HHS proposal to exempt medical devices from 510(k) process halted
By EsqSocial Corporation 22/01/21
On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the normal regulatory process was temporarily waived during the COVID-19 public health emergency – from the Food and Drug Administration (FDA) 510(k) notification requirement....
By: Hogan Lovells