Field actions are a difficult yet necessary aspect of the medical device marketplace. The various stakeholders: regulatory agencies, physicians, users, patients, organizations and personnel are all affected but in different ways, having different requirements to be satisfied. Balancing these different requirements - some documented in regulation, others based on simple human need - creates challenges for those responsible for deciding and implementing field actions. Managing the impact of globalization and the inter-relationships between regulatory agencies, distribution, language, cost consciousness and culture influence the management of actions and determine field action ‘success’... or otherwise.
This course examines compliance with US 21 CFR 803, 806 and 820 regulations, and MDR and the usefulness of the Manufacturer & User Facility Device Experience database (MAUDE). The significance and meaning of the field action classification is explained together with the importance of the field action strategy and plan. The value of knowing the European MDD/AIMD, Japanese rPAL/PMDA, Canadian and Australian requirements and reporting databases such as the MDA and ADR is explained in detail. Additionally, what to communicate to whom allowing for time differences and national requirements, is examined.
Throughout the course examples, case studies and "lessons learned" (including the significance of 3rd parties, product adulteration/misbranding) will help participants appreciate concepts being covered and provide useful insight.
Who Should Attend
This course will be of great value to medical device professionals supporting medical devices in the field – either directly or from ‘home base’. It is primarily designed to benefit the following disciplines and personnel:
- Regulatory and Legal Affairs
- Quality Assurance
- QMS and Compliance Management
- Product Managers
- Sales and Marketing
- Risk Management
- Clinical Affairs
By the end of this course, participants will:
- Understand the regulatory requirements for field actions regarding medical devices
- Understand the difference field action types and classifications
- Understand the applicable standards and guidance documents
- Understand the importance of the relationship with regulatory agencies
- Have worked through evaluation steps and making the field action decision
- Know the required communications and information sharing, and their differences
- Know the similarities and differences between different regulatory agency requirements
- Know the technical and support-documentation needed
- Know the steps to follow and close a field action