: 516-482-9001

Category Archives: FDA Updates

Jul

FDA Update: False Positive Results with BD SARS-CoV-2 Reagents

FDA Update – July 8, 2020 False Positive Results with BD SARS-CoV-2 Reagents This will probably not be the last of these types of notices. The FDA is alerting clinical laboratory staff and health care professionals of increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test. In

Jul

FDA Update: The FDA requests your input for the 21st Century Cures Act Report

FDA Update – June 30, 2020 This is an informational notice The FDA requests your input for the 21st Century Cures Act Report On December 13, 2016, the Cures Act was signed into law. This was designed to help accelerate medical product development and bring innovation and advances to patients who need it faster and

Jun

FDA Update – Guidance on Formal Meetings and User Fee Applications

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

10 Jun

FDA Update: FDA Resources

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

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

Archives