Devices
CDRH, the National Health Information Sharing and Analysis Center, and the Medical Device Innovation, Safety and Security Consortium have signed an agreement to collaborate in areas of mutual interest, such as sharing information on cybersecurity vulnerabilities that may affect medical devices or the integrity and security of the surrounding healthcare
Devices
FDA has issued a guidance, Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, with a detailed description of the information to be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). The document says it is to be used in conjunction with information in other places
Drugs
An HHS inspector general’s (IG) report on the top management and performance challenges facing the agency says that FDA’s challenges include drug compounding, the complex drug supply chain, improper marketing activities, and food safety. The report describes each challenge, the progress made in addressing it, and what remains
Devices
Members of the FDA Microbiology Devices Panel of the Medical Devices Advisory Committee recommended 11/9 down-classification of quantitative cytomegalovirus (CMV) viral load devices from Class 3 to Class 2. Meeting minutes indicate that committee members said the down-classification would require development of carefully crafted special controls covering
Drugs
Four Hogan Lovells attorneys say that new policies introduced by the National Institutes of Health (NIH) in recent months “put pressure on the research compliance infrastructure across a broad swath of NIH awardees, including universities, hospitals, and medical institutions.” The attorneys summarize three policies — ClinicalTrials.gov requirements, good clinical practice
Devices
FDA says that HeartWare has recalled 105 ventricular assist devices manufactured between 7/31/14 and 3/30/16. An agency notice says that the pumps were recalled due to a design problem with the driveline connector. Contamination of the driveline, it says, may result in fluid or other material
FDA Policy/General
Regulatory consulting firm Greenleaf Health has brought on two former senior FDA officials — former Office of Regional Operations director David Elder and former CDRH associate director for regulations and policy Kate Cook. At Greenleaf, Elder joins the firm’s Product Quality, Manufacturing & Compliance group, where he will provide “strategic
Devices
Attorneys Michele Buenafe and M. Elizabeth Bierman (Morgan, Lewis & Bockius) say there are questions raised by an FDA 10/14 draft guidance on clinical evaluation of software as a medical device (SaMD). The guidance was developed by the SaMD working group of the International Medical Device Regulators Forum (IMDRF)
Drugs
A 6/13-17 FDA inspection at Sekisui Medical Co., Tokyo, Japan, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to an 11/8 Warning Letter. Specific deviations included: * failing to maintain complete data derived from all laboratory tests conducted to ensure compliance with
FDA Policy/General
[Analysis by Angi Robinson and Juliet Moritz*] Anyone who works in drug development will tell you this is a business of longshots. More than 90% of the compounds that reach clinical testing fail, and many more never make it that far. Add to those long odds the enormous time and
Drugs
The Stericycle Expert Solutions Q3 recall index finds that medical device recalls were up, while drug recalls were down in the third quarter of 2016. Medical device recalls reached their highest level since at least 2000, the report says, rising by 29% over the previous quarter to 339. Recalled units
Devices
FDA says that Bayer’s controversial Essure permanent birth control system has new labeling that includes a Boxed Warning and a Patient Decision Checklist, “both intended to support patient counseling and understanding of benefits and risks associated with Essure, as well as what to expect during and after the Essure
Drugs
Attorney James Beck (Reed, Smith) looks at five ways in which a Trump administration might affect the drug and medical device product liability space: * FDA’s proposed final rule to abolish generic preemption by enacting regulations that likely violates the Federal Food, Drug, and Cosmetic Act’s “sameness” requirement for
Devices
FDA has approved Medtronic’s Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device for patients with heart failure. The device is approved for scanning in both 1.5 and 3 Tesla magnetic resonance imaging machines, and features EffectivCRT, a new algorithm that personalizes therapy to individual patients
Devices
FDA has cleared a CapsoVision 510(k) for the CapsoCam Plus small bowel capsule endoscope system. The device comprises a capsule endoscope, a retrieval kit, a data access system, and software, which work together to provide a “streamlined, patient-friendly examination,” the company says. “CapsoCam Plus is the only capsule
Devices
Thermo Fisher Scientific today has submitted the final module of a PMA for its Oncomine Universal Dx Test, a multi-gene, next-generation sequencing-based assay for non-small cell lung cancer (NSCLC). “If approved, the universal gene panel could be the first of its kind in the United States,
Devices
Pennsylvania-based medical device manufacturer Biocompatibles has pleaded guilty to misbranding its embolic device LC Bead and will pay more than $36 million to resolve criminal and civil liability arising out of the illegal conduct. LC Bead is used to treat liver cancer, among other diseases. The device was cleared
Drugs
The HHS Office of Inspector General 2017 work plan includes five items relating to FDA oversight of drugs and medical devices. The document lists: * evaluation of hospitals’ reliance on drug compounding outsourcing facilities; * FDA’s review of networked medical device cybersecurity during the premarket process; * response planning for a networked
Drugs
A new nationally representative poll of more than 1,000 adults by Consumer Reports (CR) reveals that most Americans (84%) do not want companies to be allowed to advertise drugs for a use that has not been approved by FDA. The survey results (XXINSERT LINKXX) were shared at the second
Drugs
Yale University’s Collaboration for Research Integrity and Transparency renews its sharp criticism of the pending 21st Century Cures Act as “a disaster still,” despite changes, for its likely weakening effects on FDA regulation of medical products. Despite some changes since it was introduced, the pending 21st Century Cures Act
Drugs
Senate majority leader Mitch McConnell (R-KY) has reiterated that he is “redoubling” his push to see the 21st Century Cures Act, legislation to accelerate the cycle of discovering, developing, and delivering new cures and treatments to patients, signed into law this year. “There are two priorities for me for
Devices
FDA has launched a new Web site to help sponsors and innovators to bring neurological medical devices to the U.S. marketplace. The agency says the Web site provides: * an overview of the FDA regulatory process and how it applies to developers and sponsors of neurological devices; * standards and guidances