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The FDA finalized guidance on GMP requirements for combination product manufacturers, adding scenarios to clarify how to comply with certain device requirements. Read More
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The FDA issued a draft guidance on the preliminary request for designation process and what information to include.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