FDA is concerned that the distribution of unapproved and uncleared IVD products labeled RUO or IUO, but intended for purposes other than research or investigation (for example, for clinical diagnostic use), has led, in some cases, to the clinical diagnostic use of products with unproven performance characteristics, and with manufacturing controls that are inadequate to ensure consistent manufacturing of the finished product.
Use of such tests for clinical diagnostic purposes may mislead healthcare providers and cause serious adverse health consequences to patients, who are not aware that they are being diagnosed with or treated based on the results of tests with research or investigational products. The industry contends that the proposed changes would instead lead to regulations that disrupt the operations of clinical molecular labs. FDA worries about the process of distribution of uncleared and unapproved IVD products also labeled as RUO/IUO.
This session by international risk management, patient safety and quality assurance consultant Dev Raheja, MS, CSP, will cover areas such as patient care concerns, protection of patients from unauthorized use of RUO and IUO products, and protecting your executive from legal liability. The webinar will also assist you in conforming to FDA requirements for marketing RUO and IUO products, learn about the negative consequences of the regulations, and weighing the risks and benefits.
Plus, you’ll get:
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance/Manager of Manufacturing Engineering, at Cooper Industries as Chief Engineer, and at Booz-Allen & Hamilton...
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