COVID-19 – Guidance on Formal Meetings and User Fee Applications Due to the COVID-19 public health emergency, the FDA has released a new guidance document titled “Effects of the COIVD-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices – Questions and Answers.” The reason for this guidance is to address
In inquiring with the FDA, they made many of their resources available through links they provided. Links for an overviews of the FDA’s activities regarding medical devices can be found on their website. Information related to device advice, medical device safety as well as other resources are available throughout this page. Additionally, the FDA made
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
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
On May 11, 2020 the FDA released a press announcement to address new actions to help accelerate the development of prevention and treatment options for COVID-19. The FDA has provided new guidance with recommendations for innovators and researchers. These guidance documents aim to make the process of submitting applications in initiate studies for new drugs
WELL no surprise – this COVID-19 Mask situation is very fluid and the FDA has made another update on what they are allowing to be labeled as a FFR Mask that are not NIOSH approved. The USA is being the WILD WILD WEST when it is related to the FACE MASK marketing. Not surprising –
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
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
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
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