Flow chart for deciding when it's appropriate (and required) to recall a medical device under FDA's 21 CFR Part 806 recall rules. This flowchart has been prepared by Gordon B. Richman, Vice President of EduQuest, a global team of FDA compliance experts, who also has more than 20 years of experience as a senior compliance and quality executive in the medial device industry.

1. 21 CFR Part 806 Process Flow
Potential need for
correction or removal
identified
Does the situation involve a
violation of the Federal Food, N Does the situation involve a “risk
Drug, and Cosmetic Act or an FDA to health” under 21 CFR 806.2(j)?
N regulation?
Y
Y
Is the potential action
Under which subpart of
exempt from the reporting Y
21 CFR 806.1(b) is the
requirements under 21
potential action exempt?
CFR 806.1(b)?
N
Document this determination and
identify the specific subpart [21
CFR 806.1(b)(1), (2), (3), or (4)] in
the _____ file
Is the potential action reportable to Evaluate 21 CFR Part 7 (Subparts
FDA under 21 CFR 806.10 – i.e., is it Y A and C) and FDA’s Recall
intended to reduce a “risk to health” Guidance to help define the
[806.10(a)(1)] or to remedy a violation company’s “recall strategy” and
that may present a “risk to health” communications
[806.10(a)(2)]?
End
Prepare a Report of
Correction or Removal
to FDA in accordance
N with 21 CFR 806.10(c)
Prepare a final status
Document the determination that the
update report and request
potential action is not reportable
Submit the Report of Correction for FDA to terminate the
under 21 CFR 806.10 and generate
or Removal to FDA within 10 correction or removal
the records required under 21 CFR
business days of “initiating” the
806.20(b)
action
FDA decision to
Prepare a monthly (unless terminate the
otherwise specified by FDA) correction or
End status update report to FDA removal
The company
receives FDA’s
Submit each status update report formal termination
to the appropriate FDA office letter
End
N Have all of the Y
identified actions
been completed?
© 2012 EduQuest, Inc.