The FDA said makers of imaging systems should include information pertaining to pediatric exposure in their premarket filings for X-ray imaging systems. The final guidance for pediatric information for X-ray imaging system 510(k) applications is based on the May 10, 2012, draft guidance, although the scope of the final includes X-ray system accessories, which were excluded from the terms of the draft. The draft stated that an imaging system that takes into account the smaller sizes of adult patients "should be able to competently image" the typical pediatric patient of at least 12 years of age, a concession that does not appear in the final guidance. The final guidance expands the discussion of risk assessment to include a reference to the 2014 guidance titled, "Premarket Assessment of Pediatric Medical Devices." Both documents state that the agency will request clinical images of pediatric patients only when lab testing does not suffice to demonstrate substantial equivalence, although the final adds the mandate that this would be the case also when extrapolation of data from adult images is "not sufficient" to support a claim of substantial equivalence. The agency will hold a Jan. 9, 2018, webinar to review the final guidance.
The U.K. National Institute for Health and Care Excellence has opened the comment period for the use of laparoscopically implanted mesh to treat uterine/vaginal prolapse, stating that the evidence for effectiveness includes a randomized trial comparing the device/procedure with surgical, non-mesh cervicopexy, which disclosed no statistically significant difference in terms of relapse of the condition. The agency said patient satisfaction was similar between the two groups, although the numbers trended toward the mesh arm, while mean blood loss was significantly lower in the mesh group. Operating room time again favored the minimally invasive implant of mesh (43 minutes compared to 52 minutes for conventional surgery), although post-operative voiding difficulties favored conventional surgery. De novo urinary urgency was higher among the surgical patients at 20 months (17 percent) than for mesh patients at 22 months (7 percent), while stress urinary incontinence was 5 percent in both arms. The draft recommendation is that meshes for this indication be used only in clinical studies, and be implanted only by surgeons with the requisite training and experience. NICE is taking comment through Dec. 22, 2017.
The FDA said the regulatory review period for the Senza spinal cord stimulation system by Nevro Corp. of Redwood City, Calif., was 1,136 days, divided into 820 days for development and 316 days in the approval phase. The company is seeking a patent term extension of 312 days, and Senza and the FDA are in concurrence as to the PMA filing and approval dates, which were June 27, 2014, and May 8, 2015, respectively. Interested parties can comment on whether the sponsor acted with due diligence during the regulatory review period through May 27, 2018, while those who wish to comment on the dates in question must register any objections by Jan. 27, 2018. The related docket numbers are FDA-2016-E-1195 and FDA-2016-E-1534.
The U.S. Nuclear Regulatory Commission has scheduled a Jan. 23, 2018, meeting to review an application by Northwest Medical Isotopes LLC of Corvallis, Ore., for construction of a medical isotope plant to be located in Columbia, Mo. The city is the home of the University of Missouri's medical isotope research reactor, and Northwest's facility would be located at the site of the university's Discovery Ridge Research Park.
The European Medicines Agency said its new guidelines for good manufacturing practices for advanced therapies apply to articles that are in clinical trials as well as those that have been granted marketing authorization. The new guidelines, which overwrite a document published in 2009, will apply to gene- and cell-based therapies, but do not appear to apply to therapies delivered via gene editing technologies. Among the provisions of the guidelines is that adaptations can be made for sterility assurance when the short life of the product does not permit the use of standard approaches to sterility assurance. The agency said that any clinical site that has been validated for processing of minimally manipulated cells and tissues for transplantation under alternative guidelines need not be re-validated under the new EU guidelines so long as those alternatives guidelines "can be deemed comparable." The European Commission has vowed to publish by the end of 2018 a set of guidelines for clinical study of investigational ATMPs that would apply across all member states.
Repro-Med Systems Inc. of Chester, N.Y. has won a Nov. 20, 2017, close-out letter for the Feb. 26, 2016, FDA warning letter for the company's infusion pumps stemming from a June 2015 inspection. The warning letter cited the company for promoting the Freedom 60 pumps for indications not cleared under the then-existing 510(k) filing (K933652) as well as for changes to operational specifications, including pump pressure and flow rate. Other violations include failure to adequately verify/validate changes to the design for the Freedom Edge syringe infusion pump, and for procedures that did not include sufficient instructions for calibration of equipment used to test the company's infusion pumps. Repro-Med said in a Nov. 27 statement that the close-out was due principally to a revised 510(k) catch-up filing for the Freedom system, which now includes indications such as delivery of immunoglobulins and antibiotics, indications that were cited as violative in the warning letter. CEO Andy Salfon said the company is "thrilled and excited that FDA has recognized the leading edge concept of a constant-pressure infusion system."
The Agency for Healthcare Quality and Research said the rate of hospitalizations for acute renal failure as a primary diagnosis rose from 95 per 100,000 U.S. citizens in 2005 to 158 in 2014. The report, part of AHRQ's Hospital Cost and Utilization Project (HCUP) series, said the rate of hospitalizations listing acute renal failure as a secondary diagnosis nearly tripled over that same period of time to 1,011 per 100,000, and that the average cost of hospital stays in which the condition was reported as a primary or secondary diagnosis was double that of stays not associated with renal failure. The most significant increase in primary diagnosis by age was among those aged 45-64, which rose 79 percent, while this group also saw the greatest rise in secondary diagnoses, up 183 percent between 2005 and 2014.
The Patient-Centered Outcomes Research Institute has awarded roughly $12 million to the University of Florida in Gainesville for a comparison of intensity-modulated radiation therapy and proton beam therapy for prostate cancer. The agency announced this grant along with several others totaling more than $57 million, including a $6.5 million study to evaluate inoculation with the human papillomavirus in Latino communities.