This week at FDA: Medtronic MiniMed problems; Device classification flurry

Regulatory NewsRegulatory News | 17 December 2021 |  By 

Welcome to 2021’s last issue of This Week at FDA. This week saw a year-end flurry of device classifications; we are also sharing news of three noteworthy device warning letters and a citizen petition response that closes with FDA’s referring a firm to the Federal Trade Commission (FTC) for anticompetitive practices. 
RAPS offices are closed 23 December – 2 January. Regulatory Focus will resume publication on 3 January. From our team to you, our valued readers, best wishes for a restful and joyous holiday season and a healthy and prosperous 2022. 
Device news
Continuing a weeks-long run of activity, 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 nonimplanted nerve stimulator for functional abdominal pain relief, a manual percutaneous surgical set assembled in the abdomen, and a traumatic brain injury eye movement assessment aid
The Center for Devices and Radiological Health (CDRH) announced today that some devices may be affected by a cybersecurity vulnerability in the software library of some versions of Apache’s Log4j. For versions 2.0-beta9 through 2.14.1, device firms and users should know that the problem may interfere with login and access to some devices, and that a remote user could even hack into a device, although no such events have been reported to FDA to date. “As this is an ongoing and still evolving issue, we also recommend continued vigilance and response to ensure medical devices are appropriately secured,” wrote CDRH in the notice.
Medtronic announced this week that its diabetes division received a warning letter from FDA for ongoing quality management issues at its Northridge, CA facility, which contributes to the manufacture of two of Medtronic’s MiniMed insulin pumps. The letter’s findings came from a July inspection that followed earlier recalls of an insulin infusion pump and remote controller devices. The letter is not yet available on FDA’s website.  
Another device firm was warned this week for failure to maintain complaint files and follow up appropriately on complaints it had received. One such communication reported that the DeVilbiss oxygen concentrator being used in a patient’s home was “smoking and too hot to touch.” Another device was observed to be hot enough to melt portions of the case. In testing, the devices’ compressors consistently ran above recommended temperatures.
Dental Technologies Inc. received a warning letter for current good manufacturing practice (CGMP) violations. Inspectors found that although a sample of the firms’ Paroex 0.12% chlorhexidine oral rinse grew Burkholderia cepacia complex in quantities too numerous to count on an aerobic plate. Other products also failed microbiological testing, growing Pseudomonas aeruginosa. Among other observations, FDA informed the firm that “your cleaning program was deficient.” 
As we went to press last Friday, Brainsgate was before an FDA advisory committee with its neurostimulation device for stroke. Committee members agreed the device was safe, but could not find sufficient evidence of efficacy to support a thumbs up vote. 

Drug and biologic updates
FDA announced this week that it is exercising enforcement discretion with the clozapine REMS, citing long wait times and high call volumes that are impeding patient access to the antipsychotic. The agency clarified that it does not intend to object to dispensing or shipping of clozapine, even if all REMS requirements are not met. Today we also cover FDA’s adjustment of the mifepristone REMS to remove permanently the requirement for in-person dispensing of the chemical abortion drug. 
Acceleron, the recipient of a letter from FDA warning it of non-compliance with FDAAA clinical trial reporting requirements, has now come into compliance, according to FDA’s assessment in this letter, posted this week. 
A new biosimilars curriculum aimed at health care trainees made its debut today, with a landing page hosted by the Center for Biologics Evaluation and Research (CBER). Slide decks, videos, and information sheets have an accompanying teaching resource guide, all aimed at students in medical, PA, nursing, and pharmacy professional degree programs. Low prescriber knowledge and awareness are frequently cited barriers to biosimilar uptake. 

FDA responded this week to to Par Sterile’s citizen petition asking the agency not to approve any future or pending applications for generic vasopressin; the firm had claimed that Eagle’s vasopressin formulation would be prone to an “upward drift” of pH. FDA not only responded that the petitioner provided no evidence in support of the “upward drift” claim, but also noted that the petition “appears to have been submitted with the primary purpose of delaying approval” of Eagle’s application for generic vasopressin. In a tartly worded closing paragraph, the agency notes that it “intends to refer this matter to the FTC, which has the administrative tools and the expertise to investigate and address anticompetitive business practices.”


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