Submissions for Pre-Market Approval

Medical devices are required to undergo FDA review and approval before being marketed for sale in the United States. In order to achieve this approval, the appropriate application(s) must be submitted to the Agency. The applicable application and regulatory requirements vary depending on the device's classification. As such, the successful classification of your device is imperative.

Our team can help you determine the correct classification, prepare your  go to market regulatory roadmap, and facilitate the completion of your application for marketing approval from regulators.

513(g) Request for Information

According to section 513(g) of the FD&C Act, device manufacturers may submit a written request to obtain the Agency's views regarding device classification and the regulatory requirements applicable to their device.

513(g) requests must be submitted to the FDA in writing and are appropriate in situations where the device manufacturer can't easily determine which class their device fits into and would like to confirm their decision with the FDA. These requests allow manufacturers to obtain additional feedback from the Agency and help sponsors determine the best regulatory pathway for their device.

As with any FDA submission, completing a 513(g) Request for Information is a challenging task and should be completed by a seasoned professional. Zi-Medical can help you determine the best classification for your device, as well as assist in the development and submission of a 513(g) Request for Information. We will work with you to ensure your request is complete and contains all required information, which includes:

  • Cover letter
  • Description of the device
  • Description of what the device is to be used for
  • An investigational plan approved by an institutional review board (IRB)As applicable, any labeling or promotional material of a similar, legally marketed device (if available)

510(k) (Pre-Market Notification)

A 510(k) is a pre-market submission which demonstrates that the device in question is substantially equivalent to a legally marketed medical device and is not subject to a PMA. 510(k) submissions are the most common medical device submission, and FDA-clearance of this application is required before applicable devices can be marketed for sale in the United States.

Zi-Medical has substantial experience developing and submitting 510(k) applications. We have compiled hundreds of 510(k) submissions over the last 35 years. We have a proven track record of success with the FDA and are highly qualified to assist you through the submission process.

Premarket Approval (PMA)

Premarket Approval (PMA) is the regulatory and scientific process used by the FDA to review and evaluate the safety and effectiveness of certain Class III medical devices. Medical devices that are considered high-risk and must obtain an approved PMA from the FDA before the device can be marketed for sale in the United States.

PMA is the most rigorous of all the device marketing applications, and FDA approval is based on the scientific evidence presented in the submission to demonstrate that the device is safe and effective for its intended use(s). Developing a PMA application is extremely complex and time consuming. Due to the Agency's requirement that sponsors provide clinical evidence of the device's safety and effectiveness, developing a successful application requires a significant amount of planning, preparation, and resources. Getting the submission right the first time is critical to the sale of your device, and we can help you do just that.

We work with you through every step of the PMA process. Together we will compile an application that is ready for review by the FDA.

De Novo Request

Wondering whether the De Novo pathway is right for your medical device? You're not alone, but we're here to help. Depending on how you answer the following questions, a de novo submission may be the best option for your device:

  1. Is your product a novel medical device?
  2. Does your device present a low or moderate risk profile?
  3. Do any predicate devices exist?

The De Novo process provides a way to classify low to moderate-risk, novel medical devices. If you have a risk-based strategy and a De Novo determination, it is possible for you to receive approval for your novel medical device without going through the costly and time-consuming PMA process.

However, obtaining a De Novo determination is dependent on your ability to present the general controls or general and special controls which provide reasonable assurance of the safety and effectiveness of the device. De Novo determinations are made by the FDA on a case by case basis, but Zi-Medical can help you get there. We will assist you through the entire submission process, making sure your application contains the most appropriate and relevant information.

Submitting a De Novo request can be difficult and confusing, presenting various roadblocks along the way. We have what it takes to help you overcome those barriers and compile a complete and error-free submission.

Humanitarian Use Device/Humanitarian Device Exemption

A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects less than 8,000 people in the U.S. each year. In order to receive HUD designation from the FDA, various data and documentation must be presented to prove that the device meets the standards required for a HUD designation.

Once the FDA has granted the HUD designation, the sponsor may then develop and submit a Humanitarian Device Exemption (HDE) marketing application. Obtaining FDA approval for these devices can be difficult for even the most seasoned experts because it is dependent on the ability to find and present the right documentation and data. Seeking the assistance of a regulatory consultant is your best bet when preparing a marketing application. Zi-Medical is qualified to assist you with all facets of drug and device development and can help you achieve successful interactions with the FDA. 

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To learn more about how Zi-Medical can help you successfully complete FDA Submissions for your medical devices, IVDs and other medical products, CONTACT US TODAY FOR YOUR FREE CONSULTATION