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Fda Approved Vs Fda Clear

When FDA review is needed prior to marketing a medical device, FDA will either:

"Clear" the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA

OR

"Approve" the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.

Whether a 510(k) or a PMA application needs to be filed depends on the classification of the medical device.

To acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is "substantially equivalent" to a device that is already legally marketed for the same use.

To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device's safety and effectiveness.

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Our Locations

Four Convenient Locations!

Office Hours

Our Regular Schedule

Frederick Location

Monday:

8:30 am-4:30 pm

Tuesday:

8:30 am-4:30 pm

Wednesday:

8:00 am-4:30 pm

Thursday:

8:30 am-4:30 pm

Friday:

8:30 am-4:30 pm

Saturday:

Closed

Sunday:

Closed

Gettysburg Location

Monday:

8:30 am-4:30 pm

Tuesday:

8:30 am-4:30 pm

Wednesday:

8:30 am-4:30 pm

Thursday:

8:30 am-4:30 pm

Friday:

8:30 am-4:30 pm

Saturday:

Closed

Sunday:

Closed

Brunswick Location

Monday:

Closed

Tuesday:

9:00 am-11:45 am

Wednesday:

Closed

Thursday:

Closed

Friday:

Closed

Saturday:

Closed

Sunday:

Closed

Hagerstown Hours

Monday:

8:15 am-4:30 pm

Tuesday:

8:15 am-4:30 pm

Wednesday:

8:15 am-4:30 pm

Thursday:

8:15 am-4:30 pm

Friday:

8:15 am-4:30 pm

Saturday:

Closed

Sunday:

Closed