FDA Regulations Benefit the Medical Profession and Improve Patient Care

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The U.S. Food and Drug Administration (FDA) branch named the “Center for Devices and Radiologic Health” regulates manufacturers, distributors and importers of medical devices.  Carestream Health follows FDA regulations and guidance relating to the design, manufacture, distribution, servicing and maintenance of its products. In addition, many of Carestream’s products are subject to FDA review for safety and effectiveness prior to receiving permission to market those products in the United States.

FDA  “Center for Devices and Radiologic Health”

The FDA’s “Center for Devices and Radiologic Health” branch regulates manufacturers, distributors and importers of medical devices.

Premarket submissions to the FDA include:

  • Various administrative documents.
  • Evidence that the product performs in a safe and effective manner.
  • In most cases, clinical evidence of the product’s performance must be gathered, analyzed and submitted to demonstrate safety and effectiveness of the device to the FDA reviewer.
  • Evidence that the product was designed and validated for proper performance against its specifications.
  • User documentation to ensure that users of the product are provided with adequate instructions for operating the device.
  • Depending on the level of regulatory control for a particular product, inspection of the manufacturing operation by the FDA may also be required prior to gaining approval to market a device.

Compliance with FDA regulation and guidance is a benefit to our customers and ultimately to the patients whose medical care is aided by the use of our products. Carestream has established and maintains a quality system for the medical devices it manufactures. This quality system consists of procedures and guidelines that are in accordance with the requirements put in place by the FDA. Some requirements apply generally to all devices and some are specific to the types of devices we produce (i.e. radiation emitting devices). The purpose of these requirements is to ensure that every stage of product design, manufacture, distribution, installation and servicing is structured and completed in compliance with processes proven to result in high-quality, safe and effective products.

FDA requirements are not limited to the design, production and sale of the medical device to the customer. As a manufacturer of medical devices, Carestream also maintains established procedures for installing and servicing its products at customer sites. These procedures must be documented, validated and controlled to ensure that the products are properly serviced and maintained.

Procedures are in place to ensure that any complaints or issues reported to us about our products are properly addressed and corrected in a timely manner. Any issues that could impact safety or effectiveness of the device are documented and considered in the ongoing analysis and mitigation of any risks associated with the device.

Carestream is dedicated to ensuring customer satisfaction and improving patient care.  Embracing FDA regulations is one way we continue to provide the medical profession with innovative, well-designed, high-quality products that benefit healthcare providers and the patients they serve.

Do Carestream medical imaging systems aid in the delivery of care at your facility? Are you satisfied with Carestream’s level of service and support? 

Carolyn L. Wagner Regulatory Affairs Manager, X-ray Solutions, CarestreamCarolyn L. Wagner is the Regulatory Affairs Manager for the X-ray Solutions business at Carestream.


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