A 510(k) or Premarket Notification is the technical document required by the FDA to prove that the device to be marketed in the United States are as safe and effective, that is, substantially equivalent, to a legally marketed device which is not subject to PMA. A person who apply for 510K clearance must compare their device to similar legally marketed devices and create and support their substantial equivalence claims. The legally marketed devices to which uniformity is drawn is known as “Predicate”.
The Submitter cannot market the device until he receives an order from FDA declaring a device substantially equivalent (SE). Once the device is declared as SE, it can be legally marketed in United States. SE determination will be made within 90 days of submission and also based on the information submitted by the submitter. Substantial equivalence is issued with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics of the device. If FDA found out that the device is not substantially equivalent (SE), the submitter has to resubmit another 510K with new information or request a product classification via De Nova Classification process or to submit a premarket approval application (PMA).
Who needs to submit a 510K
The following are the four categories of 510K submitters to the FDA.
- Domestic manufacturers who introduce a new device to the U.S market. However only finished device manufacturers who manufacture device according to their own specifications needs to submit 510K, whereas the contract manufacturers are not required to submit a 510K.
- Specification developers are required to submit a 510K but not the contract manufacturers.
- Re-packers or Re-labelers may be required to submit 510K if they change the labels or any other operations that affect the condition of the device.
- Foreign manufacturers/exporters who introduce a new device to the U.S market.
All manufacturers, specification developers of Class II and Class III devices and certain Class I devices are required to follow 21 CFR 820 regulations.
Liberty Management Group, a leading FDA consulting group in the United States, provides assistance with preparation and submission of 510K to FDA, US agent service for foreign facilities, medical device establishment registration and listing with FDA.
Sudha S
Regulatory Consultant
Mial : office@libertymanagement.us
fda certificate https://www.fdahelp.us/certificate-of-fda-registration.html
register with FDA https://www.fdahelp.us/register-fda.html
what are the test requirements for examination glove for 510k submission ?
latex and nitrite examination gloves require both bio-compatibility and physical test reports as part of 510k notification. please visit below pages for test requirements
FDA biocompatibility tests required for gloves
FDA tests required for gloves
LMG can assist you with FDA 510k submission, we can also help you to register with FDA
Hi.. I am planning to import examination gloves from India to sell here in US. Do I need to have my own 510k number?
An importer does not have to submit a Premarket Notification 510(k) application to FDA on behalf of a manufacturer. Importers are also not required to list devices with FDA. They only have to register with FDA. But if an importer chooses to have ownership of a particular 510(k), they can submit a 510(k) application and change their establishment category using he list on the Who Must Register, List and Pay the Fee webpage.
We want to sell two eye doctor’s instruments, a slit lamp and an auto lens meter. I think i need premarket clearance for my products. Can you please check and confirm? Thanks in advance.
Sure we can help you with FDA registration. One of your product slit lamp is 510K exempted (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=4415) and auto lens meter also exempted from 510 Clearance (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=5676). For more details please check https://www.fdahelp.us/establishment-registration.html