SMG 1258.94

FDA Staff Manual Guides, Volume I – Organizations and Functions

Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Office of Product Evaluation and Quality

Office of In Vitro Diagnostics and Radiological Health

Division of Radiological Health

Effective Date: December 14, 2018

1. Division of Radiological Health (DCCFID).

A. Serves as the primary source for scientific and medical expertise on medical devices with regard to safety and effectiveness.

B. Carries out scientific and end-to-end medical device review evaluation.

C. Coordinates actions on classification of medical devices.

D. Coordinates, carries out, and makes premarket review determinations.

E. Plans and coordinates post market compliance and enforcement efforts related to medical devices. Participates in development and interpretation of post market regulations and policies related to medical devices.

F. Reviews and evaluates design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.

G. Develops, oversees and implements requirements and policies related to reports of problems and hazards, product reports, supplemental reports, abbreviated reports, and annual reports, exemptions from reporting, requests for variances, and recordkeeping.

SMG 1258.94 (12/14/2018) 1 2. Magnetic Resonance and Electronic Products Branch (DCCFID1).

A. Serves as the primary source for regulatory, scientific and medical expertise on magnetic resonance devices and electronic products.

B. Coordinates, carries out, and makes preliminary premarket review determinations.

C. Plans, manages, enforces, develops and interprets postmarket laws, regulations and policies related to magnetic resonance devices and electronic products.

3. Diagnostic X-Ray Systems Branch (DCCFID2).

A. Serves as the primary source for regulatory, scientific and medical expertise on diagnostic x-ray systems.

B. Coordinates, carries out, and makes preliminary premarket review determinations.

C. Plans, manages, enforces, develops and interprets postmarket laws, regulations and policies related to diagnostic x-ray systems.

4. Nuclear Medicine and Radiation Therapy Branch (DCCFID3).

A. Serves as the primary source for regulatory, scientific and medical expertise on nuclear medicine and radiation therapy devices.

B. Coordinates, carries out, and makes preliminary premarket review determinations.

C. Plans, manages, enforces, develops and interprets postmarket laws, regulations and policies related to on nuclear medicine and radiation therapy devices.

5. Mammography, Ultrasound and Imaging Software Branch (DCCFID4).

A. Serves as the primary source for regulatory, scientific and medical expertise on mammography, ultrasound and medical imaging devices.

B. Coordinates, carries out, and makes preliminary premarket review determinations.

C. Plans, manages, enforces, develops and interprets postmarket laws, regulations and policies related to mammography, ultrasound and medical imaging devices.

SMG 1258.94 (12/14/2018) 2 6. Authority and Effective Date.

The functional statements for the Division of Radiological Health were approved by the Secretary of Health and Human Services and effective on December 14, 2018.

SMG 1258.94 (12/14/2018) 3

Staff Manual Guide 1258.94 Organizations and Functions Effective Date: December 14, 2018

The following is the Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of In Vitro Diagnostics and Radiological Health, Division of Radiological Health organization structure depicting all the organizational structures reporting to the Director.

These branches report to the Division of Radiological Health (DCCFID) • Magnetic Resonance & Electronic Products Branch (DCCFID1) • Diagnostic X-Ray Systems Branch (DCCFID2) • Nuclear Medicine & Radiation Therapy Branch (DCCFID3) • Mammography, Ultrasound & Imaging Software Branch (DCCFID4)

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