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What are the requirements for manufacturers and producers of in vitro diagnostic products?
Date:2023-02-08
1. Manufacturers and producers of in vitro diagnostic products must comply with the quality system requirements under the ISO 13485:2003 standard. These requirements include establishing a quality management system, validating processes, and conducting follow-up activities to monitor and improve the quality system over time.
2. Manufacturers and producers need to obtain a valid European Conformity (CE) mark recognition which evidences conformity with the EU's In Vitro Diagnostic Medical Devices Directive 98/79/EC.
3. Manufacturers and producers must also adhere to the regulations implemented by the U.S. Food and Drug Administration (FDA). Regulations vary depending on the type of in vitro diagnostic device including; (1) Premarket Notification (510k) submissions (for Class II devices) or Premarket Approval (PMA) (for Class III devices); (2) Good Manufacturing Practices and Quality System Regulations; (3) Labeling and Advertising; and (4) Postmarket Surveillance and Reporting.
4. Manufacturers and producers need to conduct clinical trials to evaluate the safety and performance of a device and to compile data to support the device's intended use.
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