Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)

On 4 May 2022 the FDA published the final guidance for industry and FDA staff.

FDA is issuing this guidance to provide a policy to help address current manufacturing limitations or supply chain issues due to disruptions caused by the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of HHS on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

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