The guidance defines remanufacturing, includes relevant considerations to determine if activities are remanufacturing, and provides recommended labeling information to ensure serviced devices are returned to their established performance and safety specification.
“With this strategic alliance we are strengthening our worldwide presence and can serve the needs of our customers anywhere. With teams of seasoned consultants both MEDIcept and Pure Global offer deep expertise across a wide range of compliance needs.”
“The final rule announced today aims to provide crucial oversight of these tests to help ensure that important healthcare decisions are made based on test results that patients and health care providers can trust.”
Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s specific requirements. An appreciation of the unique considerations for artificial intelligence-enabled technologies is another essential component of an efficient and effective application.
Embracing certification leads to enhanced product quality, innovation, and customer trust.
Regulatory excellence is now considered a pathway to innovation and sustained business growth, making it a fundamental component of success in the medical devices industry. MedTech manufacturers are fostering a culture of regulatory excellence to enhance compliance with regulatory requirements and ensure product safety, efficacy, and quality in the global marketplace.
The FDA is hosting it next town hall on medical device sterilization on April 29. The session will include discussion on topics and formats for future sessions in the series.
The consent decree restricts the production and sale of new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines and other devices at several Philips Respironics facilities in the U.S. until certain requirements are met.
On April 17, the FDA is hosting a Virtual Public Workshop on approaches to Accreditation Scheme for Conformity Assessment Expansion.
The Investigational New Drug (IND) application and the New Drug Application (NDA) stages are critical milestones in drug development, but they are different applications. Developers and sponsors must understand which application requires which data and when. Here we highlight strategies, hurdles and data required for successful drug development from IND to NDA.
