Little Known Methods for FDA Medical Device Approval

Regulations - quality.jpegWe are all well aware of the many processes and regulations that must be adhered to in order to achieve FDA medical device approval. Now the FDA says there are certain methods that may allow for the approval of more medical devices. What specific criteria does the FDA look for? What does it take to ensure that medical devices are safe and effective? A recent article explains. 

In an article posted in Med Device Online Jof Enriquez explores the methods used by regulatory offices to determine whether medical devices meet quality and regulatory requirements. He cites a recent article by the FDA in The New England Journal of Medicine (NEJM) which states that "flexible and alternative means to generate clinical evidence, such as existing registries and computer modeling techniques, could form the basis for approving more medical devices in the future." This is good news for medical instrument companies and medical device manufacturers. 

Medical instrumentation facilities may provide the FDA with clinical data from trials that are randomized, double-blind, or information from controlled drug trials. However, In a viewpoint article, Owen Faris, Ph.D., acting Clinical Trials Director, Office of Device Evaluation, Center for Devices and Radiological Health (CDRH), and Jeffrey Shuren, CDHR Director, explain "for many devices, however, practical limitations related to the device or disease condition require alternative approaches."

Faris and Shuren take a look at the ineffectiveness of blind trials. In their view, the implantation of placebo devices or procedures itself is impractical or unethical. Rather than clinical studies, they suggest alternative data sources to determine the safety and effectiveness of the medical device.

In the article, Faris and Shuren mention "device companies are now using stochastic engineering models to simulate clinical outcomes for 'virtual patients' by modeling a relationship between bench outcomes and clinical end points. This could mean virtual patients, rather than real ones, could be involved in future trials."

It is essential to stay abreast of the evolving Food and Drug Administration (FDA) regulations and requirements when developing and manufacturing complex medical devices that are safe and effective. As a leading medical engineering and manufacturing firm since 1980, KMC Systems has a proven track record of success with FDA medical device approval. We hope that you will leverage our expertise in helping our customers bring groundbreaking, compliant medical instrumentation to market. Our multidisciplined teams of engineering and manufacturing professionals are adept at taking initial concepts thru development and design, and successfully bringing instrumentation to market, all while adhering to quality and regulatory requirements. 

Click here to read the full article by Jof Enriquez in Med Device Online. 

To learn more about KMC Systems' capabilities, click here to download our brochure.

New Call-to-action

Topics: medical device manufacturing, quality assurance