Will Heaston's articles Life Sciences FDA Proposes Updates to 510(k) Path On September 6, 2023, the FDA released three draft guidance documents that seek to “modernize” the 510(k) premarket notification process. Ever since the FDA first proposed “transformative new steps” to the program in 2018, the agency has promised to further update the 510(k) clearance pathway in an effort to better balance technological innovation and patient safety. In […] Written by Will Heaston October 19, 2023October 19, 2023 Saving Bookmark this article Bookmarked
Life Sciences FDA Proposes Updates to 510(k) Path On September 6, 2023, the FDA released three draft guidance documents that seek to “modernize” the 510(k) premarket notification process. Ever since the FDA first proposed “transformative new steps” to the program in 2018, the agency has promised to further update the 510(k) clearance pathway in an effort to better balance technological innovation and patient safety. In […] Written by Will Heaston October 19, 2023October 19, 2023 Saving Bookmark this article Bookmarked
