How to Handle Corrections & Removals under 21 CFR 806 2015

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.