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FDA Submissions

Depending upon the classification of your device and your current stage in the medical device development process, there are a variety of medical device submissions that may be required by the FDA.

MDCI will work with your team to review, prepare and submit a "reviewer-friendly" document, designed to effectively address FDA concerns and minimize additional questions. MDCI has prepared and submitted hundreds of successful FDA medical device regulatory documents for U.S. and international clients, including:

• 510(k) Premarket Notifications
• Investigational Device Exemption Applications (IDEs)
• Premarket Approval Applications (PMAs)
• Investigational New Drug Applications (INDs)
• 513(g) Requests for Classification
   

510(k) Premarket Notifications

The majority of medical devices commercialized in the United States require a 510(k) submission, which is used to demonstrate that the medical device is at least as safe and effective, or substantially equivalent, to a predicate device, meaning a device that is legally marketed and is not subject to a PMA

The Center for Devices and Radiological Health (CDRH) within the FDA receives nearly 4,000 510(k) submissions annually. Within CDRH, the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) are responsible for processing and reviewing 510(k)s. Branches within these offices are organized according to medical scientific disciplines and are staffed by FDA reviewers. These reviewers, who are biomedical engineers, physicians, microbiologists, chemists, and other professionals, will determine whether a new medical device is substantially equivalent and can be marketed in the United States. Typically, this FDA decision is made within 90 days.

In general, information contained in a 510k includes a description of the device, clinical and preclinical/nonclinical performance data, device labeling and instructions for use, comparative products and/or standard methods documentation, and, if applicable, a description of any software or firmware used in the medical device.

MDCI will help you to:

• Perform a 510k assessment to identify or confirm the most appropriate predicate device(s)
• Develop and prepare a written argument for "substantial equivalence" that will compare your device to a predicate device(s).
• Identify any applicable FDA Guidance Documents
• Communicate directly with FDA staff to identify any special requirements that may impact the review of your 510(k), if necessary
• Prepare and submit the 510(k) document to the FDA
• Coordinate any communications and negotiations with the FDA reviewer, and prepare responses to FDA questions, if necessary

Investigational Device Exemption Applications (IDEs)

An investigational device exemption (IDE) allows a sponsor to use an uncleared or unapproved medical device in a clinical study to collect safety and effectiveness data to support a 510(k) or PMA submission to the FDA. Sponsors must obtain IDE approval before the study begins. The IDE must be approved by an institutional review board (IRB), and if the device is a "significant risk device", it must also be approved by the FDA. In addition, the sponsor must ensure that all patients in the study provide informed consent, the device under evaluation must be labeled "for investigational use only", the study must be monitored appropriately, and the sponsor must prepare certain required records and reports. An approved IDE allows the device be shipped lawfully for use in the study without complying with other FDA requirements that would apply to devices in commercial distribution.

MDCI will work with you to write, edit and organize your IDE application for presentation to the FDA. Typically, an IDE application includes the following: a detailed description of the device and an explanation of how it works, final reports of prior studies performed on the device, the Investigational Plan (including the protocol, case report forms, informed consent form, investigator agreement, risk analysis, statistical plan, and monitoring procedures), labeling and device labels appropriate for the clinical study, and a summary of manufacturing procedures.

If you have not had previous contact with the FDA or if you are proposing to study new technologies or new uses for existing technologies, MDCI can also provide assistance with pre-IDE activities.

Premarket Approval Applications (PMAs)

Premarket approval (PMA) is the FDA review process to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

A PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. The FDA bases a PMA approval on a determination that the submission contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).

Information contained in a PMA submission typically includes the following: a device description and indications for use, alternative practices and procedures, marketing history, manufacturing information, reference to any performance standard or voluntary standard, results of nonclinical laboratory studies, results of clinical investigations involving human subjects, and copies of all proposed labeling for the device.

FDA regulations provide 180 days to review the PMA and make a determination, but often, the review time is longer. Before approving or denying a PMA, the appropriate FDA advisory committee may review the PMA at a public meeting and provide the FDA with the committee's recommendation on whether the FDA should approve the submission.

MDCI will assist throughout the PMA process to help you to edit and organize the information to be included in your submission , prepare for and participate in any FDA review meetings and advisory committee meetings, if necessary, and assist you in preparing for FDA inspections of your manufacturing facility.

Investigational New Drug Applications (INDs)

Similar to an Investigation Device Exemption (IDE), which is submitted to the FDA prior to beginning clinical trials of a medical device, the Investigational New Drug (IND) application is intended to provide sufficient data to the FDA to demonstrate that it is reasonable to begin clinical tests of a new drug or biologic product on humans. The IND is the means through which the sponsor technically obtains exemption from FDA regulations governing the interstate commerce of drug and biologic products while they are under clinical investigation.

During a new product's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the product exhibits early safety and effectiveness that suggest an opportunity for commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.

The IND is not an application for marketing approval. The IND is a submission in which the sponsor provides a summary of the preclinical testing from in vitro and in vivo methods and a summary of the manufacturing and control methods that will be used to produce the clinical product. The IND also contains the details of the clinical investigation plan.

MDCI helps clients with combination products, such as drug/device and biologic/device applications in which the primary mode of action is either the drug or biologic component, and correspondingly, the FDA Center for Drugs (CDER) or Center for Biologics (CBER) will have primary jurisdiction. MDCI can help clients identify how their particular product will likely be regulated by FDA, and facilitate the preparation of IND documentation for agency review.

513(g) Requests for Classification

Under Section 513(g) of the Food, Drug, & Cosmetic Act (the Act), a person can request a classification decision from the FDA for a new or modified device for which there is no clear classification already available. The FDA’s written guidance, as a result of a 513(g) submission, can be valuable in making decisions about the appropriate regulatory strategy for product commercialization. This guidance is also sometimes useful in discussions with potential distributors, marketing partners, or investors. In addition, all of the elements of the 513(g) may be incorporated into the 510(k) Premarket Notification should the FDA classify the product as a Class II device.