Case Study: Ophthalmic Surgical Device 510(k)

A small manufacturer of Class I ophthalmic surgical devices wanted to start manufacturing a Class II permanent implant but did not have the expertise, experience or regulatory staff needed to prepare a 510(k) submission.

An AlvaMed consultant worked with the client’s engineering and quality resources to identify what testing would be needed, which predicate devices would be used to make the determination of substantial equivalence, coordinated biocompatibility testing and drafted the submission.  An audit of the Design History File for the product was also conducted prior to making the submission.

The FDA did not request any additional information during their review of the 510(k) and the client received notification of approval 85 days after submitting the 510(k).
 

 Bob DiNitto
 Vice-President
 Quality Assurance,
 Regulatory Affairs,
 & Design Control