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 than just 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 can also 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 email@example.com.
1FDA (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