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FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

SMG 1410.409 - DETERMINATIONS CONCERNING THE TYPE OF VALID SCIENTIFIC EVIDENCE SUBMITTED IN A PREMARKET APPROVAL APPLICATION.

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

The following officials are authorized to make determinations under section 513(a)(3)(D) of the act (21 U.S.C. 360c(a)(3)(D)) concerning the type of valid scientific evidence to be submitted in a premarket approval application that will provide a reasonable assurance that a device is effective under the conditions of use proposed by such person:

1. The Director and Deputy Director, CDRH.

2. The Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH.

3. The Director and Deputy Director, Office of In Vitro Diagnostic Devices Evaluation and Safety (OIVD), CDRH.

4. The Director, Program Operations Staff, ODE, CDRH.

5. For devices assigned to their respective Divisions: the Division Directors and Deputy Division Directors, ODE, CDRH.

2. REDELEGATION.

These officials may not further redelegate this authority.

3. EFFECTIVE DATE.

This delegation was approved on April 14, 2003.

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