Evaluate your product’s description and intended use to determine your devices product classification, product code and regulation number
Identify FDA Recognized Consensus Standards that apply to your product (such as Electrical Safety and Biocompatibility), and any product specific FDA Guidance Documents
Recommend the optimum predicate device to compare your device’s performance when developing the 510(K)
Write and assemble your 510(k), including the Executive Summary, Device Description and Substantial Equivalence sections
During 510(k) development, we can provide project management services by coordinating with third party test houses for Consensus Standards testing, reviewing deliverables, and augmenting your resources for developing software design documentation necessary for 510(k) submissions
After you review and approve the 510(k) draft, we will submit it in your behalf to FDA
A Not Substantially Equivalent (NSE) letter will cause market entry delays, additional fees paid to FDA, and additional expenditure for further tests.
We have file many 510(k)s for our clients, without a NSE finding by FDA.
The 510(k) did not convince the reviewer of substantial equivalence.
With over 20 years’ experience writing successful submissions, we know a successfully written 510(k) presents a coherent and consistent Substantial Equivalence argument for the predicate device throughout the entire 510(k).
Inexperienced 510(k) writers may become confused with complex technologies, and may fail to make compelling arguments for substantial equivalence, or worse, may misrepresent your product.
Our 510(k)s include a wide range of complexity in products: reprocessed single use devices, simple mechanical devices, complex motor driven electro-mechanical systems, algorithm driven software imaging systems, 3D-print medical devices, and In Vivo Diagnostic Kits.
FDA 510(k) Reviewers expect specific data, data analysis and conclusions since they review competitors’ 510(k)s. Will your 510(k) measure up?
By making sure we are collecting high quality, necessary data, your business will not spend time and money developing data that will not be adequate or necessary to prove Substantial Equivalence.
Your product is more unique than your competitors, and you are concerned you may not have the right predicate device for your 510k.
Products we have obtained 510(k) clearance have ranged from very obvious predicate devices, to multiple predicates with which to demonstrate Substantial Equivalence.
Your product is unique, and you are not sure 510(k) is the right way to go.
In addition to our 20 years’ experience writing successful submissions, we have conducted pre-submission meetings with FDA and our clients to assure the path you are on will gather the data the FDA requires to find substantial equivalence.