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1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.
A. The following officials are authorized under section 523(a)(1) and (b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360m(a)(1) and (b)(2)(A)) to respond to a request for accreditation and to accredit persons for the purpose of reviewing reports submitted under section 510(k) of the act (21 U.S.C. 360(k)) and making recommendations regarding the initial classification of devices:
1. The Director and Deputy Director, Center for Devices and Radiological Health (CDRH).
2. The Director and Deputy Director, Office of Health and Industry Programs (OHIP), CDRH.
3. The Director and Deputy Director, Division of Small Manufacturers Assistance (DSMA), OHIP, CDRH.
B. The following officials are authorized under section 523(a)(2)(B) and (C) of the act (21 U.S.C. 360m(a)(2)(B) and (C)) to make a determination with respect to the recommendation of an initial classification of a device; and to change the initial classification under section 513(f)(1) of the act (21 U.S.C. 360c(f)(1)) that is recommended by an accredited person to provide to such person, and the person who submitted the report under section 510(k) of the act (21 U.S.C. 360(k)) for the device, a statement explaining in detail the reasons for the change:
1. The Director and Deputy Director, CDRH.
2. The Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH.
3. The Division Directors and Deputy Division Directors, ODE, CDRH.
4. The Director and Deputy Director, Office of In Vitro Diagnostic Devices Evaluation and Safety, (OIVD), CDRH.
5. The Division Directors and Deputy Division Directors, OIVD, CDRH.
C. The following officials are authorized under section 523(b)(2)(B) of the act (21 U.S.C. 360m(b)(2)(B)) to suspend or withdraw accreditation of any person accredited to review reports and to make recommendations under section 523 of the act (21 U.S.C. 360m):
1. The Director and Deputy Director, CDRH.
2. The Director and Deputy Director, OHIP, CDRH.
3. The Director and Deputy Director, DSMA, OHIP, CDRH.
D. The following officials are authorized under section 523(b)(2)(C) of the act (21 U.S.C. 360m(b)(2)(c)) to implement the measures described in that section to ensure that persons accredited under section 523 of the act (21 U.S.C. 360m) will continue to meet the standards of accreditation:
1. The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.
2. The Director and Deputy Director, Office of Compliance, CDRH.
2. REDELEGATION.
These officials may not further redelegate these authorities.
3. EFFECTIVE DATE.
This delegation was approved on April 14, 2003.