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FDA Set Record on Approval of Novel Medical Devices in 2018

Last year, the FDA approved 106 novel medical devices, surpassing the previous record of 99 in 2017.

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Source: Getty Images

By Fred Donovan

- Last year, the FDA approved 106 novel medical devices, surpassing the previous record of 99 in 2017, the agency announced last week.

This milestone marks eight years of steady improvement in novel medical device approvals.

The agency said it strives to balance patient safety with the need to get innovative devices to market.

“The FDA’s focus on both safety and innovation stems from our historic mission to protect and promote public health—to assure that medical devices on the U.S. market are high-quality, safe and effective and to facilitate innovation and assure that patients and providers have timely and continued access to these high-quality, safe and effective devices,” said FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren in a statement.

“Spurring innovation to develop safer, more effective devices is key to improving patient safety. We are equally committed to advancing safe and effective products that can address unmet medical needs to reduce the health effects from disease,” they added.

Source: FDA

The FDA said it has also granted 112 Breakthrough Device Designation requests since the beginning of the program in 2015. Last year, it approved or cleared 9 such requests.

The agency cited a few examples of novel devices that came to market last year:

  • world’s smallest heart valve for newborns;
  • first blood test to evaluate mild traumatic brain injury
  • first mobile medical app to help treat substance abuse disorders
  • technologies using artificial intelligence to detect diabetic retinopathy in adults and for aiding providers in the detection of wrist fractures.
  • first artificial iris approved for use in the United States

The FDA is moving forward with plans to implement the National Evaluation System for Health Technology (NEST), a surveillance and evaluation system operated by a public-private partnership.

This year, the FDA also plans to issue a proposed framework for the Safer Technologies Program (STeP). For this program, the agency will consider how it could apply Breakthrough Device principles and features to products intended to treat or diagnose non-life-threatening diseases or conditions. At the same time, these devices will offer safety innovations that either reduce the occurrence of a serious adverse event or other safety issue, address a known device failure mode or common user error, or provide for significant safety advantages for users.

“Our success in driving better safety and greater innovation depends, in part, on our ability to be innovative. We need to be able to continually adapt our frameworks, try new approaches, and, where necessary, seek new authorities because science does not stand still,” Gottlieb and Shuren observed.

They stressed that it is “vital” for the FDA’s regulatory approach to evolve and modernize in order to safely and efficiently advance progress in digital health and other opportunities with healthcare implications.

“Not only must we keep pace with this complexity and innovation, but we must also stay ahead of the new and evolving risks that can sometimes accompany novel products. We must skate to where the puck will be, and, even better for patients, drive the puck to where it should be. That requires the willingness to embrace and lead change,” they added.

The FDA is continuing to implement its Medical Device Safety Action Plan. In the action plan, the FDA describes steps it is taking in the following areas: establish a medical device patient safety net, explore regulatory options to streamline implementation of postmarket mitigations, spur innovation towards safer medical devices, improve medical device cybersecurity, and integrate the CDRH's premarket and postmarket offices and activities to expand the use of a total product lifecycle approach to device safety.

The CDRH is working to integrating its premarket and postmarket offices to optimize decision making about medical devices. Some of the risks inherent in medical devices are better understood once the devices have been widely distributed to patients and clinicians, the agency explained.


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