HHS withdraws proposal to exempt 84 medical device types from FDA 510(k) process | Hogan Lovells
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 (MAU...