510(k) Submission Contents and Format for Medical Devices
A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3).
Question And Answers
1. Why the concept of 510(k) programme was created?
In order to foster the creation of safe medical devices, Congress passed the Medical Device Amendment to FD&C
act. As a result FDA’s authority was expanded to regulate medical device and created the concept of 510(k)
2. What is a 510(k) Premarket Notification?
Under the section 510(k) of the FD&C Act a manufacturer must submit a 510(k) to FDA at least 90 days before introducing or delivering for introduction, a device into interstate commerce for commercial distribution and must demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA)
3. What is Substantial Equivalence according to 513(i) of FD&C Act?
Substantial Equivalence means with respect to a device being compared to a predicate device that the device has
the same intended use, same technological characteristics, the device is as safe and effective as a legally marketed
4. What is the meaning of "different technological characteristics"?
"Different technological characteristics" means, with respect to a device being compared to a predicate device,
that there is a significant change in the materials, design, energy source or other features of the device from those
of the predicate device.
5. How can the agency limit the use of the device?
When the agency reviewer see there is a potential likelihood of label used they have power to limit the use of
device by making some statement in the labelling.
6. What is the necessary document to be submitted to file a premarket notification under the section 510(k)?
As a part of a submission under section 510(k) respecting a device, the person required to file a premarket
notification under such section shall provide an adequate summary of any information respecting safety and
effectiveness or state that such information will be made available upon request by any person.
7. What are the In vitro diagnostic products?
In vitro diagnostic products are those reagents, instruments and systems intended for use in diagnosis of disease or
other conditions including a determination of the state of health in order to cure, mitigate, treat or prevent
disease or its sequelae.
8. Where the In vitro diagnostic products are used?
In vitro diagnostic products are intended for use in the collection, preparation and examination of specimens taken
from the human body.
9. What is the tradition or abbreviated 510 (k)?
Both demonstrate Substantial Equivalence to another 510(k) device, same intended use and same technological
characteristics. If you have different technological characteristics but you argue that it raises no new or different
question regarding substantial equivalence.
10. What is CLSI?
CLSI refers to Clinical and Laboratory Standard Institute. It is voluntary consciences standard organization with one
voice, one mission and one unique consciences process. It is formerly known as National Comity for Clinical
Laboratory Standards (NCCLS).