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
FDA Update – June 30, 2020 FDA Issues Guidance Regarding Compliance Dates for Unique Device Identification Requirements On June 30, 2020, the FDA issued the guidance Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking for immediate effect. The unique device identification (UDI) system is
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
COVID-19 – FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk This information is not surprising. During the times of consumer and govt panic, there will always be companies trying to take advantage of situation. The FDA tries their best to keep on top of the situation to
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
mdi Consultants, Inc