If you are in the medical device industry, chances are you’ve heard of Remediation. But what exactly is it? Is it going back and just simply fixing non-compliances, is it a response to regulatory enforcement actions? The short answer is it is a customized solution to a firm’s compliance issues. Whether you caught non-compliances internally or had a less-than-perfect regulatory inspection, Remediation should be looked at as the process of creating a plan to correct and prevent non-compliances and executing that plan...

1. What is Remediation?
By: Madison Wheeler
If you are in the medical device industry, chances are you’ve heard of Remediation. But what
exactly is it? Is it going back and just simply fixing non-compliances, is it a response to
regulatory enforcement actions? The short answer is it is a customized solution to a firm’s
compliance issues. Whether you caught non-compliances internally or had a less-than-perfect
regulatory inspection, Remediation should be looked at as the process of creating a plan to
correct and prevent non-compliances and executing that plan.
If you are thinking that sounds an awful lot like the CAPA process, you would be correct. Often,
Remediation efforts can be captured in a grouping of CAPA’s to govern the activities as they
unfold. Something to note, however, is that Remediation is a much larger task thanjust opening
CAPA’s. It is an all-encompassing plan to ensure that a medical device firm and its products on
the market are compliant, safe, and effective.
If you receive a Form 483 or Warning Letter as the result of a regulatory inspection, you have 15
days to respond or face further enforcement action.1 This is not something you want to take
lightly; it is critical that you respond to any FDA findings as thoroughly and efficiently as
possible. This is where Remediation truly is beneficial because it shows the agency that you are
committing to the planning and implementation of whatever is necessary to fix your
noncompliance(s).
Remediation can also be leveraged even if you have not received FDA enforcement action yet. If
major issues are identified through a gap assessment or internal audit, a Remediation plan can
be implemented to govern the corrective actions necessary to bring you into compliance.
Although it is not a “get out of jail free card”, it can also be used to show a potential FDA
inspector that you have already identified the issues and are working towards a solution.
Remediation efforts are a huge undertaking, requiring a lot of resources, time, and effort. Of all
the Remediation projects I have been a part of, the common factor for all successful ones is the
100% commitment to getting it done, and getting it done right. Firms that do not take
Remediation seriously typically face bigger issues down the line with the FDA. Having experts in
your corner tackling Remediation efforts canalso help. EMMA International has helped
countless clients through Remediation with everything from communicating with the FDA,
creating a custom Remediation plan, and working alongside teams to implement corrective
actions. If you need assistance with FDA enforcement actions, or just need another set of eyes to
ensure your organization is compliant, contact EMMA International at 248-987-4497 or email
us at info@emmainternational.com.
1 FDA (Jan 2020) Form 483 Frequently Asked Questions retrieved on 02/21/2020 from:
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-
form-483-frequently-asked-questions