HHS 223200810017I Economic Analysis of CDRHSubmission Requirements ... by the FDACenter for Devices and Radiological Health (CDRH), particularly the Premarket Approval (PMA) and the 510(k) processes.
for Industry and CDRH Staff ...World Wide Web/CDRH home page at http.//www.fda.gov/cdrh or CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number 159 when prompted for the document shelf number ... for Industry and CDRH Staff.
