A recording of the webinar is available.
Please mark your calendars to join us for this special webinar aimed at addressing a number of key issues related to the US Food & Drug Administration’s (FDA) refocused concerns on medical device adverse event reporting.
As background, the FDA’s focus here centers on leveraging real-world data on medical devices, leading to the agency’s inspecting and issuing Form 483s to 14 hospitals around the country citing violations of FDA laws and regulations for inadequately reporting medical device adverse events. An FDA Form 483 is issued to management at the conclusion of an inspection when investigators observe any conditions that, in their judgement, may constitute violations of the Food Drug and Cosmetic Act and related acts.
While not usually public information, the FDA published each hospital’s Form 483 via a post on its blog last month. Having never enforced these regulations before, the FDA will hold a public workshop with interested stakeholders to discuss ways that it and hospitals can work together for better transparency of medical devices as they are used in the real world. We recently issued some additional details on this action with a client alert, “FDA Working to Enforce Medical Device Adverse Event Reporting in Hospitals".
We hope you can join us for this informative webinar, with a focus on helping industry practitioners, particularly those in compliance and risk management, better understand the implications of this action, including:
- User facility or hospital adverse event reporting requirements
- Who must report and how
- The FDA’s current adverse event reporting programs
- Highlights from the FDA’s December workshop
Shortly after registering, you will receive a confirmation email containing the log-in details to use on the day of the webinar.