The FDA's Center for Devices and Radiological Health released its strategic priorities for 2012 which focus on four areas: implementing a review process that looks at the entire product life cycle, enhancing communication and transparency, strengthening its workforce and proactively aiding innovation.
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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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.
Related Articles on the FDA:
FDA Approves Genzyme Framingham Manufacturing Plant
FDA Clears Medtronic's Aquamantys SBS 5.0 Sheathed Bipolar Sealer for Spine Surgery
FDA Approves Carl Zeiss Meditec's Cirrus HD-OCT for Dry AMD and Glaucoma