Two days workshop on
Postmarket Compliance for Medical Devices and Evolving Reporting Requirements: Complaint Handling, MDR/eMDR, Recalls and UDI Update
Coming soon.. Please contact customer care for new schedule at +1-510-857-5896
Course Description
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized along with an overview of best practices for timely and effective investigations. Trending is the only way a company can stay on top of emerging quality issues and address those that are most pressing.

Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.

The MDR process impacts device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified follow-up.

Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III.

Unique Device Identification implementation planning is critical for medical device companies. Analyzing, strategizing and planning are essential to determining if you will successfully implement UDI and the related GUDID submission. You need to have a full understanding of your devices, labeling/manufacturing locations and packaging requirements. Study the UDI Regulation to comprehend which aspects you will need to comply with as you develop your plan.

A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device (lot, serial number or expiration date).

Another component of the UDI system is an FDA-controlled database that will include a standard set of identifying elements for each UDI. Most of this information will be publicly available so that users of a medical device can easily look up information. Make sure you comply with FDA's UDI compliance dates and what steps need to be taken.

Course Objectives
  • Understand that although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any system
  • Grasp and comprehend the definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls
  • All personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of complaints
  • Provide information about FDA's Medical Device Reporting (MDR) regulation and the Voluntary Reporting program called MedWatch
  • Introduce you to Medical Device Reporting and to help you better understand the process and benefits of Voluntary Reporting and responsibilities
  • Latest Amendments to the MDR Regulation to Implement FDAMA Changes
  • To Recall or Not to Recall: Issues to consider regarding whether a Field Action is required
  • Determine when a recall is required and how to manage a recall, who must report, when to report, what to report, where to report, recordkeeping requirements, FDA regulatory authority, references and guidance
  • Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
  • Review and discuss pain points, challenges and solutions
  • Introduction to UDI and History
  • Final Rule: UDI regulation
  • Upcoming FDA UDI compliance deadlines for device manufacturers
Areas Covered
  • Reporting complaints
  • Complaint evaluation and investigation and effective root cause analysis
  • Data collection and trending
  • CAPA process for investigating complaints
  • Accelerate complaints recording, investigation, reporting, escalation/triggers and closure cycle as cases are automatically routed from one stage to the next
  • Gain enterprise-wide visibility into the complaints data and track the process with performance metrics, dashboards or other indicators
  • Improve communication and teamwork on complaints across departments and functional areas
  • Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process
  • Improve management of the complaint lifecycle with real-time trending and escalation of customer complaints
  • Understand the History of MDR Regulation
  • What types of Reports does the FDA receive and who must submit Mandatory Reports to the FDA?
  • Who can submit Voluntary Reports to the FDA?
  • How to submit e-MDR reports and ensure timely reporting requirements are met for MedWatch 3500A
  • How Does the FDA Use Medical Device Reports?
  • What are the exemptions, variances, or alternative forms of adverse event reporting requirements?
  • Basics of a Recall: Initiation, Classification and Public Warning
  • Medical Device Recall Reporting and Classification Levels
  • Recall Responsibilities & Requirements
  • FDA's Role
  • Introduction to Medical Device Recalls: Industry Responsibilities
  • Recall Communication and Strategy
  • Monitoring and Auditing Recall Effectiveness
  • Recall Termination
  • Guidance for Industry, Trends and FDA Inspection & Enforcement Statistics and Trends
  • UDI is a unique numeric or alphanumeric code that consists of two parts: DI and PI
  • How GS1 Standards can be used to meet UDI requirements
  • Tools and resources, including guidance, available to help you get started with UDI
  • Gain an understanding of UDI in practical terms
  • Walk through the planned timeline for proposed FDA UDI regulations
  • Compliance dates and expectations for UDI requirements affecting all classifications of devices
  • Evaluate the benefits of implementing bar-coding using GS1 standards
  • Understand how labeling systems can remove the perceived complexities of FDA's UDI regulations
  • Direct Marking of Devices
  • Convenience Kits and FDA's position for meeting UDI requirements
  • Data submission requirements
Who will Benefit
This seminar will provide an overview and in-depth snapshot of the process for managing your product complaint/complaint handling program, Medical Device Reporting program and addressing and facilitating Recalls. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the complaint handling, MDR and recall process from start to finish, including:
  • Regulatory Affairs Management
  • Regulatory Affairs Specialist
  • Auditors
  • Compliance Officer
  • Compliance Specialist
  • Clinical Affairs
  • Quality Assurance Management
  • Marketing & Sales
  • Distributors/Authorized Representatives
  • Legal Counsel
  • Engineering/Technical Services
  • Operations/Manufacturing
  • Consultants
Topic Background
Complaint handling systems have come under intense scrutiny by the FDA in recent years and enforcement trends confirm this as of recent. The seminar will examine the current industry and FDA environment and provide you with the knowledge and tools for survival as well as making existing complaint handling systems more robust, easier to manage and enforce. It will provide a step-by-step guide for establishing, deploying, managing and auditing your Complaint Handling System for today's medical device industry environment. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an on-going analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations.

Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. Manufacturers, User Facilities, and Importers are required to submit certain adverse events to FDA. Health professionals and consumers may submit reports of device adverse events or product problems to FDA via the MedWatch program in one of several ways. This seminar will provide the snapshot of the of the MDR regulation, why you have to report, how and where to report, introduce you to the forms and provide step-by-step instructions as to your responsibilities. Medical device recalls are usually conducted voluntarily by the manufacturer. In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer and the seminar will describe the procedures the FDA will follow in exercising its medical device recall authority, as well as introduce the audience to the recall classification process, recall strategy, recall status reports, termination of a recall, effectiveness checks, company's recall procedure, among other key areas.

The Unique Device Identification system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this final rule and regulation. Understand the significance of UDI, GS1 standards, and the GTIN (Global Trade Item Number) which are already recognized across the healthcare industry as a unique identifier of medical devices, surgical products and healthcare supplies. The GS1 GTIN used for device identification, along with Production Information (PI) supports the FDA UDI regulation. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception from some or all of the requirements of the final rule. The UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture technology. Device labelers must submit information concerning each device labeled with a UDI to FDA's Global Unique Device Identification Database (GUDID). The UDI is required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. Medical device records throughout the required device recordkeeping and reporting systems will have to include the UDI. In addition, the final rule establishes accreditation requirements for organizations that issue UDIs and establishes the conditions for when FDA might act as an issuing agency. Depending on the risk of the device, labelers will have from 1 to 7 years to comply with the UDI system.

Target Audience
  • Class I, II and III medical device manufacturers/In Vitro Diagnostics manufacturers
  • Contract medical device manufacturers
  • Contract sterilizers
  • Repackagers, relabelers, specification developers, reprocessors of single-use devices
  • Manufacturers of accessories and components sold directly to the end user
  • U.S. manufacturers of "export only" devices
  • Pharmaceutical manufacturers
  • Distributors
  • Importers
  • User Facilities (e.g., hospitals, nursing homes)

Day 1 (8:30 am - 9:00 am: Registration Process)

Complaint Handling
  • What are the elements of an effective complaint management system?
  • How does risk management influence complaint handling decisions?
  • What are the responsibilities of other departments?
  • What is the best way to train customer contact employees?
  • What steps would the FDA expect to see the departments taking that sorts out potential MDRs, product complaints and other reportable events?
  • What and how do you perform trending?
  • What are examples of how companies trend and analyze service calls and product complaints?
  • Understand how and why CAPA is tied in to product complaint investigation
  • What is an appropriate complaint handling system in a risk-based post-market environment?
  • How do you audit a complaint handling system?
  • From your audits, how do you judge that your complaint handling system is effective?
  • Assignment of responsibility
  • Manufacturer should develop a method for maintaining records of complaints and investigations that: is functional and economical, meets company needs, and meets FDA requirements and expectations
  • Identify designated complaint handling unit
  • Instructions for documenting complaint information
  • Process for evaluating complaints
  • Process for investigating complaints
  • Identify and process MDR's
  • How to process customer returns
  • Records and trend analysis
  • Complaint closure
  • Examples of tools currently being used to conduct investigations
  • How far and in-depth do you go with your investigations
  • What are current FDA 'hot' buttons and trends, benchmarks and best practices for investigations
  • How to become a 'good' investigator and the emphasis on closed-loop investigations
  • Written Procedures: Designated Complaint Handling Unit, Training and Records
  • Recent Enforcement Actions
Medical Device Reporting
  • Introduction to Medical Device Reporting
  • What are the key terms, definitions and forms?
  • MDR procedures and processes
  • What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
  • How do you manage international reporting requirements under your complaint handling system?
  • Consider the relationship between MDRs and Risk Assessments
  • Meeting reporting requirements for FDA
  • Recent enforcement actions
Exercise and Recap of Day 1
  • Exercise on Product Complaints/Complaint Handling
  • Quiz
Day 2 (8:30 am: Workshop start)

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
  • Recent enforcement actions
  • 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 and why effectiveness verification checks are important
  • 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
  • Latest FDA statistics and trends with recent recalls
Unique Device Identification
  • Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalog for every device with an identifier
  • GUDID provides two options for submission of device identification information
  • Learn how to implement UDI with minimal impact on your organization
  • Impacts on labelers and establishments and meeting FDA's compliance deadlines
  • Device Identifiers vs. Production Identifiers: What goes into each one?
  • Frequently Asked Questions and Next Steps
  • The Unique Device Identifier (UDI) (FDA, Sept. 24, 2013) is intended to track a medical device through its entire lifecycle
  • Most of the healthcare industry saw UDI as a labeling and supply chain regulation; it has now become apparent that it will be used throughout the continuum of care due to its adoption in electronic health records (EHRs) and claims payment systems
  • Medical Device Reports (MDRs) on adverse events require that the UDI be reported; once a signal has been identified by FDA, the manufacturer/labeler will be contacted to gather production identification (PI) information, so that warnings and recalls can be targeted more directly by lot or batch
  • UDI is not a "one and done" project; the entire system will need continual maintenance
  • Computer systems will need constant updating, as changes to devices or new ones are developed; you will need to appoint someone with clear responsibility for maintaining your information in GUDID
  • Post-market surveillance activities also feed into the post implementation process, as device changes are made as a result of tracking and reporting activities; and you will find that you will continually need to train your staff on UDI requirements
Debrief / Adjourn
  • Recap of topics and key discussion points and take away message
  • FAQs and latest trends

David R Dills - Regulatory Affairs & Compliance Consultant

David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.