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After months of delay, the FDA and the device industry have reached an agreement in principle on the agency’s commitments for the fifth iteration of the Medical Device User Fee Act (MDUFA) – for fiscal years 2023 to 2027 — but the two sides are still working out details of a commitment letter that was due to Congress by Jan. 15. Read More
In a rare move by the FDA, the agency ordered Philips Respironics to notify patients and other customers of the company’s June 14, 2021, recall of certain models of its ventilators, continuous positive airway pressure (CPAP) and bilevel positive-airway pressure (BiPAP) machines. Read More
Whether a company is primarily a drug manufacturer or a device manufacturer, if it starts making combination products, it will have new additions to its quality management system (QMS) and will “need to learn to speak the language for both sides of the combination product,” according to a former FDA official. Read More
A majority of “smart” infusion pumps are vulnerable to hacking, in many cases because of software flaws that have long been known, according to a report by Palo Alto Networks, a Santa Clara, Calif.-based cybersecurity company. Read More
The FDA has issued a warning letter to Wickimed Medical Equipment Manufacturing for violations of good manufacturing practices (GMP) in making its sterile single-use disposable electrodes. Read More
CardioQuip of College Station, Tex., has received a warning letter from the FDA for making changes to its cardiac heater-cooler without notifying or receiving permission from the FDA. Read More
European device trade association MedTech Europe applauded the European Commission’s Feb. 23 publication of the Data Act, a broad-gauge regulation on data privacy, but it called on the commission to clarify the connections between the proposed legislation and existing device regulations. Read More
Various supply chain resilience measures are needed to ensure U.S. device production before the next pandemic or other natural disaster, a National Academy of Sciences, Engineering and Medicine (NASEM) expert panel advised in a new report. Read More
The FDA should consider broadening the scope of its draft guidance, “Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology,” device manufacturers said in written comments to the agency on the draft, which was released for comment on Dec. 23, 2021. Read More
The FDA should go ahead with its plans to overhaul its Quality System Regulation (QSR) to harmonize it with the International Organization for Standardization’s ISO 13485 standard, but should give device manufacturers more than one year to implement the revised regulation, industry speakers said at a meeting of the agency’s Device Good Manufacturing Practice Advisory Committee on Wednesday. Read More
To clarify the FDA’s recommendations on quickly and effectively removing potentially harmful drugs and devices from the market, the agency has published a final guidance focused on recall readiness. Read More