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U.S. Department of Health and Human Services

Medical Devices

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Inspection of Domestic and Foreign Manufacturers of Diagnostic X-Ray Equipment - Part VI: References, Attachments and Program Contacts

PART VI - REFERENCES, ATTACHMENTS AND PROGRAM CONTACTS

  1. References

    1. Law

      Federal Food, Drug, and Cosmetic Act, As Amended
      Electronic Product Radiation Control Provisions (formerly known as the Radiation Control for Health and Safety Act of 1968, Public Law 90-602, 0ctober 18, 1968)

    2. Regulations

      21 CFR 1000 – 1005, General Requirements for All Electronic Products which Emit Radiation
      http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPartFrom=1000&CFRPartTo=1005

      21 CFR 1010, Performance Standards for Electronic Products: General
      http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1010

      21 CFR 1020 – 1050, Specific Performance Standards for Electronic Products
      http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPartFrom=1020&CFRPartTo=1050

    3. Regulatory Procedures Manual (RPM)

    4. Investigations Operations Manual (IOM) - Chapter 5

    5. Compliance Program 7382.845 - Inspection of Medical Device Manufacturers

    6. FDA Web Sites

      FDA home page

      ORA home page

      CDRH home page

      Field Accomplishments and Compliance Tracking System (FACTS)
      (visit ORA’s home page, then click the FACTS icon.)

      Electronic Product Radiation Control home page

      Product Code Classification Database (searchable)
      http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/pcdsimplesearch.cfm

      CDRH Good Guidance Practices Page (searchable)

  2. Attachments

    1. Attachment A – Diagnostic X-Ray Product Codes
  3. Program Contacts

    Center for Devices and Radiological Health

    Office of Communication, Education and Radiation Programs, Division of Mammography Quality and Radiation Programs (DMQRP)

    Contact for support in planning and executing inspections and field tests, classification of items of non-compliance, and for interpretation and current policy on EPRC requirements. Send all inspection and test reports to Chief, Diagnostic Devices Branch, FDA/CDRH Office of Communication, Education and Radiation Programs 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

    Name Phone Email Position/Expertise
    Sean Boyd (301) 796-5895 sean.boyd@fda.hhs.gov Deputy Director, DMQRP
    Dr. Helen Barr (301) 796-5713 helen.barr@fda.hhs.gov Director, DMQRP
    Dr. Donald Miller (301) 796-5712 donald.miller@fda.hhs.gov Acting Chief, Diagnostic Devices Branch
    Charles Gunzburg (301) 796-5898 charles.gunzburg@fda.hhs.gov Consumer Safety Officer, diagnostic x-ray products
    Tommy Mosely (301) 796-5908 tommy.mosely@fda.hhs.gov Consumer Safety Officer, diagnostic x-ray products
    Ellyce Ratskoff (301) 796-5909 ellyce.ratskoff@fda.hhs.gov Consumer Safety Officer, EPRC workplanning
    Nick Walker (301) 796-5910 james.walker@fda.hhs.gov Consumer Safety Officer, diagnostic x-ray products
    William Maloney (301) 796-6272 william.maloney@fda.hhs.gov Physicist, Diagnostic Devices Branch
    Charles Myers (301) 796-5619 charles.myers@fda.hhs.gov Consumer Safety Officer, diagnostic xray products
    Office of Science and Engineering Laboratories

    Contact for assistance with identifying appropriate instrumentation for use in measuring electronic product radiation emissions.

    Name Phone Email Position
    Mary Walker (301) 796-2558 mary.walker@fda.hhs.gov X-ray instrumentation and calibration
    Office of Regulatory Affairs

    Field Regional Radiological Health Representatives

    Name Phone Email Mail Stop Position
    Elizabeth O'Malley (718) 662-5621 elizabeth.omalley@fda.hhs.gov HFR-NE4 NE RRHR
    Karen Smallwood (615) 366-7823 karen.smallwood@fda.hhs.gov HFR-SE350 SE RRHR
    Rachel Evans (312) 596-6518 rachel.evans@fda.hhs.gov HFR-CE25 CE RRHR
    Scotty Hargrave (214) 253-4930 scotty.hargrave@fda.hhs.gov HFR-SW19 SW RRHR
    Terri Jones (503) 671-9711 x36 terri.jones@fda.hhs.gov HFR-PA3515 PA RRHR
    Winchester Engineering and Analytical Center contacts
    Name Phone Email Mail Stop Position
    Brian Baker (781) 756-9701 brian.baker@fda.hhs.gov HFR-NE400 WEAC Director
    Jim Cherniak (781) 729-5700 james.cherniack@fda.hhs.gov HFR-NE400 Radiation Safety Officer
    Vacant Vacant Vacant HFR-NE400 Engineering Branch Director, WEAC
    Jane Driscoll (781) 729-5700 x716 jane.driscoll@fda.hhs.gov HFR-NE480 Metrology Supervisor
    Joe Matrisciano (781) 729-5700 x736 joseph.matrisciano@fda.hhs.gov HFR-NE480 Engineering Supervisor
    Headquarters contacts
    Name Phone Email Mail Stop Position
    Mei-Ying Li (301) 827-2913 meiying.li@fda.hhs.gov HFC-150 ORO, DFSR