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Category Archives: FDA Updates

09 Jun

FDA Update: COVID-19: FDA Reissues Emergency Use Authorizations Revising Which Types of Respirators Can Be Decontaminated for Reuse

FDA Update: COVID-19: FDA Reissues Emergency Use Authorizations Revising Which Types of Respirators Can Be Decontaminated for Reuse Recently the FDA released news that they are reissuing EUAs revising which types of respirators that can be decontaminated for reuse. Based on the FDA’s further understanding of the performance and design of certain respirators, they have

27 May

FDA Update: Supplements for Approved Premarket Approval (PMA)

Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency The FDA released a new guidance document on May 21, 2020 addressing manufacturing limitations or supply chain issues due to disruptions being caused by the COVID-19 public health emergency. This policy applies to limited

05 May

FDA Update: COVID-19 TEST

Policy for Coronavirus Disease-2019 Tests During Public Health Emergency In the first week of May, the FDA released a new guidance document: “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).” This new policy supersedes the guidance document issued during the second week of March. This new guidance document highlights policies for accelerating

01 May

FDA Update: COVID-19

ALCOHOL-BASED HAND SANITIZERS Due to COVID-19 pandemic, the FDA released an announcement on April 27, 2020 about the availability of alcohol-based hand sanitizer. The FDA wants to address safety concerns related to products being sold that are not in line with the FDA’s policy and others being marketed with unproven claims. Due to the increased

28 Apr

FDA Update – COVID-19

RE: Update on Enforcement Policy for Face Masks & Respirators During the COVID-19 Public Health Emergency During the first week of April, the FDA released a guidance document outlining the up-to-date policy regarding face masks and respirators during the Coronavirus (COVID-19) public health emergency. The reason for this guidance is to help expand the availability

26 Apr

SFDA (Chinese Government) update

April 26, 2020 – NEW REQUIREMENTS for the export of MASKS made in China – the Chinese Government now requires that all companies looking to export PPE device have a declaration by both the Foreign Exporting company and the importer (the USA company) certifying that are in agreement that quality standards. (see attachment 1) Attachment

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