Devices
A 10/11-10/26/22 FDA inspection at Synovo Production in Fullerton, CA, determined that the firm is the specification developer, manufacturer, and distributor of a femoral resurfacing cup that is distributed as a standalone product and as part of a total hip system. A 3/23 Warning Letter
Devices
FDA has granted a de novo marketing authorization to Happiest Baby for its SNOO, a medical device for keeping sleeping babies safely on their backs. “The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep,” the company says. Infants who
Devices
Datascope has recalled its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps due to a communication loss between the devices’ executive processor printed circuit board assembly (PCBA) and their video generator PCBA which may cause an unexpected shutdown. The shutdown can occur without warnings or alarms to alert the user,
Devices
FDA says it is evaluating safety concerns with the use of certain dental devices that are fixed (non-removable) palatal expanders and used on adults to remodel the jaw or treat conditions. An agency safety communication says the devices of concern are: * anterior growth guidance appliance and fixed anterior growth
Devices
FDA has published a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions, to provide “a forward-thinking approach to promote the development of safe and effective medical devices that use machine learning (ML) models trained by
Devices
Reps. Larry Buschon (R-IN) and Diana DeGette (D-CO) have reintroduced the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, that they say would create a new framework to verify the accuracy of various medical tests that doctors and patients rely on to make important health decisions. In a
Devices
FDA has approved an Abbott PMA supplement for Epic Max, a stented tissue valve to treat people with aortic regurgitation or stenosis. The device is the latest addition to Abbott’s Epic surgical valve platform. Such valves are recommended for patients requiring valve replacement who aren’t suitable for blood
Devices
An FDA guidance, Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act, says the agency does not intend to issue “refuse to accept” decisions for premarket submissions submitted for cyber devices before 10/1 based solely on the information
Devices
Artificial Intelligence/Machine Learning (AI/ML) regulatory principles are in greater flux and progressing at a greater rate than any other area of FDA regulatory oversight. That’s the view of attorney Jesse Atkins (Gardner Law) in an online post. “In a discipline as dynamic as this,” he writes, “the
Devices
FDA has published a draft guidance, Orthopedic Non-Spinal Bone Plates, Screws, and Washers—Premarket Notification (510(k)) Submissions, with recommendations for such submissions for non-resorbable bone plate, screw, and washer devices. The document says the devices are installed for orthopedic bone fixation and exclude indications for spinal, mandibular,
Devices
FDA is making available a final guidance entitled “General Considerations for Animal Studies Intended to Evaluate Medical Devices.” The document is intended to assist medical device sponsors, testing facilities, and other persons involved in designing, conducting, and reporting the results of animal studies that are conducted to assess device safety
Devices
FDA is making available a final guidance entitled “Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for soft (hydrophilic) daily wear contact lenses in support of the Safety and Performance Based Pathway. Under this framework, companies planning to submit
Devices
FDA has cleared a Vaporox 510(k) for its next-generation VHT-200 medical device system for healing chronic wounds. “Vaporox’s Vaporous Hyperoxia Therapy (VHT) is a breakthrough technology that has been clinically validated as a safe and effective adjunct treatment for healing skin wounds,” the company says. VHT
Devices
FDA has issued two final guidances on transition plans for Covid-19-related medical devices that were granted emergency use authorizations or were allowed to be marketed under the agency’s enforcement discretion policy. The guidances outline the agency’s general recommendations to transition from policies/operations implemented during the
Devices
CDRH has launched a new Web page to discuss “mission-critical priorities of data and technology innovations” and provide information and resources on its Diagnostic Data Program. The page describes two focus areas: (1) Systemic Harmonization and Interoperability Enhancement for Laboratory Data, and (2) Digital Diagnostics: Over-the-Counter and
Devices
FDA has approved a Getinge PMA for its iCast covered stent system for treating patients with iliac arterial occlusive disease, which is a type of peripheral arterial disease caused by atherosclerosis. The company says iCast, which is sold outside the U.S. under the brand Advanta V12 covered stent, has
Drugs
FDA has published a framework that it says it will use to implement a multifaceted digital health technologies (DHT) program for drugs. The document notes that the PDUFA 7 commitment letter stating the agreements between the agency and industry for reauthorization of PDUFA, included goals relating to using DHTs to
Devices
FDA has added the Xtrava Health SPERA Covid-19 Ag Test to the list of tests expected to have a reduced performance with certain SARS-CoV-2 Omicron sub-variants. The Xtrava test was added to the FDA Web page on SARS-CoV-2 Viral Mutations: Impact on Covid-19
Devices
FDA-funded research conducted by the Smith Center for Outcomes Research at Boston’s Beth Israel Deaconess Medical Center has determined that newer unibody aortic stent grafts failed to outperform the older non-unibody devices through a median follow-up period of 3.4 years. A medical center media statement
Devices
FDA is reminding patients and healthcare providers about Exactech joint replacement devices that were manufactured between 2004 and 8/2021 and were recalled in 2021 and 2022. An agency notice says many of the Exactech knee, ankle, and hip joint replacement devices were packaged in defective packaging bags. “The defective
Devices
CDRH director Jeff Shuren says one of the biggest concerns that keeps him up at night is medical device cybersecurity. Speaking at 3/23 Alliance for Stronger FDA Webinar, Shuren said the recent omnibus budget bill provided FDA with $5 million to finally build a desperately needed cybersecurity program. He
Devices
FDA says events involving squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants should be reported to a registry developed by the agency, the American Society of Plastic Surgeons and the Plastic Surgery Foundation. The registry is the latest action to occur following a 3/