Devices
FDA has cleared a 7D Surgical 510(k) for its Machine-vision Image Guided Surgery system for spine surgery. The company says the device uses “3D optical technologies and machine vision algorithms to eliminate the long-standing barriers to adoption of existing surgical navigational platforms. This new technology can easily
Devices
FDA has cleared an OssDsign 510(k) for the OssDsign Cranial PSI, a patient-specific medical implant intended for reconstruction of cranial defects (cranioplasty). Such procedures have traditionally been performed by neurosurgeons using a patient’s own bone or by using implants made from inert plastic or metal materials, such
Devices
FDA has cleared a Bone Index Ltd. 510(k) for its second generation Bindex point-of-care device model to help in osteoporosis diagnosis. The device measures the cortical bone thickness of the tibia and its algorithm calculates a “Density Index,” a parameter which estimates bone mineral density at the
Drugs
In one of his final acts as FDA commissioner, Robert Califf announced 1/19 that the agency is officially establishing the Oncology Center of Excellence, with Richard Pazdur as its director. “This will make oncology the first disease area to have a coordinated clinical review of drugs, biologics, and devices
Devices
A 10-week FDA inspection at Zimmer Biomet from 9/12/16 to 11/22/16 led to a 58-page FDA-483 detailing 14 inspection observations, some of which were repeated from earlier inspections. The just-released document shows these violations: * failing to adequately validate according to established procedures
Devices
AdvaMed and Abbott Laboratories say an FDA proposed rule on electronic submission of labeling for certain home-use medical devices is redundant and should not be pursued. The AdvaMed comment letter says the rule is not needed because device labeling information is widely available to users, and many manufacturers of
Drugs
As part of FDA’s reexamination of its rules and policies relating to regulated industry communication on unapproved uses of approved or cleared medical products, the agency has submitted a memorandum to the docket “to provide additional background and seek input on the full range of issues to consider as
Drugs
HHS, FDA and 13 other federal agencies have issued a final rule updating regulations that safeguard individuals who participate in research. The agencies say that most provisions in the rule take effect in 2018. “The new rule strengthens protections for people who volunteer to participate in research, while ensuring that
Devices
An ongoing CDRH customer service satisfaction survey score has slipped from 88% of respondents in 2015 reporting that they had received satisfactory responses or information in their Center interactions to a 84% satisfactory rating as of this month. While the survey score has fallen a few points, CDRH says it
Devices
Ropes & Gray attorneys say that medical device manufacturers should review a recent FDA final guidance on postmarket management of medical device cybersecurity and consider how to incorporate its recommendations into their postmarket management activities. In an online regulatory alert, the attorneys say that FDA recommends that manufacturer cybersecurity risk
Devices
The CDRH Office of Compliance issued 17 Warning Letters in 2016, with 16 of them relating to Medical Device Reporting (MDR) violations. Inside Medical Devices, published online by Covington & Burling, says that seven letters determined that the company did not have written MDR procedures that satisfied regulatory requirements, while
Drugs
FDA has posted a new draft guidance on “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers” dealing with how the agency evaluates firms’ medical product communications that present information that is not contained in, but may still be consistent with, the FDA-required labeling.
Devices
FDA is providing an updated Safety Communication to inform users about a design issue with the Pentax ED-3490TK duodenoscope that could increase the risk of patient infection. The communication contains updated recommendations to help prevent the spread of infection associated with the use of these devices. “Cracks and gaps
Devices
FDA says Fujifilm Medical Systems has decided to remove from the market older-model (250/450) duodenoscopes based on the limited number currently in use. Fuji will replace them with the ED-530XT model, in addition to necessary accessories (i.e. brushes) at no cost, a safety alert says. The
Devices
An FDA discussion paper on laboratory developed tests (LDTs) outlines a new proposal to provide oversight of such devices. Recently, the agency announced that it would not issue a final guidance on LDT oversight at the request of various stakeholders to allow for further public discussion on an appropriate oversight
Devices
FDA has released a final guidance on “Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions.” The document is intended to provide greater clarity on the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human clinical studies. The
Drugs
Attorneys Benjamin Zegarelli and Eli Greenspan (Mintz Levin) say that an FDA 1/9 final rule amending the definition of “intended use” for drugs and medical devices, which could be subject to congressional rollback, is something that industry might prefer to keep on the books. Writing in an online blog
Devices
FDA has cleared a SonaCare Medical 510(k) for its latest version of Sonablate, a high-intensity focused ultrasound device intended for focused ablation of prostate tissue. The company says the improved device includes new and updated features such as: Tissue Change Monitoring, a tool that quantifies radiofrequency signals for
Devices
FDA says it has received reports of serious adverse events, including patient injury and death, associated with use of implantable infusion pumps in the magnetic resonance (MR) environment. An agency safety communication says the reports describe medication dosing inaccuracies such as over- or under-infusion and unintended bolus, and other
Devices
Bayer has begun a Class 1 recall of its Medrad Intego PET Infusion System Source Administration Sets due to particulates generated in vials. The particulates may be created when the tip of the needle pushes through the rubber top of the vial. If this occurs, the particulate matter could enter
Drugs
FDA says it is encouraging more patients to participate in clinical trials, especially people of different ages, races, ethnic groups, and genders. An agency Consumer Update says that overall, few people sign up for and participate in trials, and those who do participate don’t always represent the U.S.
Drugs
FDA has made available a final guidance entitled “Current Good Manufacturing Practice Requirements for Combination Products.” The document describes and explains GMP requirements for combination products, which published in the Federal Register 1/22/2013. It also includes general considerations for maintaining GMP compliance, as well as analysis of hypothetical