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FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY

MEDICAL DEVICES AND RADIOLOGICAL HEALTH: INDEX PAGE

(Updated 06/12/2008)

Guide 1410.400

1410.401 Issuance of Federal Register Documents to Recognize or to Withdraw Recognition of a Standard to Meet Premarket Submission Requirements

1410.402 Issuance of Federal Register Documents Pertaining to Premarket Submssion Requirements and Exemption from Premarket Notification

1410.403 Detention of Adulterated or Misbranded Medical Devices

1410.404 Authorization to Use Alternative Evidence for Determination Of the Effectiveness of Medical Devices

1410.405 Notification to Petitioners of Determinations Made on Petitions For Reclassification of Medical Devices

1410.406 Determination of Classification of Devices

1410.407 Notification to Sponsors of Deficiencies in Petitions for Reclassification of Medical Devices

1410.408 Approval, Disapproval, or Withdrawal of Approval of Product Development Protocols and Applications for Premarket Approval, and Humanitarian Device Exemptions for Medical Devices

1410.409 Determinations Concerning the Type of Valid Scientific Evidence Submitted in a Premarket Approval Application

1410.410 Determination that Medical Present Unreasonable Risk of Substantial Harm

1410.411 Orders to Repair or Replace, or Make Refunds for, Medical Devices

1410.412 Medical Device Recall Authority

1410.413 Temporary Suspension of a Medical Device Application

1410.414 Approval, Disapproval, or Withdrawal of Approval of Applications and Entering Into Agreements for Investigational Device Exemptions

1410.415 Postmarket Surveillance

1410.416 Authority Relating to Medical Device Reporting Procedures

1410.417 Medical Device Tracking

1410.418 Authority Pertaining to Accreditation Functions for Medical Devices

1410.419 Medical Device User Fee Authorities

1410.420 Requests for Information Concerning Device Classification (if any) and Requirements

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