The document includes final versions of guidance documents, guidelines for acceptable clinical data from foreign countries, the process for simplifying the recall process and creating a structure for post-market surveillance.
By March 31, the agency hopes to begin the “Innovation Pathway 2.0” pilot
By April 1, the agency hopes to begin a pre-market submissions pilot to increase submission review efficiency and better manage the pre-market review workload.
The agency has also expressed hopes to achieve other goals, including strategies to encourage medical device innovation and improvements to its post-market surveillance program, before the end of the year.
The FDA will also publish a proposal to clarify requirements for clinical studies conducted in foreign countries by Dec. 31.
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