$297 — Premium Tier

Medical Device Recalls & Field Safety Toolkit: FDA 21 CFR Part 7 + EU MDR

Medical Device Recalls and FSCA Toolkit — recall strategy guide, notification letter templates, effectiveness check protocol, EU FSCA notice, RCA template, and recall termination report.

Get the Toolkit — $297

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What's Included

Recall Strategy and Classification Guide (FDA 21 CFR Part 7)
Recall Notification Letter Templates (Consignee and Customer)
FDA Recall Effectiveness Check Protocol
Field Safety Corrective Action Notice Template (EU MDR)
Root Cause Analysis and CAPA Template for Recall Events
Recall Close-Out Report and Termination Request Template

Benefits

Dual-jurisdiction coverage: FDA 21 CFR Part 7 and EU MDR Article 87
Effectiveness check protocol covers Level A-D determination and documentation FDA requires for termination
FSCA notice template aligned with MEDDEV 2.12/1 Rev 8 and EUDAMED reporting workflow
Recall termination request package structured to minimize FDA back-and-forth

Is This For You?

This toolkit is designed for teams facing these challenges:

No documented recall strategy before an event forces reactive decision-making
Effectiveness check levels not determined systematically
FDA delaying recall termination due to inadequate effectiveness check documentation
EU FSCA obligations not addressed in recall plan

Who This Is For

VP Regulatory Affairs managing recall responseQA directors overseeing post-market safetyOperations leaders responsible for product retrievalRA consultants supporting clients through FDA recall process

Frequently Asked Questions

What is the difference between a recall and a market withdrawal?

A recall involves a product with a violation of FDA law that may present a risk to health. A market withdrawal involves a minor violation or no violation at all. The recall strategy guide includes the decision framework.

How quickly must we notify FDA of a recall?

For Class I recalls, FDA must be notified within 10 working days of initiating the recall. The guide covers all notification timelines by recall class.

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Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $297

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