Devices
FDA has approved Allergan Aesthetics’ Juvéderm Volbella XC for an additional indication — improving infraorbital (undereye) hollows in adults over the age of 21. As part of the approval, FDA is requiring the company to provide a product training program for all interested providers, which includes facial anatomy and considerations for
Drugs
Five King & Spaulding lawyers say a 12/2021 FDA draft guidance on digital health technologies (DHTs) is a “pandemic silver lining.” In an online post, the lawyers say the draft describes the agency’s thinking about how sponsors, study investigators, and others can use DHTs to gather health-related
Devices
FDA has rejected a Pulse Biosciences 510(k) for an expanded indication to treat sebaceous hyperplasia with its cleared CellFX System powered by Nano-Pulse Stimulation technology. In a 2/5 Additional Information letter, the agency said the company had not provided sufficient clinical evidence at this time to support
Devices
Former CDRH orthopedic device medical officer Stephen Weber has joined consultant group NDA Partners. “During his FDA career, Dr. Weber conducted reviews of orthopedic devices including upper extremity devices, spine, hip, knee, and ankle devices, combination products, and surgical device products,” the company says. He was also a member of
Devices
FDA is warning health care providers, parents and caregivers of pediatric patients who receive enteral feeding that there is a risk of strangulation from using enteral feeding delivery sets. According to an FDA safety alert, the feeding set tubing can become wrapped around a child’s neck and cause strangulation
Drugs
The Department of Justice (DoJ) says it obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims against the government in FY 2021. A department statement says it is the second-largest annual total in False Claims Act history and the largest
Devices
FDA has cleared an Ambu 510(k) for its Ambu aScope Gastro and Ambu aBox 2 display, the company’s first sterile single-use gastroscope, which includes new advanced imaging and next-generation display and processor technology. The sterile single-use device is intended to address growing cross-contamination risks,
Drugs
A just-released Government Accountability Office report has offered recommendations on an FDA planned pilot program to test unannounced foreign inspections. The pilot will look at bringing foreign inspections on equal footing with domestic inspections, which traditionally have been unannounced. The agency is also looking at eliminating the option of
Devices
FDA has issued a warning to not use the E25Bio Covid-19 Direct Antigen Rapid Test (DART). “This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it may include false labeling representing that the test is authorized by
Drugs
FDA says it is lifting its domestic inspection pause and will resume conducting inspections in the U.S beginning 2/7 across all commodities now that Covid-19 cases are dramatically declining. “In addition to the resumption of planning and conducting domestic surveillance inspections on 2/7, the FDA continues
Drugs
Reps. Anna Eshoo (D-CA), Brian Fitzpatrick (R-PA), and Robin Kelly (D-IL) have introduced the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act. They say (includes a link to the bill text) the measure is intended to boost diversity in clinical trials by requiring enhanced data reporting
Devices
CDRH has published its three strategic priorities for 2022-2025. The document says the priorities are to promote a modern and diverse workplace, enhance organizational agility and resilience, and advance health equity. The report discusses progress made on the strategic priorities the Center set in 2018 and amplifies the three
Drugs
Two Hogan Lovells attorneys say companies operating in the telemedicine and electronic health records (EHR) spaces should expect increased False Claims Act (FCA) enforcement going forward and take steps to minimize their risk. The attorneys’ views are expressed in a white paper, “Healthcare Digitization Creates New FCA Risk.” “In recent
Devices
FDA has cleared a Bone Solutions 510(k) for its Mg Osteorevive, a magnesium-based injectable and moldable bone void filler indicated for posterolateral spine fusion procedures. The company says that magnesium is a critical component for bone health and development, and plays a key role in the absorption and
Devices
FDA has cleared a VySpine 510(k) for the ClariVy Cervical IBF System and its use in anterior cervical discectomy with fusion procedures. It features cervical interbody fusion devices made from either Polyetheretherketone (PEEK) Optima LT1, or PEEK Optima HA-Enhanced. “PEEK Optima LT1 has been the standard for interbody
Devices
FDA says the Empowered Diagnostics 12/22/21 recall of all lots of its CovClear Covid-19 rapid antigen test and ImmunoPass Covid-19 neutralizing antibody rapid test is Class 1. An agency statement says at least 284,575 antigen tests were recalled in the U.S. and at least
Devices
Despite being one of the busiest years at CDRH due to Covid-19, the Center was still able to grant marketing authorizations for 103 novel devices last year, according to a just-released CDRH annual report. The pandemic has also highlighted how vulnerable supply chains are and the Center’s
Devices
Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) are urging FDA to quickly finalize its proposed rule on over-the-counter (OTC) hearing aids. In a statement (contains a link to the letter), the senators say the proposed rule is a result of their Over-the-Counter Hearing
Biologics
FDA would have many responsibilities in the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act) released 1/25 by Sens. Patty Murray (D-WA) and Richard Burr (R-NC), the chair and ranking member of the Senate HELP Committee. Murray and Burr
Devices
CDRH has issued the 2021 annual report on the Accreditation Scheme for Conformity Assessment pilot program. The program is designed to enhance the use of declarations of conformity that should translate into greater consistency and predictability in the agency’s approach to assessing conformance to standards in medical device review
Devices
Philips Respironics has recalled certain Trilogy Evo ventilators due to potential health risks caused by a polyester-based polyurethane sound abatement foam that a supplier incorrectly used in the muffler assembly of the affected devices. The issue was identified during lab testing, according to a recall notice. The recalled ventilators
Devices
FDA has published a guidance, Patient Engagement in the Design and Conduct of Medical Device Clinical Studies, on the value of patient and caregiver experiences and perspectives to medical device studies. The document is intended to: * help sponsors understand how they can voluntarily use patient engagement to elicit experience, perspectives,