FDA: Class III devices will require a PMA

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Manufacturers of all Class III devices soon could be required to either go through the pre-market approval (PMA) process or reclassify their devices, according to the FDA.

FDA News
reported that the agency’s decision is in response to a Government Accountability Office (GAO) report released last week, which recommends that the FDA “expeditiously take steps” to require all Class III devices to obtain a PMA or be reclassified.

The GAO report sad that the FDA had cleared more than 200 high-risk Class III devices, and go through a less stringent review process that was intended for simpler products.