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horizonal rule

See Related InformationPMA/510(k) Expedited Review - Guidance for Industry and CDRH Staff

This document is intended to provide guidance. It represents the Agency's current thinking on the above. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

Office of Device Evaluation, Program Operations Staff

Document Issued on: March 20, 1998

This document has been replaced on 11/21/03 by the document located at:

http://www.fda.gov/cdrh/mdufma/guidance/108.html

 

Updated 3/20/1998

horizonal rule

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