Frequently Asked Questions
How long will it take to get my 510K cleared?
The short answer is that the review period for the FDA, including any response time for the manufacturer, is about nine months. However, that timeline can be increased if your submission package is incomplete, or decreased if your response time to the FDA is quick. We strive to help companies provide a complete submission package for swift review acceptance at the FDA, and we work to respond quickly to FDA questions.
What role will you take in my submissions?
We can be as involved in your submission as you would like. We can draft all submission materials, review your test reports, interface with regulatory agencies and notified bodies, and be present for your audits and inspections. We can lead your submissions or support your team. Our goal is to fit with your needs.
Can you help me with the testing requirements for a submission?
We have a strong network of consultants and laboratories that we work with directly and refer clients to in order to address their testing needs. This includes biocompatibility, engineering, IEC testing, pre-clinical testing, and clinical trial development and reporting.
When should I engage with a regulatory consultant for my submissions?
The earlier the better! We can help determine your regulatory pathway, testing requirements, documentation needs, and allowable indications for use. These strategic decisions can be crucial in early design phases. However, if you’re far along and just catching up to your device’s regulatory requirements, we’re here to help get you on track.Once I receive a 510K clearance, are there other things I should be thinking about?
Yes. Once you are ready to be commercial in the United States you will need to register your company as an establishment in the FDA database and list your device in that same database. We can guide you through this process. In addition, you will need be subject to FDA inspection once you start selling in the United States and will require to have a Quality Management System (QMS). We can support your development of this systemAm I required to conduct an internal audit of my company?
Internal audits are required and are typically conducted on an annual basis. It may be easier to outsource this process rather than trying to conduct these audits with your own staff. We have two certified lead auditors on our team with extensive audit experience who can conduct these audits for you. We can conduct the audits on-site or remotely.If I want to get my device licensed to sell in Canada are there any special requirements?
Health Canada requires that the submitting company hold a Medical Device Single Audit Program certification known as MDSAP. This does require engaging an outside agency called a Notified Body to audit your company and issue the certification. We have extensive experience in this process and can perform a Gap Analysis of your quality system as well as help you develop the correct procedures.
If I have an FDA inspection and the FDA identifies problems, what should I do?
The FDA may issue you a report called a “483” during an inspection. This is a report of deficiencies in your organization in meeting the FDA regulations. If this happens you will be required to respond within 15 days of your plan to correct the deficiencies and failure to do so may lead to enforcement action from the FDA. If this happens you may want to seek outside help in formulating your response. We can support this effort and help your company formulate a solid plan for responding to FDA and avoiding future enforcement actions.
How do I know if I need a clinical trial?
Some devices do not require clinical trials, and can gain FDA approval through the 510k pathway. There are other product that require a clinical trial in order to seek approval. We can help you navigate the FDA regulations, get FDA feedback and determine if a trial is needed.
I have been told that I need to conduct a clinical trial, now what?
If your device requires a clinical trial, we are here to help. We can assist with protocol preparation, study site selection, IRB approvals, trial monitoring and more. Whether you need help from the ground up, or just some sanity checks, our clinical team can support you.
What are the expenses involved in a clinical trial?
The short answer is: It depends. Planning and executing a clinical trial comes with expenses. You will require an IRB approval in order to conduct your trial in the United States. You will also need to hire and pay a principal investigator, and prices can vary depending on the size of your study. There are often expenses that are unexpected, such as requiring a specialized piece of equipment for the trial. We will help you understand what the financial requirements are for planning and executing a successful trial, and work with our large network of vendors to ensure you get the best service and keep costs down.