510 (k) & PMA
A company that wishes to sell a medical device in the United States, in most cases, must submit a Premarket Notification [510(k)] to the FDA. This submission is referred to in Section 510(k) of 21 CFR (Code of Federal Regulations) Part 801.
A 510(k) is a submission to the FDA which illustrates for the FDA how a product is similar to a product that is already legally marketed. When the FDA agrees that the new product is substantially equivalent, the device can then be marketed legally.
Regulatory Specialists, Inc. has years of experience which is combined with a speedy and successful track record of submitting 510(k)'s to the FDA. Assistance with 510(k) submissions can take several forms. Some clients prefer that we conduct the entire submission. Others request guidance while they perform a majority of the submission procedures themselves. Regulatory Specialists, Inc. is flexible and can help each type of client according to their specific needs.
Medical devices that are deemed higher risk are placed in a Class III by the FDA. 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. Due to the level of risk associated with Class III devices, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing clearance. PMA is the most stringent type of device marketing application required by FDA.