Bring Your FDA Regulated Medical Devices to the US Market with the 510(k) Pathway
A 510(k), formally known as a Premarket Notification, is a technical dossier submission that is required by the Food and Drug Administration (FDA) for qualifying medium-risk medical devices and in vitro diagnostic devices (IVD) to be legally marketed and distributed in the United States. These submissions must demonstrate the device meets product-specific safety and efficacy standards set by US regulatory agencies and prove the device is substantially equivalent to a predicate device (a device that has already been cleared by the agency for commercialization in the US) to be granted market authorization.
Speak to An Expert
Your 510(k) Submission Team
At Accorto, we specialize in helping small to mid-size companies navigate the complex regulatory landscape to bring their FDA-regulated products to market quickly and efficiently.
Industry
Experts
Backed by a collective experience of over 150 years with the FDA across a range of regulated sectors, our team brings an unparalleled depth of knowledge and expertise to your 510(k) submission.
Custom Tailored Solutions
We recognize the unique needs of each client, which is why we customize our approaches to fit your budget and timeline. Our personalized strategies ensure you receive top-tier regulatory services without compromising on your specific goals and resources.
Accelerate Your To-Market Timeline
We understand time to market can critically impact market success for our clients. With our streamlined processes, you’ll experience a faster journey from submission to approval.
Turnkey 510(k) Submission Solutions
Let our team take the complexity out of FDA 510(k) submissions. Our team has decades of experience navigating the intricate FDA medical device regulatory landscape, allowing us to seamlessly guide your product through the appropriate pathway toward market acceptance. From strategy development to application submission, we’re your partners in securing swift approvals and market leadership.
Our 510(k) Solutions Include:
The Right Resources.
The Right Time.
When you choose Accorto for your 510(k) project, you not only gain access to our in-house team of industry experts and technical writers but also our global network of industry partners who are on-call and ready to complete your project’s requirements. From design houses, to contract manufacturers, to clinical research organizations (CRO’s), we have access to the resources you need to achieve success.
All organizations in our network have been hand-selected for their specialized knowledge, state-of-the-art facilities, and track record of delivering exceptional results and our network is constantly expanding, allowing us to keep pace with industry advancements and deliver cutting-edge solutions for our client’s unique projects.
Contact Us
to discuss how Accorto can expedite your medical device’s path to market through the 510(k) pathway today.
