Oriel STAT A MATRIX’s experience helps get devices approved quicker, more efficiently, and with greater chance of success.
Oriel STAT A MATRIX assists medical device companies from around the world seeking FDA approval to sell their products in the United States.
Oriel STAT A MATRIX will help you during the 510(k) submission process by:
- Performing a 510(k) assessment to identify or confirm the most appropriate predicate device(s)
- Developing and preparing a written argument for “substantial equivalence” that will compare your device to a predicate device(s)
- Identifying any applicable FDA Guidance Documents
- Communicating directly with FDA staff to identify any special requirements that may impact the review of your 510(k), if necessary
- Preparing and submitting the 510(k) document to the FDA
- Coordinating and communications and negotiations with the FDA reviewer, and preparing responses to the FDA questions if necessary
In addition to directed consulting to to help your organization effectively and efficiently obtain US FDA 510(k) clearance for your medical device, our training course, 510(k) Process for Medical Devices, will help you understand the best way to get your approval to market in the U.S., what is needed to complete the 510(k) process, and when a 510(k) must be submitted.
510(k) Submissions
One of the first steps for medical device companies who manufacture Class 2 medical devices (and a small number of Class 1 and 3 devices) is to file a Premarket Notification, also known as a FDA 510(k) submission, with the Food and Drug Administration.
A 510(k) submission 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 preamarket approaval (PMA).
In general, information contained in a 510(k) includes a description of the device, clinical and preclinical/non-clinical 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.
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 InVitro Diagnostic Device Evaluation and Safety (OICVD) 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 US. Typically this FDA decision is made within 90 days.
Who must submit a FDA 510(k) Premarket Notification?
In general, manufacturers introducing Class 2 medical devices to the U.S. market must submit an FDA 510(k). A 510(k) is also required for manufacturers that are changing the intended use of their medical device, or changing the technology of a cleared device in such a way that it may significantly affect its safety or effectiveness.
Learn more about 510(k) Submissions and FDA Compliance