|Quantity Discounts||1 - 2|
|3 - 4|
|5 - 6|
|6 - 9|
|10 - 99|
Damned if you do, damned if you don’t. That’s the feeling many have in trying to comply with recalls related to 21 CFR Part 7 and 21 CFR Part 806.
Under 21 CFR Part 7, you are requested to report corrections or removals to your FDA District Recall Coordinator promptly. But under 21 CFR Part 806, you are required to report within 10 business days after initiating such corrections or removals.
Not only are devicemakers running afoul of the FDA on this point, they're likely to under-report field actions by misinterpreting Part 806.
When is reporting voluntary vs. mandatory? What characteristics of the recall must you consider when making that determination? When there is a conflict, which rule applies? Discover the answers — and more — in this management report from FDAnews.
This report outlines four easy-to-follow steps to determine which regulation applies ... or when neither applies and no reporting is necessary. You’ll learn:
Part 806 gets particular attention in this report. Many devicemakers are not clear on how Part 806 aligns with general recall requirements under Part 7, as well as standing recall guidance. Getting this wrong can lead to under-reporting device recalls ... and an unwelcome slap on the wrist.
Don’t risk that in your operation — not when a simple four-step procedure can make this problem go away for good. Order your copies of Medical Device Recall Reporting: Four Steps to Compliance with 21 CFR Parts 7 and 806 ... now.
Get Multi-user Access With The Electronic Books Library.
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.
Need Extra Print Copies?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Simply choose the quantity you wish to order the discount will be calculated automatically.
3-4 copies – 10%
5-6 copies – 15%
7-9 copies – 20%
10+ copies – 25%
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 – Fax (703) 538-7676 – Toll free (888) 838-5578.
Copyright ©2014. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing