U.S. 510(k)s

• Do you have a “me-too” medical device that is FDA Class II?
• Are you ready to submit your supporting documentation?
• Unsure of which type of 510(k) application to submit?
• Thinking about submitting a STED submission instead of a standard 510(k)?

Companies located worldwide can benefit from Donawa Lifescience Consulting assistance and support in understanding and responding to U.S. product submission requirements.

Donawa Lifescience Consulting can help your company to obtain FDA marketing clearance for Class II products by:

Assisting you in understanding U.S. submission requirements; Developing 'Traditional', 'Abbreviated' or 'Special' 510(k) submission documentation which meets FDA expectations; Identifying and obtaining applicable guidance documents and consensus standards; and Assisting in the development of labeling, including user manuals, that meets U.S. regulatory and customer requirements.