and Office of Therapeutics Research and Review (OTRR), CBER. (b)(1) The following officials, for medical devices assigned to their respective organizations, are authorized to approve, disapprove, or withdraw approval of applications for premarket approval for medical devices submitted under sections 515 and 520(1) of the act (21 U.S.C. 360e and 360j(1)): (i) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, the Director and Deputy Directors, ODE, CDRH, and the Division Directors, ODE, CDRH. (ii) The Director and Deputy Directors, CBER, and the Directors and Deputy Directors, OBRR, OVRR, and OTRR, CBER. (2) For medical devices assigned to their respective division, the Division Directors, Office of Device Evaluation, CDRH, are authorized to approve, disapprove, or withdraw approval of supplemental premarket applications. (c) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, for medical devices assigned to their organization, are authorized to issue notices to announce the approval, disapproval, or withdrawal of approval of a device, and to make publicly available detailed summary of the information on which the decision was based, under sections 515(d), (e), and (g) and 520(h)(1) of the act (21 U.S.C. (d), (e), and (g) and 360j(h)(1)). a (d) These officials may not further redelegate these authorities. § 5.408 Determinations concerning the type of valid scientific evidence submitted in a premarket approval application. (a) 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: (i) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (ii) The Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH. (iii) The Director, Program Operations Staff, ODE, CDRH. (iv) For devices assigned to their respective Divisions: the Division Directors and Deputy Division Directors, ODE, CDRH. (b) These officials may may not further redelegate this authority. $5.409 Determinations that medical devices present unreasonable risk of substantial harm. (a) The following officials, for medical devices assigned to their respective organizations, are authorized to determine that medical devices present an unreasonable risk of substantial harm to the public health, and to order adequate notification thereof, under section 518(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(a)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Director, Office of Compliance, CDRH. (2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Director, Office of Compliance and Biologics Quality, CBER. (3) The Director, the Deputy Director, and the Directors, Office of Review Management and Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); and the Director and Deputy Director, Office of Compliance, CDER. (b) These officials may not further redelegate this authority. § 5.410 Orders to repair or replace, or make refunds for, medical devices. (a) The following officials, for medical devices assigned to their respective organizations, are authorized to order repair or replacement of, or refund for, medical devices under section 518(b) and (c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(b) and (c)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Director, Office of Compliance, CDRH. (2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER. (3) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); and the Director and Deputy Director, Office of Compliance, CDER. (b) These officials may not further redelegate this authority. § 5.411 Medical device recall authority. (a) The following officials, for medical devices assigned to their respective organizations, are authorized to perform all of the recall functions under section 518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e)), which have been delegated to the Commissioner of Food and Drugs: (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH). (2) The Director and Deputy Director, Office of Compliance, CDRH. (3) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); and the Director and Deputy Director, Office of Compliance, CDER. (4) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER. (b) These officials may not further redelegate this authority. $5.412 Temporary suspension of a medical device application. (a) The following officials for medical devices assigned to their respective organizations are authorized under section 515(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(e)), to determine that there is reasonable probability that continuation of the distribution of a device under an approved application would cause serious adverse health consequences or death, and upon making such a determination, to issue an order to temporarily suspend the approval of an application: (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH). (2) The Director and Deputy Director, Office of Compliance, CDRH. (3) The Director and Deputy Directors, Office of Device Evaluation, CDRH. (4) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); the Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER; the Director and Deputy Director, Office of Generic Drugs, Office of Pharmaceutical Science, CDER; and the Director and Deputy Director, Office of Compliance, CDER. (5) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER. (b) These officials may not further redelegate this authority. $5.413 Approval, disapproval, or withdrawal of approval of applications and entering into agreements for investigational device exemptions. (a) For medical devices assigned to their respective organizations, the following officials are authorized to approve, disapprove, or withdraw approval of applications for investigational device exemptions submitted under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), the Director and Deputy Directors, Office of Device Evaluation, CDRH, and the Director and Deputy Director, Office of Compliance, CDRH. (2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Therapeutics Research and Review (OTRR), CBER. (b) For medical devices assigned to their respective divisions, the Division Directors, Office of Device Evaluation, CDRH, are authorized to approve, disapprove, or withdraw approval of applications for investigational device exemptions submitted under section 520(g) of the act (21 U.S.C. 360j(y)). (c) The following officials are authorized to enter into written agreements concerning investigational device exemption protocols under section 520(g)(7) of the act (21 U.S.C. 360j(g)(7)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH. (3) The Director, Program Operations Staff, ODE, CDRH. (4) The Chief, Investigational Device Exemption Section, ODE, CDRH. (5) For medical devices assigned to their respective Divisions: The Division Directors and Deputy Division Directors, ODE, CDRH. (6) The Director and Deputy Directors, CBER, and the Director and Deputy Directors of the OBRR, OVRR, and OTRR, CBER. (d) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH and the Director and Deputy Directors, ODE, CDRH, the Director and Deputy Directors, CBER, and the Director and Deputy Directors of the OBRR, OVRR, and OTRR, CBER, are authorized to make decisions under section 520(g)(7) of the act (21 U.S.C. 360j(g)(7)) with respect to an agreement on an investigational plan, that a substantial scientific issue essential to determining the safety and effectiveness of the device involved has been identified. (e) These officials may not further redelegate these authorities. $5.414 Postmarket surveillance. (a) For any class II or class III device (including any device that is or contains a drug or biologic), the failure of which would be reasonably likely to have serious adverse health consequences, or which is intended to be implanted in the human body for more than 1 year, or a life supporting or life sustaining device used outside a user facility, any of the following officials is authorized to require a manufacturer of such device to conduct postmarket surveillance: (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH). (2) The Director and Deputy Director, Office of Surveillance and Biometrics, CDRH. (3) The Director and Deputy Director, Division of Postmarket Surveillance, Office of Surveillance and Biometrics (OSB), and the Director, Issues Management Staff, OSB, CDRH. (4) The Director and Deputy Directors, Office of Device Evaluation, CDRH. (5) The Director and Deputy Director, Office of Science and Technology, CDRH. (6) The Director and Deputy Director, Office of Health and Industry Programs, CDRH. (7) The Director and Deputy Director, Office of Compliance, CDRH. (8) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER). (9) The Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER. (10) The Director and Deputy Director, Office of Compliance, CDER. (11) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER). (12) The Director and Deputy Director, Office of Compliance and Biologics Quality, CBER. (13) The Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, and Office of Therapeutics Research and Review, CBER. (b) These officials may not further redelegate these authorities. $5.415 Authority relating to medical device reporting procedures. (a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), the Director and Deputy Director, Office of Surveillance and Biometrics (OSB), CDRH, and the Director and Deputy Director, Division of Surveillance Systems (DSS), OSB, CDRH, are authorized to approve electronic reporting under § 803.14 of this chapter. (b) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, the Director and Deputy Director, OSB, CDRH, and the Director and Deputy Director, DSS, OSB, CDRH are authorized to request the submission of additional information under § 803.15 of this chapter. (c) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, the Director and Deputy Director, OSB, CDRH, and the Director and Deputy Director, DSS, OSB, CDRH are authorized to grant or revoke exemptions and variances from reporting requirements under § 803.19 of this chapter. (d) These officials may not further redelegate these authorities. $5.416 Medical device tracking. (a) The following officials are authorized to issue orders under section 519(e) of the Federal Food Drug and Cosmetic Act (21 U.S.C. 360i(e)) requiring manufacturers to adopt methods of tracking devices: (1) The Director and Deputy Directors, Center for Devices and Radiological Health (CDRH). (2) The Director and Deputy Director, Office of Compliance, CDRH. (b) These officials may not further redelegate this authority. $5.417 Authority pertaining to accreditation functions for medical devices. (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 Directors for Science and for Regulations and Policy, 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 Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH. (3) The Division Directors and Deputy Division Directors, ODE, 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 Directors for Science and for Regulations and Policy, 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. (e) These officials may not further redelegate these authorities. Subpart G-Animal Drugs; $5.500 Issuance of Federal Register documents pertaining to the determination of safe levels, notice of need for development of an analytical method, notice of availability of a developed analytical method, and prohibition of certain extralabel drug use. The Director and Deputy Director, Center for Veterinary Medicine (CVM) are authorized to issue FEDERAL REGISTER documents pertaining to the determination of safe levels, notice of need for development of an analytical method, notice of availability of a developed analytical method, and prohibition of certain extralabel drug use related to implementation of section 512(a)(4) and (5) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360b(a)(4) and (5)). These officials may further redelegate this authority. § 5.501 Approval of new animal drug applications, medicated feed mill license applications and their supplements. (a) The Director and Deputy Director, Center for Veterinary Medicine (CVM), are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) with regard to the approval of new animal drug applications, and supplements thereto, for new animal drugs submitted under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b). (b) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs with regard to the approval of supplemental applications to approved new animal drugs submitted under section 512 of the act (21 U.S.C. 360b): (1) The Director, the Deputy Director for Human Food Safety and Consultative Services, and the Deputy Director for Therapeutic and Production Drug Review, Office of New Animal Drug Evaluation, CVM. (2) The Director and Deputy Director, Office of Surveillance and Compliance, CVM. (c) The following officials are authorized to perform all the functions of the Commissioner with regard to the approval of supplemental applications to new animal drug applications that are described by section 514.8(a)(4)(iii), (iv), and (v), and (d)(3) of this chapter. (1) The Director, Division of Manufacturing Technologies, Office of New Animal Drug Evaluation, CVM. (2) The Director, Division of Epidemiology and Surveillance, Office of Surveillance and Compliance, CVM. (d) The following officials are authorized to perform all the functions of the Commissioner with regard to the approval of medicated feed mill license applications for the manufacture of animal feeds containing new animal drugs under section 512(m) of the act (21 U.S.C. 360b(m), as amended by the Animal Drug Availability Act of 1996 (Public Law 104-250): (1) The Director and Deputy Director, CVM. (2) The Director, Division of Animal Feeds, Office of Surveillance and Compliance, CVM. (3) The Leader, Medicated Feeds Team, Division of Animal Feeds, Office of Surveillance and Compliance, CVM. (4) The Medicated Feeds Specialist, Medicated Feeds Team, Division of Animal Feeds, Office of Surveillance and Compliance, CVM. (e) These officials may not further redelegate these authorities. § 5.502 Issuance of notices, proposals, and orders relating to new animal drugs and medicated feed mill license applications. (a) The Director and Deputy Director, Center for Veterinary Medicine (CVM), are authorized to: (1) Issue notices of opportunity for a hearing on proposals to refuse approval or to withdraw approval of new animal drug applications, and supplements thereto, for drugs for animal use and proposals to refuse approval or to revoke approval of medicated feed mill license applications, and supplements thereto, submitted under section 512(m) of the Federal Food, Drug, and |