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Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
FDA Provides Guidance on Production of Alcohol-Based Hand Sanitizer to Help Boost Supply, Protect the Public
FDA notes these guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.
2020 COVID-19 Update: FDA Continues to Facilitate Development of Treatments
The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary.
New FDA Guidance and Labeling Changes Affecting PneumoLiner, the Only 510(k)-Cleared Containment Device Reports Olympus
The updated guidance from the Food and Drug Administration mandates that laparoscopic power morcellation in gynecological procedures be conducted with an approved containment device. When taken together with the updated labeling for 510(k) of the PneumoLiner, and an FDA safety update entitled "The FDA recommends performing contained morcellation in women when laparoscopic morcellation is appropriate," the agency is now offering a cohesive and succinct guidance for future use of laparoscopic power morcellation. PneumoLiner, made by Advanced Surgical Concepts (ASC) and exclusively distributed by Olympus, remains the only containment device 510(k)-cleared for use during power morcellation.
COVID-19 Update: FDA Gives Flexibility to NYS Department of Health, FDA issues Emergency Use Authorization Diagnostic Testing
Yesterday, the U.S. Food and Drug Administration took two significant actions in the agency's ongoing and aggressive commitment to address the coronavirus outbreak COVID19.
TransEnterix Receives FDA Clearance for First Machine Vision System in Robotic Surgery
This Intelligent Surgical Unit is compatible with both the global installed base of Senhance Surgical Systems and with third-party vision systems that are currently supported by Senhance advises TransEnterix.
COVID-19 FDA Update: Foreign Inspections
FDA provided an update on the status of FDA inspections outside of the U.S. in response to the COVID-19 outbreak. After careful consideration, the FDA is postponing most foreign inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.
FDA Proposes Broad Approach for Conducting Safety Trials for Type 2 Diabetes Medications
The FDA notes the new draft guidance does not contain the recommendation that sponsors of all new therapies for type 2 diabetes uniformly rule out a specific degree of risk for ischemic cardiovascular adverse outcomes, which was recommended in previous guidance and has typically been done through cardiovascular outcome trials.
Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19
These products are unapproved drugs that pose significant risks to patient health and violate federal law.
NeuroPace RNS System Receives FDA Approval for MRI Labeling, Allowing Thousands More Patients to Benefit from Personalized, Data-Driven Epilepsy Treatment
Individuals with focal onset seizures that also have brain anomalies that require monitoring, such as tuberous sclerosis, brain tumors or multiple sclerosis, as well as those with non-brain MRI requirements, can now be offered the RNS System as a treatment option.