When 510(k) submission is needed

Unless exempted, the 510(k) submission for a medical device is needed in the following scenarios:

# When a new device has to enter into the commercial distribution (Marketing) for the first time.

# When a legally marketed device has a change/modification which affects the safety and effectiveness of the device significantly. (Even if the device is marketed before May 28, 1976).

# When a legally marketed device has a change/ modification, for a new or different intended use.

When 510(k) submission is not required

In the following scenarios 510(k) submission is not required for the medical devices to be marketed in the US.

· When you sell unfinished devices to another firm for further processing

· When you sell components used to assemble devices to another firm

· When your device is not marketed.

· When you distribute another firm’s domestically manufactured devices.

· In case of re-packager or re-labeler, one could market the device without submitting 510(k) if the existing label (as submitted to 510(k)) and condition of the device are not significantly changed. The label should carry the same indications for use, warnings, and contraindications.

· Devices commercially distributed before May 28, 1976. (Pre-amendment Status). And the device doesn’t have any significant change or modification in design, components, manufacturing process, or manufacturing method and intended use.

· Importer of the foreign-made medical device. (Foreign manufacturer has to proceed for 510(k) submission for market clearance of his medical device).

· Exempted device by regulation 21 CFR (862–892).

Those looking for medical device 510k consultants for early submission and clearance may contact us by email: enquiry@i3cglobal.com