510(k) Pre-Market Notification Submission

We will…

  • Evaluate your medical device description and intended use to determine your medical device’s product classification, product code and regulation number

  • https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

  • Identify FDA Recognized Consensus Standards that apply to your product (such as Electrical Safety and Biocompatibility), and any product specific FDA Guidance Documents

  • https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

  • Recommend the optimum predicate device to compare your device’s performance when developing the 510(K)

  • https://www.fda.gov/medical-devices/premarket-notification-510k/how-find-and-effectively-use-predicate-devices

  • Write and assemble your 510(k), including the Executive Summary, Device Description and Substantial Equivalence sections

  • https://www.fda.gov/medical-devices/premarket-notification-510k/how-prepare-traditional-510k

  • 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 will work with you utilizing the pre-submission process with FDA to minimize the potential of a NSE letter.

The 510(k) did not convince the reviewer of substantial equivalence.

We know a successfully written 510(k) presents a coherent and consistent Substantial Equivalence argument for the predicate device throughout the entire 510(k).

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. 

We have conducted pre-submission meetings with FDA and our clients to identify the concerns the FDA may have with the proposed submission.