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Medical devices, especially those from PACS vendors, often classify as "Class II" which means that filing with the FDA is required prior to selling your product in the US. OTech is an independent agency and specializes in filings for PACS and related devices. We have done many filings (see attached list) for several companies, both from within as well as outside the US, and always been able to achieve the filing approval within the allotted timeframe. We help you with this process through:
- Determine what classification your device falls under so that the appropriate rules for filing etc. can be applied.
- Prepare and Submit All Regulatory Filings - 510(k) documentation, Site Registration, and Device Listing.
A typical scenario for filing is as follows:
- We determine the device classification based on the product features and specifications as provided by the manufacturer. Only Class II devices require a 510(k) filing. Note that it is not always perfectly clear what classification a device belongs with, there are some "grey area's" and in some cases it is determined by way precedence, i.e. if another manufacturer has gotten a clearance for a certain product in the past, it is very likely that this is required for the vendor's product. In case of doubt, we would consult with the FDA to ask their opinion. Assuming there is no question, this takes a few days at the most, if we have to consult with the FDA it might take a few weeks.
- Assuming it is Class 2, we provide the client with a checklist that contains all the documentation that is required, indicating what is the responsibility of the client, and what will be provided by OTech. This includes items such as product specifications, test plans, user documentation (client) as well as hazard analysis, indications of use statement (consultant).
- The client indicates what documentation is available. These documents are sent to our consultants and reviewed. Conference calls and e-mails are frequent. If there is documentation missing or incomplete, we will provide examples and templates that can be used by client as basis for their processes to be implemented and accompanying documentation. This process can take from as short as one month, if the organization is committed and dedicated to the process to up to a year. In our experience,, the average time for an organization to make the necessary changes and generate proper documentation seems to be about three to four months.
- After we received all the information, it takes us two solid weeks to put the package together and we send in the paperwork.
- The FDA will review the submitted paperwork, which takes less than 90 days. Our recent turn-around time for this period has been about 70 days.
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