This Week at the FDA: Medtronic MiniMed Problems; The device classification wave
Welcome to the final 2021 issue of This Week at FDA. This week saw a flurry of year-end device classifications; we also share news of three notable device warning letters and a response to a citizen petition that ends with the FDA referring a company to the Federal Trade Commission (FTC) for anticompetitive practices.
The RAPS offices are closed from December 23 to January 2. Regulatory guidance will resume publication on January 3. From our team to you, dear readers, our best wishes for a restful and joyful holiday season and a healthy and prosperous 2022.
Continuing a week of activities, the FDA issued orders classifying more medical devices this week, including a temporary coil embolization assist device, a pressure ulcer management tool, spinal spheres for use in intervertebral fusion procedures, an endoscopic transhepatic venous access needle, a non-implanted nerve stimulator for the functional relief of abdominal pain, a manual percutaneous surgical assembly assembled in the abdomen, and an aid in eye movement assessment of traumatic brain injury.
The Center for Devices and Radiological Health (CDRH) today announced that some devices may be affected by a cybersecurity vulnerability in the software library of certain versions of Apache Log4j. For versions 2.0-beta9 through 2.14.1, device manufacturers and users should be aware that the issue may interfere with logging in and accessing certain devices, and a remote user may even hack a device, though that no such event has been reported to the FDA. nowadays. “As this is an ongoing and ever-evolving issue, we also recommend continued vigilance and response to ensure medical devices are properly secured,” CDRH wrote in the advisory.
Medtronic announced this week that its diabetes division had received a warning letter from the FDA over ongoing quality management issues at its Northridge, Calif. plant, which helps manufacture two of the insulin pumps. MiniMed from Medtronic. The letter’s findings came from a July inspection that followed earlier recalls of an insulin infusion pump and remote control devices. The letter is not yet available on the FDA website.
Another device company was tipped off this week for failing to keep complaint records and properly track complaints it received. One such communication reported that the DeVilbiss oxygen concentrator used in a patient’s home was “smoky and too hot to touch”. Another device was observed to be hot enough to melt parts of the case. During testing, the compressors of the devices consistently operated above the recommended temperatures.
Dental Technologies Inc. has received a warning letter for violating current Good Manufacturing Practices (CGMP). Inspectors found that although a sample of the companies Paroex 0.12% chlorhexidine mouthwash had increased Burkholderia cepacia complex in quantities too numerous to count on an aerobic plate. Other products have also failed microbiological tests, Pseudomonas aeruginosa. Among other observations, the FDA informed the company that “your cleaning program was deficient.”
As we went to press last Friday, Brainsgate was before an FDA advisory panel with its stroke neurostimulation device. Committee members agreed that the device was safe, but could not find enough evidence of effectiveness to support a positive vote.
Drug and Biologics Updates
The FDA announced this week that it was exercising its discretion with clozapine’s REMS, citing long wait times and high call volumes that impede patient access to the antipsychotic. The agency clarified that it does not intend to object to the distribution or shipment of clozapine, even if all REMS requirements are not met. Today, we are also covering the FDA’s adjustment of mifepristone’s REMS to permanently remove the requirement for in-person dispensing of the chemical abortion drug.
Acceleron, the recipient of a letter from the FDA warning it of non-compliance with FDAAA clinical trial reporting requirements, is now in compliance, according to the FDA’s assessment in that letter, published this week.
A new biosimilars program for healthcare trainees debuted today, with a homepage hosted by the Center for Biologics Research and Evaluation (CBER). The slides, videos, and fact sheets are accompanied by an educational resource guide, all aimed at students of professional degree programs in medicine, medicine, nursing, and pharmacy. Insufficient knowledge and awareness among prescribers are frequently cited barriers to the uptake of biosimilars.
The FDA responded this week to Par Sterile’s citizen petition asking the agency not to approve future or pending applications for generic vasopressin; the firm had claimed that Eagle’s vasopressin formulation would be prone to “upward drift” in pH. The FDA not only responded that the petitioner provided no evidence to support the “upward drift” claim, but also noted that the petition “appears to have been submitted for the primary purpose of delaying the ‘approval’ of Eagle’s application for generic vasopressin. In a sharply worded closing paragraph, the agency notes that it “intends to refer this matter to the FTC, which has the administrative tools and expertise to investigate and combat anticompetitive business practices.”
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