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Frederick Podiatrist | Frederick FDA Approved vs. FDA Clear | MD | Atlantic Foot & Ankle Specialists |

Atlantic Foot & Ankle Specialists
Frederick: (301) 694-8880

Gettysburg: (717) 334-1825
Brunswick: (301) 834-9339
Westminster: (301) 694-8880

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.

 

 
 
 
Frederick Podiatrist Atlantic Foot & Ankle Specialists is a poidiatry office providing FDA Approved vs. FDA Clear, orthopedic, pain, diabetes, bunions and much more in Frederick, MD. We also do Achilles Tendonitis, Athlete's Foot, Bunions, Calluses, Diabetic Foot Care, Flat Feet, Hammertoes, Heel Pain / Plantar Fasciitis, Infections, Ingrown Toenails, Neuroma, Nail Fungus, Arthritis, Pediatric Foot Care, Plantar Warts, Plantar Fasciitis, Running Injuries, Sprains/Strains, Tarsal Tunnel Syndrome, Toe Deformities and all work related in the 21701 area and surrounding areas in Frederick