FDA Updates

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2020. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical […]

The FDA plays an important role in the recall process, closely overseeing FDA-regulated companies during their voluntary recalls to help ensure public health is protected.

Artificial intelligence and machine learning have the potential to fundamentally transform the delivery of health care. As technology and science advance, we can expect to see earlier disease detection, more accurate diagnosis, more targeted therapies and significant improvements in personalized medicine. The ability of artificial intelligence and machine learning software to learn from real-world feedback […]

The FDA has issued a draft guidance regarding how it will implement uniform processes and standards that are applicable to inspections (other than for-cause) of foreign and domestic medical device establishments.

A critical focus for the FDA is preventing and mitigating potential medical product shortages. As part of these efforts, we’re taking steps to address potential medical device shortages due to the recent closure of a large sterilization facility in Illinois. We’re working to ensure that safe and effective sterilization of medical devices continues and hospitals, health care providers and patients have access to critical devices.

Spurring innovation to develop safer, more effective devices is key to improving patient safety.

In April 2018, the U.S. Food and Drug Admnistriation (FDA) issued a Medical Device Safety Action Plan, in which the Agency committed to strengthen and modernize its 510(k) program.

In a statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., director of the center for devices and radiological health, an update on the 510(k) program was addressed.

The intent of this public workshop is to publicly discuss the distinction between medical device servicing and remanufacturing activities to better inform the development of a future draft guidance.

As part of the Administration’s ongoing efforts to strengthen cybersecurity in health care, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2020. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical […]

The FDA plays an important role in the recall process, closely overseeing FDA-regulated companies during their voluntary recalls to help ensure public health is protected.

Artificial intelligence and machine learning have the potential to fundamentally transform the delivery of health care. As technology and science advance, we can expect to see earlier disease detection, more accurate diagnosis, more targeted therapies and significant improvements in personalized medicine. The ability of artificial intelligence and machine learning software to learn from real-world feedback […]

The FDA has issued a draft guidance regarding how it will implement uniform processes and standards that are applicable to inspections (other than for-cause) of foreign and domestic medical device establishments.

A critical focus for the FDA is preventing and mitigating potential medical product shortages. As part of these efforts, we’re taking steps to address potential medical device shortages due to the recent closure of a large sterilization facility in Illinois. We’re working to ensure that safe and effective sterilization of medical devices continues and hospitals, health care providers and patients have access to critical devices.

Spurring innovation to develop safer, more effective devices is key to improving patient safety.

In April 2018, the U.S. Food and Drug Admnistriation (FDA) issued a Medical Device Safety Action Plan, in which the Agency committed to strengthen and modernize its 510(k) program.

In a statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., director of the center for devices and radiological health, an update on the 510(k) program was addressed.

The intent of this public workshop is to publicly discuss the distinction between medical device servicing and remanufacturing activities to better inform the development of a future draft guidance.

As part of the Administration’s ongoing efforts to strengthen cybersecurity in health care, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.