How to Handle Corrections & Removals under 21 CFR 806

Overview:
As an experienced FDA medical device investigator, at one time or another many firms I’ve inspected have struggled with deciphering the definitions of the FDA regulations and misinterpret the definitions provided in §806.1 (a) (b)(1)(2)(3) that deal with exemptions are the most widely confused in interpretation and manufacturers and importers misinterpret reportability and documentation requirements required by § 806.10. Even if the firm does file a recall report within the specific timeframes, many times the firm fails to properly classify the recall.

When determining if a corrective action, market withdrawal or field service taken to a medical device in response to a design change or corrective action, the manufacturer must be sure to fully review the exemption requirements under §806.20 (j)- "Risk to health". Risk to health has two definitions, the first easily interpreted when there is a reasonable probability that the use or exposure of a medical device could cause serious adverse health consequences or death. Part 2 is confusing in that the definition states that a risk to health can be considered a temporary or medically reversible adverse health consequence or the possibility of serious adverse health consequences are remote.

Many manufacturers fail to properly classify their correction and removal based on severity. It is usually better to err on the side of caution and report the correction and removal; but in all cases, properly document the firm’s rationale for reporting or not reporting. Each year, the FDA emphasizes the need for investigators to determine that each firm under the FDA area of jurisdiction properly maintains "Recall SOPs", trains these procedures and fully implements them.

Why should you Attend: Many medical device firm struggle with the rationale as to when they must report a recall to FDA and often fail to identify when a correction is made that in fact they had just conducted a recall. There are specific definitions in 21 CFR 806 which outline the various types of corrections and removals. Each type has its own requirement for reporting and requirements if the company determines not to report the correction to FDA.

This webinar will assist the viewer as to when a recall should be reported to FDA and how to handle it when no notification is required.

Areas Covered in the Session:

What is a recall
What is a Market Withdrawal
When to report to FDA
How to report to FDA
What can happen when you fail to report a recall

Who Will Benefit:
All Medical Device manufacturers
Medical Device Investigator
Risk Management Specialists
QA Managers
Regulatory/Legislative Affairs Professionals
R&D and engineering staff

Speaker Profile

Leo Lagrotte Currently serves as a Senior Regulatory Consultant for Quality Solutions & Support, LLC, a consulting practice offering auditing, training and advising to small, medium and large Medical Device and Radiation Emitting Device manufacturers as a follow-up to 20 plus years’ experience with the FDA and USDA. Mr. Lagrotte’s previous regulatory service was preceded by military service as a commissioned Officer in the US Army, and twenty plus years as a civilian owner/operator of retail food establishments including bakeries, restaurants and catering.

Contact Information:
Compliance4All
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
Phone:800-447-9407
Fax: 302-288-6884
[email protected]
http://www.compliance4all.com
Event Link - http://bit.ly/1vJc0a0