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FDA’s CDRA Warns About Cybersecurity
FDA’s Center for Devices and Radiological Health (CDRH) holds a meeting to discuss the risks and threats of cybersecurity in medical devices. They describe the unique challenges involved with security and how difficult...
FDA Updated Guidance on De Novo Requests
The Food and Drugs Administration (FDA), the US authorized body who provides regulation and supervision in the sphere of medical products and devices, finalized a guidance on De Novo applications. De Novo Pathway  De...
FDA Finalized Guidance on HDE Program
The US Food and Drug Administration (FDA) finalized guidance on the Humanitarian Device Exemption (HDE) program on Thursday, reflecting amendments made by the 21st Century Cures Act (Cures Act) and the FDA...
FDA’s Guidance on Placebos
The FDA finalized guidance regarding the use of placebos and blinding during randomized cancer trials. The guidance finalizes a draft made in 2018 and clarifies scenarios where placebo designs and blindings should be...
FDA Shifts from QSR and ISO 13485
  The FDA will shift from QSR to ISO 13485 so that their system regulations can harmonize with international practices to reduce confusion and and lessen the burden for medical device manufacturers.   What is QSR...