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
Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection As we move further along with this Corona Virus Pandemic situation, with the “world” trying to get their PPE, most importantly, face masks, the quality of the masks is under suspect. To assure that the masks are providing the protection that they claim
FDA Update – COVID-19 – FDA Continues to Combat Fraudulent COVID-19 Medical Products No Surprise here – the FDA needs to make use of their Investigators who are locked in their homes. They are scanning the internet for Fraudulent Advertising concerning the COVID -19. At the end of the first week in May, FDA provided
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
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
Prior to this Coronavirus mess, we had several of our foreign clients scheduled for inspections by the FDA. then everything came to a halt and the FDA investigators were basically on a home lock down. The FDA had always had the authority to request company information under the section 704(a)(4) of the Federal Food, Drug
NO SURPRISE – But a long time coming. Josh Hawley (R., Mo.) announces a new bill “The Medical Supply Chain Security Act” which will help reduce the reliance on Chinese medical supply chain. This is due to the current coronavirus outbreak and addresses potential shortages. The new bill amends “shortage of a drug” to add,
Update on Enforcement Policy for Face Masks & Respirators During the COVID-19 Public Health Emergency This week, the FDA released a guidance outlining their enforcement policy regarding face masks and respirators during the Coronavirus (COVID-19) public health emergency. This includes general use face masks for the general public and particulate filtering face-piece respirators (i.e. N95
The COVID-19 pandemic interrupted many aspects of our lives as we know it. One of the critical concerns on the FDA list is how to handle the ongoing clinical studies during the current pandemic. With that in mind, FDA issued a new document titled “FDA Guidance on Conduct of Clinical Trials of Medical Products During
We have reported previously that US FDA stopped sending their personnel to inspect foreign manufacturers in China due to widespread outbreak of COVID-19. As reported today, the FDA is now postponing most foreign inspections through April, effective immediately. However, inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis. For US-based
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