The center is proposing that Philips repair, replace or refund recalled devices manufactured after November 2015.
The catheter is part of the company’s transcatheter pulmonary valve system.
FDA has issued a safety communication to alert patients and healthcare providers about the dangers of inappropriate use of NIPS tests.
With the ever-increasing adoption of connected devices, the agency is emphasizing the need for effective cybersecurity.
The total $8.4 billion fiscal year 2023 budget request is 34% higher than the agency’s 2022 appropriated funding level.
New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.
The agency is urging manufacturers to not only have recall policies in place before a recall is necessary, but to also act quickly in initiating a recall when public health is at risk.
Thus far, the company has received 51 reports of serious injury and three reports of patient death over five years.
Effective February 7, the agency will conduct inspections across all commodities, as well as mission-critical foreign and domestic inspections.
The Class I recall affects more than 95,000 devices in the United States.