The U.S. FDA issued a May 9 warning letter to Cue Health Inc., of San Diego, following what may have been a routine inspection, but the inspection disclosed that the company had made changes to a COVID test that was granted market access via the emergency use authorization program.

The U.S. FDA has taken off the gloves when it comes to device warning letters. One recent example is the April 3 warning letter to Bioptimal International Ltd., of Shenzen, China, which did not score well with the agency on routine good manufacturing practices. Perhaps more conspicuous was that the company was selling catheters that had undergone significant changes without a new regulatory filing – a seemingly common theme in recent FDA device warning letters.

Route 92 Medical Inc., of San Mateo, Calif., reported a class I recall of nearly 1,000 microcatheters because of reports of separation of the distal tip of the catheter, which is associated with two injuries and one reported death. The company indicated that the problematic catheters had been manufactured by an unidentified contract supplier, once again highlightingthe hazards of a failure to properly oversee the contract manufacture of critical medical devices.

The U.S. FDA’s final rule for lab-developed tests was a long time in coming even if the agency shorted the public comment period for the draft rule, and the final rule makes several major concessions about circumstances in which the agency would exercise enforcement discretion.

The U.S. FDA finalized a guidance for third-party servicing of medical devices, which helps to clarify the distinction between servicing and remanufacturing of a device. However, the most significant change from the draft guidance is that the agency openly declared that it will inspect these independent services organizations, a dramatic shift from the agency’s previous formal stance on these entities.

It’s no surprise to hear that industry’s view of a device’s inherent risk differs from that of the U.S. FDA, a disparity that came to surface in a new citizen petition from Metaltronica SpA of Pomezia, Italy. The company petitioned the agency to down-classify digital breast tomosynthesis system to class II, a move that would align the risk classification with full-field digital mammography and ease the premarket path for future digital breast tomosynthesis applications.

In a May 8 Senate hearing, U.S. FDA commissioner Bob Califf described the agency’s advisory committee process as a useful source of information, but Califf reassured members of the Senate that the FDA is not intent in doing away with advisory hearing votes altogether.

The U.S. FDA and industry have been in scramble mode for some time to address the Environmental Protection Agency’s actions on ethylene oxide, but some manufacturers must also deal with other regulators’ perceptions of what constitutes an acceptable method of sterilization.

Mexico’s Federal Commission for Protection Against Sanitary Risk (COFEPRIS) has released a draft proposal that would overhaul the 2008 version of the rule for device labeling, a document that includes several key proposed reforms.