Devices
FDA Posts Revised Audit Time Determination Procedure
FDA has posted a revised Medical Device Single Audit Program P0008 audit time determination procedure and related forms. The document contains six revisions dated 1/24.
Devices
Devices
FDA OKs Expanded Efficacy Claim for Arthritis Injection
FDA has approved an expanded efficacy claim for Zimmer Biomet Holdings’ single-injection viscosupplement Gel-One Cross-linked Hyaluronate for treating knee pain associated with osteoarthritis. The 26-week efficacy claim is associated with the product’s treatment of pain in osteoarthritis of the knee in patients who have failed
Devices
Medtronic CardioInsight Mapping System Cleared
FDA has cleared a Medtronic 510(k) for the CardioInsight Noninvasive 3D Mapping System, intended for use in mapping irregular heart rhythms in the upper and lower chambers of the heart, and providing electroanatomic 3D maps of the heart. Cardiac mapping has traditionally been processed by inserting a catheter into
Drugs
FDA Not Conceding on Off-label Communications: Attorneys
Skadden Arp attorneys have issued a paper analyzing several documents FDA issued in the waning hours of the Obama administration staking out a strong position on its ability to regulate manufacturer communication on off-label uses. “Because the identity of the next FDA commissioner is still unknown,” the paper says,
Devices
Quality System Violations at Germany’s Biotronik
A 3/7-3/10/16 FDA inspection at Biotronik SE & Co., Berlin, Germany, found Quality System Regulation violations in the firm’s manufacturing of Selectra percutaneous catheters, Galeo coronary guide wires, implantable pacemakers, and implantable cardioverter defibrillators. A just-released 9/1/16 Warning Letter says that specific
Devices
2 NICO Brain Surgery Devices Cleared by FDA
FDA has cleared two devices made by NICO Corp. that are used in a new approach to brain surgery. NICO received 510(k) clearance for specific neurosurgical indications on its Myriad automated tissue removal handpiece. The new clearance provides specific disease state approval for primary and secondary brain tumors, vascular
Devices
Cures Act Answers Some Software Questions: Attorney
The 21st Century Cures Act provides some clarity on categories of software that are excluded from the statutory medical device definition and thus FDA jurisdiction, according to attorney Suzan Onel (Kleinfeld Kaplan & Becker.) Writing in an online Alert, Onel says that even with the clarification, some questions remain, particularly
Devices
12 QS Violations in Ropack Inspection
A 1/18-1/21/16 FDA inspection at Ropack, Inc., Montreal, Canada, found 12 Quality System Regulation violations in the firm’s manufacturing of artificial saliva. Specific violations noted on an FDA-483 included: * failing to ensure that when the results of a process cannot be fully verified by
Devices
FDA Approves Gore Balloon Expandable Endoprosthesis
FDA has approved a W. L. Gore PMA for the Gore Viabahn VBX Balloon Expandable Endoprosthesis for treating de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation. The device’s approval was based on a study that “demonstrated notable immediate and nine-month safety
Devices
Bard Recalls Halo One Guiding Sheath
Bard Peripheral Vascular has recalled its Halo One Thin-Walled Guiding Sheath because the sheath body may separate from the sheath hub while removing the device from a patient’s leg. The company also reports that the sheath may kink, and that its tip may become damaged during the procedure,
Devices
Zeltiq Aesthetics’ CoolSculpting Cleared for Upper Arm Fat
FDA has cleared a Zeltiq Aesthetics 510(k) for the CoolSculpting device and its use for removing fat on upper arms. The upper arm area will be treated using the company’s CoolAdvantage Petite applicator, which comes with two interchangeable contours designed to treat the area in 35 minutes, the
Devices
BioMerieux Expands Class 1 Recall
BioMerieux has expanded an 8/2016 Class 1 recall of its NucliSENS easyMAG Magnetic Silica (MagSil) because of effects on nucleic acids extraction performance. MagSil is used to extract and purify genetic material from patient samples. “Kits with the affected lots of the Magnetic silica have exhibited a decrease of
Devices
FDA Clears Depuy Synthes Spinal Screw Systems
FDA has cleared a DePuy Synthes 510(k) for the Viper and Expedium Fenestrated Screw Systems. When used with the company’s Confidence High Viscosity Spinal Cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors, the company says. The
Devices
Medical Device Prospective Active Surveillance Works: Study
An FDA-funded study reported in the New England Journal of Medicine says that a strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular closure device. Initial reports occurred within the first 12 months of monitoring, the report says.
Drugs
FDA Looking for Drug Quality Metrics
FDA plans to request data on pharmaceutical quality metrics and has proposed guidance on data collection and submission, according to the Deloitte Life Sciences Regulatory Outlook for 2017. The document says the proposed guidance would change how FDA schedules its inspections, helping to promote modernization of the drug industry and
Drugs
Cures Act Clarifies Combination Product Designation: Attorneys
Hogan Lovells attorneys say that one of the features of the 21st Century Cures Act is an attempt to bring consistency and efficiency to the regulation of combination products. In an online blog post, the firm says that the new law brings two important clarifications to the process of determining
Devices
FDA Approves FujiFilm Mammography Upgrade
FDA has approved a FujiFilm Medical Systems PMA for the Digital Breast Tomosynthesis (DBT), as an optional software upgrade for its ASPIRE Cristalle digital mammography system. “With the DBT software option, the x-ray tube moves through an arc around the breast, acquiring a series of low-dose image slices
Devices
Stakeholders Disagree with Parts of GLP Proposal
Pfizer says that while it agrees that the current good laboratory practice (GLP) regulations need to be modernized, it does not agree that the conduct of certain early stage safety or efficacy studies needs to be done in accordance with GLP. Responding to an FDA proposed rule, the company says
Devices
CDRH de novo Clearance of Wound Retraction Device
CDRH has granted de novo clearance for Prescient Surgical’s CleanCision Wound Retraction and Protection System for surgical wound edge protection, retraction, and continuous cleansing with a sterile irrigant solution. The device may also aid in preventing wound edge contamination, “a powerful advance towards mitigating associated infections,” the company says.
Devices
Five Areas to Address in Cybersecurity: Webinar
An FDA 1/12 webinar on the agency’s final guidance on postmarket management of cybersecurity in medical devices says that addressing this issue means implementing a proactive comprehensive risk management program that incorporates several tenets: applying the NIST (National Institute of Standards and Technology) framework to strengthen critical infrastructure
Devices
FDA ‘Discussion Paper’ on Laboratory Developed Tests
Three Sidley Austin attorneys say that FDA took the unusual but not unprecedented step of issuing 1/13 a paper, “Discussion Paper on Laboratory Developed Tests (LDTs)” that proposes a new regulatory framework for such tests. Writing in an online blog post, the attorneys say the paper describes a risk-
Drugs
Could ‘Park Doctrine’ be Overturned?
A case being appealed to the Supreme Court says the court should overturn two earlier decisions that are the foundation of what has come to be known as the “Park Doctrine” or the responsible corporate officer doctrine. Attorney Jennifer Thomas (Hyman, Phelps & McNamara) writes in her firm’s FDA