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Which FDA Pathway is Right for Your Medical Device?

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.

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Top Preclinical Testing for Medical Device Approval: What You Need to Know

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.

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Step-by-Step: How to Prepare a Successful 510(k) Submission

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.

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Do You Really Need Animal Studies for a Medical Device?

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.

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A Complete Guide to FDA Medical Device Classification

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.

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