Could Regulatory Science Raise The Bar For Industry?
This article was originally published in The Gray Sheet
FDA is pouring more time and money into the field of regulatory science, and device makers would be wise to wonder: how will this affect us?
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Hamburg touts FDA device review performance in closed-door Minneapolis meet-up last week with senators and industry. Other regulatory news items include a final rule on memoranda of understanding and a new panel meeting scheduled for Hologic’s first-in-class 3D mammography system.
Some advances in medical technology have come with miniaturization, others with non-invasive delivery methods, but some predict the next frontier in advancing device development will be totally virtual.
FDA plans to invest in eight priority areas for regulatory science, including better tools for reviewing innovative technologies and new manufacturing approaches, according to a strategic plan released Aug. 17.