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FDA has recently increased its efforts to support the development and approval of cell, tissue, and gene therapy (CTGT) products. This is evidenced by the upswing in CTGT approvals in...
"Stay updated on FDA's proposed guidance for orthopedic product coatings. Learn about additional data requirements and potential changes to 510(k) submissions."
EPA Updates TSCA Inventory, Plans Next Update In Summer 2023. EPA announced that latest TSCA Chemical Substance Inventory is now available on its website. TSCA Inventory is list of all existing chemical substances manufactured, processed, or imported in the United States.
Overview The White House, through its Office of Management and Budget (OMB), has issued final Guidance for Regulation of Artificial Intelligence Applications (Guidance) which establishes a framework for federal agencies to assess potential regulatory and non-regulatory approaches to emerging Artificial Intelligence (AI) issues. Consistent with its initial draft guidance, the final Guidance encourages federal agencies to consider ways to both reduce barriers to the development and adoption of AI and address potential regulation of technologies enabled by AI. The Guidance reaffirms this Adminis...
Center for Devices and Radiological Health This guidance provides performance criteria for magnetic resonance (MR) receive-only coils in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for MR receive-only coils will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. Submit Comments