What data does the company need to provide Vision28 for a 510(k)?
We will perform a Preliminary Regulatory Assessment of your device to verify your device's classification and provide you with a list of required data to support your 510(k). A generalized model may look like this:
Once you have the data, what goes into a 510(k)?
Once you have all of the data needed for a submission, Vision28 will construct a 510(k) submission. The Executive Summary, Device Description, and Substantial Equivalence Discussion are critical to the submission. We use our experience in submitting 510(k)s to assure all comparisons to your predicate lead FDA to only one conclusion: your device is "Substantially Equivalent" to the predicate.
Am I guaranteed 510(k) Clearance?
Unfortunately, no. Each 510(k) reviewer is a different person with different perspectives on what "Substantial Equivalence" means and submitted data must be of extremely high caliber to be accepted. Most 510(k) submissions fail due to weak Substantially Equivalent Discussions and unclear data presentations and conclusions. We will work with you to ensure the most thorough discussion and the highest quality data and data presentation possible to submit.
How much does this cost?
Vision28 takes a three-pronged approach to submit 510(k)s:
From our experience, we know that the act of putting together a 510(k) submission, when these three prongs are of the highest quality and the product does not have features that are new to the predicate device, requires about 70 hours. If we need work to improve your material, additional hours will apply.
We find the best approach to answer this question is to perform a Preliminary Regulatory Assessment (PRA). We analyze the regulatory environment for your product based on your product's intended use, classification name, predicate products, and the status of your Quality System. Using this information, we will determine the best submission strategy for the US market, and we will specify what, when, and where to submit for FDA clearance. We will recommend any further action you may take to expedite your goal of US Market introduction, such as a pre-submission conference call with the FDA. Finally, we will examine your Quality System and recommend any actions you may need. The PRA takes 15 to 20 hours of work to complete. Therefore, our initial estimate would be:
PRA: 15 – 20 hours
510(k): 70 hours
Gaps Identified by PRA: To be determined
Gaps between Predicate and Submitted Product: To be determined
Total Hours: 85 – 90 hours plus time to remediate identified gaps.
How much calendar time will this take?
A calendar schedule is highly dependent on the timeliness and quality of your responses to requests for data, reports, and other information. In general, the project sequence would be:
Once we have a clear path for our Substantial Equivalence arguments and we have high-quality test data and conclusions, Vision28 will require one to two months to complete the 510(k) submission.
If we determine in the PRA analysis that a call with FDA would answer complex predicate or testing questions, that process may add two to three months to the timeline but may save the company from a potentially failed 510(k).
Elements to determine calendar schedule (work may be done in parallel):
PRA 2 weeks
Company Testing To be determined
Quality System Remediation, if required To be determined
Pre-Submission call with FDA, if required 2 – 3 months
Test data and conclusions review and remediation, if required To be determined
510(k) assembly and submission 1 – 2 months
We hope you find this general overview informative. Of course, every client is unique, and we will work with you to determine the fastest path to market for your medical device.