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/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.
Aptiv Solutions will help you during the 510k submission process by:
- Performing a 510k 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 any communications and negotiations with the FDA reviewer, and preparing responses to FDA questions, if necessary