FDA 21 CFR Part 806 Medical Device Corrections & Removals
Get expert support for FDA 21 CFR Part 806 corrections and removals obligations, from reportability assessments to defensible documentation and agency-ready submissions. Elexes helps medical device manufacturers evaluate field actions, distinguish routine servicing from reportable events, and manage FDA communications with the precision needed to reduce compliance risk and protect market continuity.
Our FDA 21 CFR Part 806 Services
Targeted support for evaluating, documenting, and managing medical device corrections and removals under FDA requirements.
806 Assessments
Structured evaluations to determine whether a correction or removal is reportable under 21 CFR Part 806, with documented rationale, risk context, and recommended next steps.
Agency Response
Support for responding to FDA inquiries, follow-up questions, and regulatory actions related to field corrections, removals, complaint trends, or post-market compliance concerns.
Change Impact
Regulatory assessment of device, labeling, software, or process changes to determine whether they trigger additional reporting, submission, or post-market obligations.
PMS Governance
Ongoing complaint and post-market surveillance support to ensure field actions, reportability decisions, and safety signals are consistently governed and documented.
RAQA Operations
Embedded regulatory and quality support for manufacturers needing operational help with corrections, removals, complaint handling, documentation control, and FDA-facing workflows.
Compliance Assessments
Gap-based reviews of your documentation, quality system, and post-market processes to identify weaknesses that could affect Part 806 compliance and inspection readiness.
Our 4-Step 806 Support Process
Review the event and scope
We assess the correction or removal event, affected devices, distribution status, complaint history, and risk profile to understand what happened and what regulatory obligations may apply under 21 CFR Part 806.
Determine reportability requirements
Our consultants evaluate whether the action is reportable, exempt, or better handled under another FDA pathway. We document the rationale clearly so your team has a defensible basis for internal and external review.
Prepare records and submissions
If reporting is required, we help assemble the 806 report package, supporting records, timelines, and cross-references to complaint, CAPA, and risk management documentation for a complete regulatory file.
Support follow-up and governance
After submission or internal closure, we help manage FDA questions, strengthen procedures, and align post-market governance so future corrections and removals are handled consistently and audit-ready.
Trusted Regulatory Partner
Success Stories
Supporting manufacturers with defensible post-market decisions, stronger documentation, and smoother regulatory interactions.
“Kudos to the Elexes team! They’re always proactive and have provided invaluable support to us with import, labels, and registrations.”
Philip McFerran
“Having Elexes as our import-export expert was a great choice. Elexes’ team answered all our questions and guided us through every step.”
Linda Pan
“Highly recommend Elexes! They always meet commitments and follow through on action items.”
Joshua Mink
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
“Kudos to the Elexes team! They’re always proactive and have provided invaluable support to us with import, labels, and registrations.”
Philip McFerran
“Having Elexes as our import-export expert was a great choice. Elexes’ team answered all our questions and guided us through every step.”
Linda Pan
“Highly recommend Elexes! They always meet commitments and follow through on action items.”
Joshua Mink
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
“Kudos to the Elexes team! They’re always proactive and have provided invaluable support to us with import, labels, and registrations.”
Philip McFerran
“Having Elexes as our import-export expert was a great choice. Elexes’ team answered all our questions and guided us through every step.”
Linda Pan
“Highly recommend Elexes! They always meet commitments and follow through on action items.”
Joshua Mink
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
The Elexes Difference
Why Choose Elexes?
Manufacturers rely on Elexes for practical, high-stakes regulatory support across the full device lifecycle.
Deep Expertise
50+ years of collective experience across FDA, ISO 13485, EU MDR, and global device regulations.
End-to-End
Support spans due diligence, submissions, post-market governance, and corrections or removals documentation.
Proven Results
250+ successful projects across 200+ product types with a 90% audit clearance rate.
Flexible Support
Engage Elexes as project-based experts or an embedded RAQA operating arm.
Meet The Elexes Team
Experienced regulatory specialists for complex device compliance.
Elexes is a trusted medical device regulatory consulting partner supporting manufacturers through approvals, quality system alignment, and post-market compliance. With 50+ years of collective experience, the team helps companies navigate complex regulatory obligations across FDA, ISO, EU, TGA, Health Canada, and other frameworks. Elexes has become a go-to partner for medical device companies that need more than high-level advice—they need structured execution, defensible documentation, and practical regulatory judgment. From early product development through market authorization and ongoing post-market obligations, the company delivers end-to-end support designed to reduce avoidable delays, strengthen compliance posture, and help manufacturers maintain market access with confidence.
250+ ProjectsSuccessful regulatory and compliance engagements delivered.200+ Product TypesExperience across diverse medical device categories.90% Audit ClearanceStrong inspection and audit readiness outcomes.
Frequently Asked Questions
What is 21 CFR part 806?
21 CFR Part 806 is the FDA regulation that requires medical device manufacturers and importers to maintain records and, in certain cases, submit reports when they initiate a correction or removal of a device to reduce a health risk or remedy a violation that may present a risk to health. It is a key post-market compliance requirement tied to field actions.
What is a 21 CFR 806 report of corrections and removals?
A 21 CFR 806 report is the formal submission made to FDA when a manufacturer or importer undertakes a reportable correction or removal. It typically includes device identification, the reason for the action, dates, quantity affected, distribution details, and an explanation of the health risk or regulatory issue being addressed. Even non-reportable actions still require proper records in many cases.
What is the FDA 806 guidance?
FDA 806 guidance helps manufacturers interpret when a correction or removal must be reported, what records must be maintained, and how to distinguish reportable field actions from routine servicing or stock recovery. It supports consistent decision-making, but companies still need a documented, case-specific regulatory rationale based on the facts, risk profile, and applicable post-market obligations.
When does a correction or removal become reportable to FDA?
A correction or removal becomes reportable when it is initiated to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act caused by the device that may present a risk to health. The decision should be based on documented risk evaluation, device performance issues, complaint data, and the nature of the field action—not just internal business preference.
Are all field actions subject to 21 CFR Part 806 reporting?
No. Some actions may be exempt from reporting, such as routine servicing or certain stock recoveries, depending on the facts and regulatory context. However, exempt does not mean undocumented. Manufacturers still need clear records showing why the action was considered non-reportable, what devices were affected, and how the decision was reached in case FDA reviews the file later.
What records should manufacturers keep for corrections and removals?
Manufacturers should maintain records that identify the device, describe the issue, explain the correction or removal, document dates and quantities, show where affected units were distributed, and capture the rationale for whether the action was reportable. These records should also align with complaint files, CAPA records, risk management documentation, and any related FDA correspondence to support inspection readiness.
How does Part 806 relate to complaints, CAPA, and MDR reporting?
Part 806 does not operate in isolation. A correction or removal often originates from complaint trends, adverse events, nonconformances, or CAPA investigations. In some cases, the same underlying issue may also trigger Medical Device Reporting obligations under 21 CFR Part 803. The key is ensuring your complaint handling, CAPA, risk management, and field action documentation tell one consistent and defensible compliance story.
Can a consultant help reduce risk during an FDA 806 event?
Yes. Experienced regulatory consultants can help assess reportability, prepare the 806 submission if needed, organize supporting records, and align the action with complaint, CAPA, and risk files. This reduces the chance of inconsistent documentation, missed reporting obligations, or weak justifications that could create problems during FDA follow-up, inspections, or broader post-market reviews.
Still Need Help With Part 806?
Talk with regulatory experts about your correction or removal obligations.
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MDSAP
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Software lifecycle compliance capability.
