Devices

Software Precertification Program Comments

GE Healthcare says the concept of the FDA software precertification program “maintains FDA’s gold standard in ensuring safety and effectiveness of software medical devices, while providing faster access to market for software devices developed by trusted pre-certified organizations.” The company says that accelerated pathway is crucial in helping support the public health goal of timely access to innovative technologies that improve patient care.

In its comment letter, the company says it isn’t clear whether trusted pre-certified organizations will have the ability to place software medical devices on the market faster than under the current regulatory scheme. It asks FDA to clarify to what extent the “no review” pathway can be implemented in the absence of congressional action and provide clarity on the streamlined review pathway and timelines.

AdvaMed says it applauds FDA for developing the software precertification working model and appreciates the agency’s consideration of the numerous perspectives and comments it received through the docket and from pilot participants and other stakeholders. “The program’s intent, as reflected in the working model, is consistent with that of industry,” it says. The letter includes high-level feedback on sections of the working model and detailed line-by-line comments.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome