. Current Good Manufacturing Practices, Packaging and Clinical categories are successively drilled down to identify the top 8 citations for devices. Key medical device regulatory subparts are identified through charts and graphs. Active links to all warning letters for the time period reported are provided as well as links to FDA regulations for easy reference without the need to navigate the FDA website. Among the many uses, newsletters are used to objectively evaluate risk, prioritize audit observations and corrective actions, prepare for internal audits and as training tools in addition to defining regulatory.
