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Validation of Next Generation Sequencing | In Vitro Diagnostics (IVDs)

Guidance for Stakeholders and Food and Drug Administration Staff Document issued on April 13, 2018. The field of genomic testing is dynamic, building off of increasing amounts of data and a rapidly evolving technology base. Next-Generation Sequencing offers multiple approaches for the investigation of the human genome, including sequencing of the whole genome, exome, and transcriptome. […]

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Health Canada Published Draft Guidance on Premarket Device Cybersecurity

Health Canada’s Approach to Digital Health Technologies

HealthCanada is establishing a new division within the Therapeutic Products Directorate’s Medical Devices Bureau to allow for a more targeted premarket review of digital health technologies, to adapt to rapidly changing digital health technologies, and to respond to fast innovation cycles. Digital health technologies can include stand-alone software applications as well as integrated hardware and software systems which

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FDA 510(k) Premarket Notification for your medical device Ultrasonic Diathermy Devices

510k Premarket Notification | Ultrasonic Diathermy Devices

Guidance for Industry, Food and Drug Administration Staff. Document issued on April 16, 2018. What is an Ultrasonic Diathermy Device? Ultrasonic diathermy devices are the medical devices that are used in physical therapy equipment that produce high-frequency sound waves where this movement is found into tissue and create gentle restorative heat. Ultrasonic diathermy devices are

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