Drugs
Attorney John Bentivoglio (Skadden Arps) says that corporate integrity agreements (CIAs) are “important to those operating under their obligations and to others in the same healthcare sector. They provide important guidance as to what the OIG believes to be effective oversight and operational controls for healthcare organizations. Companies should review
Devices
Colorado Therapeutics has submitted a 510(k) for its xenogenic biologic tissue matrix, intended for use in reinforcing soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes, including hernia defects. The company says the product has been developed in a dry state
Devices
Issues that did not receive full discussion due to time constraints at a 12/15/15 MDUFA $ reauthorization meeting included 510(k) total time to decision reduction, third-party 510(k) review, digital health, leveraging standards, device-specific guidance, PMA process enhancements and total product life cycle, access to review
Devices
FDA has cleared a Velano Vascular 510(k) for a modified version of its Velano needle-free blood draw device. The device clearance, according to the company, covers two modifications designed to enhance the product’s usability for inpatient blood draws — the addition of a clamp for use with syringe
Devices
FDA has cleared a PuraCath Medical 510(k) for the FireFly Peritoneal Dialysis Connector Disinfecting System, intended for use by peritoneal dialysis (PD) patients as a method of controlling air and touch contamination while performing solution exchanges. The clearance was supported by in vitro testing that the company says demonstrated
Drugs
FDA deputy commissioner for medical products and tobacco Robert Califf says that increasing diversity in clinical trial participants is a priority for the agency and “we want to make 2016 the year of more diversity in clinical trials.” Writing in an FDA Voice blog post, Califf reviews things the agency
Devices
The West Virginia federal court has invoked the doctrine of primary jurisdiction to remand a potential class action suit against Boston Scientific charging violations of the Racketeering and Corrupt Organizations Act (RICO) on behalf of women who have suffered severe discomfort, bleeding, infections, painful intercourse, urinary problems, and other complications
Devices
FDA has classified as Class 1 a Thornhill Research revised recall of its Moves Ventilator System because excess glue on the battery connectors may prevent it from powering the device after the battery is stored. The defect may prevent the ventilator from providing patient breathing support and could cause patient
Devices
A five-month inspection at Invacare, Elyria, OH, found that the company is not living up to terms of a consent decree for its wheelchair manufacturing operations signed with FDA in 2013, a Crain’s Cleveland Business report says. An FDA-483 listed the inspection period as 7/16/15
Devices
Former FDA special assistant to the associate commissioner for regulatory affairs Martin Browning, now president of EduQuest, says that an inspected company’s response to an FDA-483 observation “is your last and best opportunity to tell your side of the story before higher-ups in the agency (including enforcement
Devices
An 8/31-9/1/15 FDA inspection at LAR MFG, Port Richey, FL, found Quality System Regulation violations in the firm’s manufacturing of ceramic dental brackets, according to a just-released 12/9/15 Warning Letter from the agency’s Florida District Office. Specific violations noted on an
Devices
FDA has posted a new draft guidance on “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices” that identifies specific considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices.
Devices
A Duval law firm client alert discusses the importance of 510(k) submitters persuading FDA that chosen indications for use fall under the umbrella of the chosen intended use statement. If they do not, the subject device will be found “not substantially equivalent.” The alert cautions that “FDA frequently interprets
Drugs
New England Journal of Medicine editors say they will only accept articles whose authors commit to make available the underlying data supporting reported results within six months after publication. “In the process of formulating our policy, we spoke to clinical trialists around the world,” a NEJM editorial says. “Many were
Devices
FDA has cleared an Entrotech Life 510(k) for its ChloraDerm, an edge-to-edge transparent film dressing to provide a chlorhexidine matrix for wound and catheter site protection for up to seven days. “Compared to common non-antimicrobial dressings ChloraDerm demonstrates substantially greater effectiveness against multi-drug-resistant organisms
Devices
St Jude Medical Cardiac Rhythm Management Division has begun a Class 1 recall of its Optisure Dual Coil Defibrillation Leads, Model Numbers LDA220, LDA220Q, LDA230Q, and LDP220Q, which are designed for long term attachment to an implantable cardioverter defibrillator. A recall notice says leads may have been compromised during the
Devices
Advanced Medical Technology Association (AdvaMed) says FDA needs to provide more input on device manufacturing site change submissions. In just-posted comments on an FDA draft guidance on “Manufacturing Site Change Supplements: Content and Submission,” the group says more details are needed on the types of manufacturing site changes that
Devices
FDA has cleared an Intuitive Surgical 510(k) for an integrated operating table motion claim for the da Vinci Xi Surgical System. Integrated table motion combines the da Vinci robotic-assisted surgical system and Trumpf Medical’s advanced operating table, the TruSystem 7000dV, to allow surgeons and anesthesiologists the ability
Devices
FDA has cleared a Centinel Spine 510(k) for the ALTOS posterior cervical thoracic stabilization system indicated for use in either the lateral masses of the cervical spine or the pedicles of the cervical-thoracic spine The low profile, stabilization system offers both fully threaded and smooth shank polyaxial screws
FDA Policy/General
The 9th Circuit Court of Appeals says that a California federal court erred in granting the federal government’s motion to compel production of many attorney-client documents as part of an obstruction of FDA case involving 1-800-Get-Thin, a weight loss call center that marketed the LapBand
Devices
FDA has cleared a Pelvalon 510(k) for its next generation Eclipse System for women suffering from loss of bowel control. According to the company, it is the first vaginal insert designed to provide immediate bowel control. The original version of the device was granted marketing clearance under the de
Devices
FDA has published a guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to update and clarify the information regarding sterilization processes that FDA recommends that sponsors include in 510(k)s for devices labeled as sterile. The document says it