Friday 28th February, 2014
9:00am to 6:00pm
Lecture 4: Medical Device Reporting
eMDR Electronic Medical Device Reporting
How to Report a Problem
Event Problem Codes and Manufacturer Evaluation Codes
MedWatch: Safety Information and AER Program
Completing Form FDA 3500A
What form should I use to submit reports of individual adverse events and where do I obtain these forms?
Where and how do I submit reports and additional information?
Does the information in my report constitute an admission that the device caused or contributed to the reportable event?
What are the requirements for developing, maintaining, and implementing written MDR procedures and maintain records/files that apply to me?
Requirements for Individual Adverse Event Reports
User Facility Reporting, Importer Reporting and Manufacturer Reporting Requirements
Lecture 5: Recalls
What happens in a medical device recall: Firm-initiated recall vs. mandatory recall
What information needs to be reported?
What types of records do companies need to keep?
Prior to notifying FDA, what steps should you have taken?
What are the dos and don'ts when informing FDA of a product problem?
Who should be involved in the decision process?
Who should be responsible for communicating with FDA?
What are the consequences of a recall?
What factors should you consider when determining whether or not to get your product back?
How do you prepare for a post recall inspection?
What customer and other outside communications are necessary?
What documentation should be prepared?
How should the product liability implications of recall communications be handled?
What is an effectiveness check?
Health Hazard Evaluations are conducted by FDA
How should you write your recall correspondence?
How do you determine that your recall is completed and what do you do to close your recall internally and with FDA?
Create and use a recall operational
Understand what is required for the recall strategy as expected by FDA
Depth of recall and using a viable, sustainable and effective strategy
Understand why the documentation and paper trail are so critical and termination of a recall
Discuss most recent recalls not only for devices but pharmaceuticals and why the numbers are alarming
Lecture 6: Exercise and Recap of Day 2
Exercise - MDR and Recall
Regulatory Affairs & Compliance Consultant,
David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's. David manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, complaints/investigations, field alerts/recalls) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems.
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