Practical, plain-English guides written for lean device teams.
Wondering which FDA pathway is right for your medical device? This article breaks down the key differences between 510(k), PMA, and De Novo — so you can find the clearest route to market for your device.
Before a medical device can reach patients, it must pass a rigorous battery of preclinical tests to ensure safety and efficacy. This article breaks down the five essential evaluations, from biocompatibility to electrical safety, that manufacturers need to complete before pursuing regulatory approval.
Bringing a medical device to market through the FDA 510(k) pathway requires careful planning — from selecting the right predicate device to compiling documentation and testing data. Prime Path's latest guide walks through each step to help you avoid common pitfalls and move toward clearance with confidence.
Animal studies for medical devices can add cost and time with limited value. Bench testing and biocompatibility standards often provide enough safety evidence to reach first-in-human faster.
Correctly classifying your medical device is key to a smooth FDA approval process. Choosing the right classification at the start of the process helps streamline regulatory requirements.
In the medical device industry, ensuring product safety, effectiveness, and compliance with regulatory standards is paramount.
A 510(k) is a marketing submission to the FDA made by a manufacturer to demonstrate that a new device is substantially equivalent to an existing "predicate device."
Whether you're planning your first 510(k) or scaling to commercialization, let's talk about what you actually need.
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