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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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1-5 - CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

1-5 - CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
     1-5-1 - Office of Compliance
     1-5-2 - Division of Risk Management Operations
     1-5-3 - Division of Bioresearch Monitoring
     1-5-4 - Division of Enforcement A
     1-5-5 - Division of Enforcement B
     1-5-6 - Office of Communication, Education and Radiation Programs
     1-5-7 - Office of In Vitro Diagnostic Device Evaluation and Safety

 1-5 - CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

 1-5-1 - Office of Compliance

The Office of Compliance (OC) develops, directs, coordinates, evaluates, and monitors compliance programs covering regulated industry. OC conducts field tests and inspections when necessary for regulatory purposes, evaluates industry quality control and testing programs to ensure compliance with regulations, and provides advice to agency field offices on, and manages center activities relating to, legal actions, case development, and contested case assistance, and coordinates all field planning activities and issues all field assignments for the center.

There are four Divisions in the Office of Compliance:

  1. Division of Risk Management Operations;
  2. Division of Bioresearch Monitoring;
  3. Division of Enforcement A; and, 
  4. Division of Enforcement B.

 1-5-2 - Division of Risk Management Operations

The functional statements for the Division of Risk Management Operations are:

  1. Advises and supports office officials and staff regarding all policies and procedures relating to administrative support activities;
  2. Provides analysis activities for Office, Center and Agency senior management in the development and implementation of risk-base regulatory and enforcement activities;
  3. Advises Office officials and staff regarding management information system initiatives and serves as the Office liaison to other Center and Agency components on all such matters. Plans, coordinates, and implements an Office Information Technology strategic plan;
  4. Provides information for requests from external as well as internal sources. Coordinates and processes Freedom of Information requests (FOI) and issues certificates for requests to export approved medical devices and non-approved medical devices under 801(e) of the Federal Food, Drug, and Cosmetic Act (the Act);
  5. Coordinates the Center's administrative activities with field offices as well as internal regulatory actions;
  6. Develops, coordinates, and/or conducts medical device and electronic products training programs for field personnel and state and local agencies in coordination with other Center and Agency components; and,
  7. Develops, processes information for, and maintains the medical device registration and product listing system; develops and monitors contracts for data processing; ensures industry compliance with reporting requirements through a certification program; and develops and maintains a document tracking system.

There are three Branches within this Division:

  1. Field Operations Branch;
  2. Risk Management and Analysis Branch; and,
  3. Regulatory Policy and Systems Branch.

 1-5-3 - Division of Bioresearch Monitoring

The functional statements for the Division of Bioresearch Monitoring are:

  1. Enforces the Medical Device Amendments of 1976 and the Safe Medical Devices Acts of 1990 and 1992 and the Radiation Control for Health and Safety Act of 1972 as it relates to inspections;
  2. Manages and coordinates the administrative and regulatory responsibilities of the agency's Bioresearch Monitoring Program for medical devices; prepares related warning letters and other correspondence; ensures corrective actions taken by firms inspected under the Bioresearch Monitoring Compliance Program are acceptable;
  3. Assigns, directs, and coordinates on-site inspections of sponsors and investigators of preclinical and clinical device product studies, institutional review boards, commercial clinical testing facilities, and nonclinical toxicology laboratories in collaboration with the agency's field organization;
  4. Provides regulatory guidance and interpretations of the informed consent, institutional review board, and the investigational device exemption regulations to the field and industry;
  5. Designs, implements, and evaluates surveillance and compliance programs in the areas of preclinical and clinical investigational device product investigations. Manages the premarket approval data audit program to ensure the integrity of data submitted to the agency; and,
  6. Coordinates and implements the agency's Application Integrity Policy for medical devices.

There are three Branches within the Division of Bioresearch Monitoring:

  1. Program Enforcement Branches A and B; and,
  2. Special Investigations Branch.

 1-5-4 - Division of Enforcement A

Enforces medical device regulations as they relate to general surgical devices, dental; ear, nose, and throat (ENT); and ophthalmic devices; urology, gastroenterology; and obstetrics/gynecology (OB/GYN) devices; and general hospital devices.

There are four Branches within this Division:

  1. Dental, ENT, and Ophthalmic Devices Branch;
  2. General Hospital Devices Branch;
  3. General Surgical Devices Branch; and,
  4. OB/GYN, Gastroenterology, Urology Devices Branch.

 1-5-5 - Division of Enforcement B

Enforces medical device regulations as they relate to cardiovascular, radiologic, orthopedic, physical medicine, anesthesiology, and neurological devices.

There are four Branches within this Division:

  1. Cardiac Rhythm and Electrophysiology Devices Branch;
  2. Vascular and Circulatory Support Devices Branch;
  3. Orthopedic and Physical Medicine Devices Branch; and
  4. Radiology, Anesthesiology and Neurology Devices Branch

The functional statements for the Divisions of Enforcement A and B, as they relate to each division's specialty areas, are:

  1. Manages and coordinates activities associated with administrative and regulatory actions;
  2. Develops, interprets, and issues policy guidance in response to specific requests from the medical device, trade associations, other federal agencies, other countries, state agencies, and the general public; develops, reviews, and revises new and amended regulations including good manufacturing practices (GMP); 
  3. Plans, initiates, coordinates, and conducts medical device inspections and investigations of manufacturers and their products; and, 
  4. Identifies the need for and directs the development of compliance policy guides and programs to facilitate compliance by manufacturers; develops, coordinates, reviews, and revises medical device industry GMP regulations; develops and implements programs to ensure uniform interpretation and application of GMP and recommends regulatory action when appropriate.

 1-5-6 - Office of Communication, Education and Radiation Programs

  1. Division of Mammography Quality and Radiation Programs

    Enforces the Mammography Quality Standards Act and the electronic product radiation control provisions of the Federal Food, Drug, and Cosmetic Act as they relate to medical diagnostic and therapeutic and non-medical radiation-emitting electronic products.

    1. There are six Branches within this Division:
      1. Information Management Branch;
      2. Accreditation and Certification Branch;
      3. Radiation Programs Branch;
      4. Inspection and Compliance Branch;
      5. Electronic Products Branch; and,
      6. Diagnostic X-ray Devices Branch.
    2. The functional statements for the Division of Mammography Quality and Radiation Programs are:
      1. Manages and coordinates activities associated with administrative and regulatory actions regarding radiation-emitting electronic products and mammography facilities;
      2. Develops, interprets, and issues policy guidance in response to specific requests from the medical device and electronic product industries, mammography facilities, professional and trade associations, other federal agencies, other countries, state agencies, and the general public;
      3. Develops, reviews, and revises new and amended regulations including good manufacturing practice (GMP) and performance standards for radiation-emitting electronic products and quality standards for mammography facilities;
      4. Plans, initiates, coordinates, and conducts inspections and investigations of manufacturers and certain specific users of radiation-emitting diagnostic, and therapeutic medical devices and non-medical electronic products; also includes inspections and investigations of mammography facilities;
      5. Reviews and evaluates design, test, and production data and reports from manufacturers of radiation-emitting medical and non-medical diagnostic and therapeutic devices to ensure compliance with promulgated standards and regulations;
      6. Identifies the need for and directs the development of compliance policy guidance and programs to facilitate compliance by manufacturers of radiation-emitting medical and non-medical diagnostic and therapeutic devices, as well as mammography facilities;
      7. Develops, coordinates, reviews, and revises medical device industry GMP regulations as they pertain to radiation-emitting diagnostic and therapeutic devices; and,
      8. Develops and implements programs to ensure uniform interpretation and application of GMP and recommends regulatory action when appropriate.

 1-5-7 - Office of In Vitro Diagnostic Device Evaluation and Safety

The Office of In Vitro Diagnostic Device Evaluation and Safety enforces medical device regulations as they relate to in vitro diagnostic devices. The functional statements for this office relating to compliance and enforcement activities involving in vitro diagnostic devices are:

  1. Manages and coordinates activities associated with administrative and regulatory actions;
  2. Develops, interprets, and issues policy guidance in response to specific requests from the in vitro diagnostic device industry, trade associations, other federal agencies, other countries, state agencies, and the general public; develops, reviews, and revises new and amended regulations and standards for in vitro diagnostic devices;
  3. Plans, initiates, coordinates, and conducts inspections and investigations of in vitro diagnostic device manufacturers and their products; reviews and evaluates design, test, and production data and reports from manufacturers to ensure compliance with regulations; and,
  4. Identifies the need for and directs the development of compliance policy guides and programs to facilitate compliance by manufacturers. Develops and implements programs to ensure uniform interpretation and application of GMP and recommends regulatory action when appropriate.