To embed, copy and paste the code into your website or blog: On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their January 15 proposal to exempt 84 medical device types – for which the normal regulatory process was temporarily waived or made more lenient during the COVID-19 public health emergency – from FDA’s 510(k) notification requirement. In its notice, FDA cited a “flawed” reliance by HHS, which issued the original notice, on FDA's Manufacturer and User Facility Device Experience (MAUDE) database for adverse event reporting. However, this withdrawal does not override the January 15 exemptions for seven class I medical devices, all of which were gloves.