Medical Devices Submissions

A 510(k) is a premarket 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.

Krystol Consulting 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) 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.

An Investigational Device Exemption (IDE) allows a medical device to be used in a clinical study for the purpose of collecting 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 prior to 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 working with you to prepare and submit a complete IDE application.

Clinical evaluation of an unapproved device requires:

• An investigational plan approved by an institutional review board (IRB)
• Informed consent from all patients
• Labeling stating that the device is for investigational use only
• Monitoring of the study
• Intended use, and
• Required records and reports

We are the expert you need. We will assist you in the development and submission of a complete IDE application, maximizing the likelihood of FDA approval.