Medical devices are required to undergo review and approval by the Food and Drug Administration (FDA) 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.
ProPharma Group has the knowledge and expertise to help you determine the correct classification for your device and assist with the production and submission of your application.
Medical Device FDA Submission Service Offerings
Investigational Device Exemption (IDE)
An Investigational Device Exemption (IDE) allows a medical device to be used in a clinical study to collect the safety and effectiveness data needed to support a marketing application. Analogous to an Investigational New Drug (IND) application for drugs, manufacturers of significant risk medical devices must obtain IDE approval before initiating a clinical study. However, unlike IND applications, there are no formal, preprinted forms for IDE submissions; only certain information that must be included in the submission. This can make preparing an IDE submission extremely challenging and stressful. We can help ease the stress by working with you to prepare and submit a complete IDE application.
Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. Unless the medical device is exempt, all clinical evaluations of investigational devices must have an approved IDE before the study is initiated. Furthermore, clinical evaluation of an unapproved device requires:
- An investigational plan approved by an institutional review board (IRB)
- If the study involves a significant risk device, the investigational plan must also be approved by the FDA
- Informed consent from all patients
- Labeling stating that the device is for investigational use only
- Monitoring of the study
- Intended use
- Required records and reports
There are many additional requirements involved in obtaining IDE approval from the FDA. Navigating this landscape can be tricky and requires the knowledge and skill of an expert. ProPharma Group has the experts you need. We will help you develop and submit a complete IDE application, maximizing the likelihood of FDA approval.
513(g) Request for Information
According to section 513(g) of the Federal Food, Drug & Cosmetic (FD&C) Act, medical 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 cannot easily determine which class their medical 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 medical 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. ProPharma Group can help you determine the best classification for your device and 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 IRB
- As applicable, any labeling or promotional material of a similar, legally marketed device (if available)
510(k) (Premarket Notification)
A 510(k) is a premarket submission, which demonstrates that the medical device in question is substantially equivalent to a legally marketed medical device and is not subject to a Premarket Approval (PMA). 510(k) submissions are the most common medical device submission, and the FDA-clearance of this application is required before applicable devices can be marketed for sale in the United States.
ProPharma Group has substantial experience in developing and submitting 510(k) applications. We have compiled hundreds of 510(k) submissions over the last three decades. 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 FDA’s regulatory and scientific process to review and evaluate the safety and effectiveness of certain Class III medical devices. Medical devices considered high-risk 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 medical device marketing applications. 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 your medical device’s success, 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 Requests
Wondering whether the De Novo pathway is right for your medical device? You’re not alone, but ProPharma Group is here to help. Depending on how you answer the following questions, a De Novo submission may be the best option for your device:
- Is your product a novel medical device?
- Does your device present a low or moderate risk profile?
- 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 depends on your ability to present the general controls or general and special controls that provide reasonable assurance of the device’s safety and effectiveness. The FDA makes De Novo determinations on a case by case basis, but ProPharma Group can help you get there. We will assist you through the entire submission process, ensuring 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 (HUD)/Humanitarian Device Exemption (HDE)
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 medical 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 professionals because it depends 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. ProPharma Group is qualified to assist you with all facets of drug and medical device development and help you achieve successful interactions with the FDA.