|Premarket notification (PMN) submissions [510(k)]s for
medical devices are reviewed and processed by the Center
for Devices and Radiological Health (CDRH) within the
FDA. The Office of Device Evaluation (ODE) within CDRH
is responsible for the processing and review of 510(k)s
and providing a decision related to clearance to market
medical devices in the U.S. Within ODE there are six
divisions organized according to medical scientific
disciplines. Each ODE division has a scientific staff
that performs scientific reviews of 510(k)s and other
research (IDE) and marketing applications (PMA). These
individuals are commonly referred to as ODE reviewers.
For the most part, it is their recommendation that
determines whether a new device is substantially
equivalent (SE) or not substantially equivalent (NSE).
The following is a description of how 510(k)s are
processed and reviewed by ODE and the 510(k) programs
that affect this process.
FDA 510(k) Legal and Statutory Consultancy
Prinsip Mahir helps medical device companies to get
their products into the US market. One of the first
steps for medical device companies who manufacture Class
2 device (for which a predicate device exists) is to
file a Pre-market Notification with the Food and Drug
Administration, also known as a FDA 510k application.
Our FDA 510(k) submission and preparation services
- Research and review similar predicate devices already
legally marketed in the US
- Contact the FDA Office of Device Evaluation to determine
any requirements for their review of this product
- Assist in the preparation of the FDA 510 (k) submission
- Submit the FDA 510(k) application (or amendment) to the
- Assist with the preparation of a response if the FDA has
questions or requires additional information
- Act as official correspondent on the application and
remain accessible to the FDA for future discussions
regarding the 510k submission
- Monitor the progress of the FDA 510 (k) through the FDA
review process and supply you with periodic updates
- Prepare the Safety and Efficiency summary
- Provide unlimited phone consultation during the FDA
510(k) application project
Who must submit a FDA 510(k) Pre-market Notification?
- Manufacturers or importer/exporters introducing a new
device (with predicate device) to the US market.
- Manufacturers introducing a new finished device to the
US market. If you manufacturer a component, you do not
need to file a FDA 510(k) unless the component is also
sold as a replacement part.
- Specification developers that design a device and have
it manufactured by another company for eventual sale in
- Companies that are proposing a significantly different
design or different Intended Use for a product that is
already sold in the US.
- Repackagers or relabelers of devices. However, this only
applies is you are significantly changing labels,
manuals, warnings, instructions, etc.
Let Prinsip Mahir's team of experienced medical device
professionals assist you in the preparation of your FDA