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
The warning letters are the first to be issued by the FDA for unapproved products intended to prevent or treat “Novel Coronavirus Disease 2019” (COVID-19). These products are unapproved drugs that pose significant risks to patient health and violate federal law. The FDA is particularly concerned that products that claim to cure, treat or prevent
This week the FDA has issued a final rule banning Electrical Stimulation Devices (ESD’s) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk of injury or illness that cannot be corrected or eliminated through new or updated device labeling. These devices have been associated with an extensive list of serious
This week the commissioner of the FDA released a new update regarding the effects and response of the FDA in relation to the Coronavirus. The FDA has emphasized that they are taking a multi-faceted approach to this public health emergency. This approach includes facilitating efforts to diagnose, treat, and prevent the disease; surveilling the medical
This past week, Costco Wholesale Corporation became the first approved participant in the FSMA Voluntary Qualified Importer Program (VQIP). This program is a voluntary, fee-based program that allows importers to receive expedited review and importation of human and animal foods into the United States under the FSMA. Costco has shown management of safety and security
Many of our clients want to understand what it will take to get a successful launch of your device. Here is some insight to what you should be looking for to assure you give your technology a chance of getting your market to notice. Medical marketing can be a daunting task. For the start-up to
FDA Reclassification Updates Earlier this week, the FDA issued a final order which reclassified several families of medical devices. These devices include certain radiological medical image analyzer such as Computer-Assisted Detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection devices. These devices have been reclassified from
In recent years, reimbursement by insurers has trumped FDA regulatory approval as the medical device industry’s biggest concern and remains at the forefront of stakeholders’ minds. To prevent reimbursement issues from impacting financing goals, device manufacturers must develop a well-planned reimbursement strategy in parallel with their regulatory and clinical strategies in the early phases of
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