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  5. Inspection and Field Testing of Radiation-Emitting Electronic Products - Part: VI - References, Attachments, and Program Contacts
  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

Inspection and Field Testing of Radiation-Emitting Electronic Products - 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

      21 CFR 1010, Performance Standards for Electronic Products: General

      21 CFR 1020 – 1050, Specific Performance Standards for Electronic Products

    3. Regulatory Procedures Manual (RPM)

    4. Investigations Operations Manual (IOM) - Chapter 5

    5. FDA Web Sites

      FDA home page

      ORA home page

      CDRH home page

      Field Accomplishments and Compliance Tracking System (FACTS) — FDA Intranet Only

      Electronic Product Radiation Control home page

      Product Code Classification Database (searchable)

      Good Guidance Practices Database (searchable)

  2. Attachments

    1. Attachment A – Classification table for reporting and quality control testing program Non-Compliant Items (common to all EPRC inspections and field tests)
    2. Attachment B – Specific Instructions for Laser Product Inspections and Tests
    3. Attachment C – Specific Instructions for Sunlamp Product Inspections and Tests
    4. Attachment D – Specific Instructions for Cabinet X-Ray Product Inspections and Tests
    5. Attachment E – Specific Instructions for Television Product Inspections and Tests
    6. Attachment F – Specific Instructions for Microwave Oven Product Inspections and Tests

  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, Electronic Products Branch, FDA/CDRH Office of Communication, Education and Radiation Programs (HFZ-240), 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002.

    Name Phone Email Position / Expertise
    Robert Doyle 301-796-5863 [email protected] Chief, Electronic Products Branch
    Dr. Helen Barr 301-796-5713 [email protected] Director, DMQRP
    Sean Boyd 301-796-5895 [email protected] Deputy Director, DMQRP
    Nancy Bennaugh 301-796-6642 [email protected] Program Analyst
    Daniel Hewett 301-796-5864 [email protected] Consumer Safety Officer, laser products
    Dan Kassiday 301-796-5865 [email protected] Engineer, cabinet, industrial, analytical, security x-ray products
    George Kraus 301-796-5866 [email protected] Consumer Safety Officer, TV and microwave oven products, imports
    L. Dale Smith 301-796-5868 [email protected] Consumer Safety Officer, laser light show products
    Cory Tylka 301-796-5869 [email protected] Consumer Safety Officer, medical laser products
    Varsha Savalia 301-796-5867 [email protected] Consumer Safety Officer, sunlamp and UV and laser products
    Sharon Miller 301-796-2471 [email protected] Engineer, UV products and regulations

    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
    Ilko Ilev 301-796-2489 [email protected] Laser technology expert
    Mary Walker 301-796-2558 [email protected] X-ray instrumentation and calibration

    Office of Regulatory Affairs

    Field Regional Radiological Health Representatives

    Name Phone Email Mail Stop Position
    Karen Smallwood 615-366-7823 [email protected] HFR-SE350 Consumer Safety Officer
    Rachel Evans 312-596-6518 [email protected] HFR-CE25 Consumer Safety Officer
    Scotty Hargrave 214-253-4930 [email protected] HFR-SW19 SW RRHR
    Terri Jones 503-671-9711 x36 [email protected] HFR-PA3515 Consumer Safety Officer

    Field Electro-Optics Specialists and laser product contacts

    Name Phone Email Mail Stop Position
    Emir Galevi 781-729-5700 x724 [email protected] HFR-NE480 Engineer, WEAC
    Leo Lagrotte 813-228-2671 x35 [email protected] HFR-SE2585 Electro-Optics Specialist, SER
    James E. Frye 513-684-2700 x149 [email protected] HFR-CE400 Electro-Optics Specialist, CER
    Don Leeseberg 210-541-9450 [email protected] RP-MOB 1075 Consumer Safety Officer, SWR

    Winchester Engineering and Analytical Center contacts

    Name Phone Email Mail Stop Position
    Brian Baker 781-756-9701 [email protected] HFR-NE400 WEAC Director
    Jim Cherniack 781-756-9711 [email protected] HFR-NE400 Radiation Safety Officer
    Joe Matrisciano 781-756-9705 [email protected] HFR-NE480 Engineering Supervisor

    Headquarters contacts

    Name Phone Email Mail Stop Position
    Mei-Ying Li 301-796-5903 [email protected] ELEM-3019 ORO, DFSR

 

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