We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
For products that include a device component, sponsors must submit five-day reports, with supplemental or follow-up reports; malfunction reports; and correction or removal reports, as well as comply with recordkeeping requirements. Read More
Manufacturing-related provisions in the recently enacted 21st Century Cures Act establish a program for “breakthough” devices, exempt some categories of medical software from regulation as a medical device, and require the FDA to publish a list of reusable device types that must include usage instructions and cleaning data. Read More
The FDA issued a draft guidance on the preliminary request for designation process and what information to include. The pre-RFD process provides feedback on the regulatory identity or classification of a drug, biologic, or combination product, which could include a medical device. Read More
The Swiss Agency for Therapeutic Products (Swissmedic) announced that it will allow orphaned manufacturers whose Notified Bodies have ceased operation to continue marketing their devices, subject to certain conditions. Read More
The FDA has released final guidance on assessing the risks and benefits of investigational device exemption (IDE) applications for human clinical studies. Read More
The Mozambique Drug Authority is pushing the Ministry of Health and Family Welfare in India to improve the quality of drugs manufactured in India. Read More