Medical Devices

Inspection and Field Testing of Radiation-Emitting Electronic Products - 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.

    NamePhoneEmailPosition / Expertise
    Robert Doyle301-796-5863robertj.doyle@fda.hhs.govChief, Electronic Products Branch
    Dr. Helen Barr301-796-5713helen.barr@fda.hhs.govDirector, DMQRP
    Sean Boyd301-796-5895sean.boyd@fda.hhs.govDeputy Director, DMQRP
    Nancy Bennaugh301-796-6642Nancy.bennaugh@fda.hhs.govProgram Analyst
    Daniel Hewett301-796-5864daniel.hewett@fda.hhs.govConsumer Safety Officer, laser products
    Dan Kassiday301-796-5865daniel.kassiday@fda.hhs.govEngineer, cabinet, industrial, analytical, security x-ray products
    George Kraus301-796-5866george.kraus@fda.hhs.govConsumer Safety Officer, TV and microwave oven products, imports
    L. Dale Smith301-796-5868l.smith@fda.hhs.govConsumer Safety Officer, laser light show products
    Cory Tylka301-796-5869corinne.tylka@fda.hhs.govConsumer Safety Officer, medical laser products
    Varsha Savalia301-796-5867varsha.savalia@fda.hhs.govConsumer Safety Officer, sunlamp and UV and laser products
    Sharon Miller301-796-2471sharona.miller@fda.hhs.govEngineer, 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.

    Ilko Ilev301-796-2489Ilko.ilev@fda.hhs.govLaser technology expert
    Mary Walker301-796-2558mary.walker@fda.hhs.govX-ray instrumentation and calibration

    Office of Regulatory Affairs

    Field Regional Radiological Health Representatives

    NamePhoneEmailMail StopPosition
    Karen Smallwood615-366-7823karen.smallwood@fda.hhs.govHFR-SE350Consumer Safety Officer
    Rachel Evans312-596-6518rachel.evans@fda.hhs.govHFR-CE25Consumer Safety Officer
    Scotty Hargrave214-253-4930scotty.hargrave@fda.hhs.govHFR-SW19SW RRHR
    Terri Jones503-671-9711 x36terri.jones@fda.hhs.govHFR-PA3515Consumer Safety Officer

    Field Electro-Optics Specialists and laser product contacts

    NamePhoneEmailMail StopPosition
    Emir Galevi781-729-5700 x724emir.galevi@fda.hhs.govHFR-NE480Engineer, WEAC
    Leo Lagrotte813-228-2671 x35leo.lagrotte@fda.hhs.govHFR-SE2585Electro-Optics Specialist, SER
    James E. Frye513-684-2700 x149james.frye@fda.hhs.govHFR-CE400Electro-Optics Specialist, CER
    Don Leeseberg210-541-9450don.leeseberg@fda.hhs.govRP-MOB 1075Consumer Safety Officer, SWR

    Winchester Engineering and Analytical Center contacts

    NamePhoneEmailMail StopPosition
    Brian Baker781-756-9701brian.baker@fda.hhs.govHFR-NE400WEAC Director
    Jim Cherniack781-756-9711james.cherniack@fda.hhs.govHFR-NE400Radiation Safety Officer
    Joe Matrisciano781-756-9705joseph.matrisciano@fda.hhs.govHFR-NE480Engineering Supervisor

    Headquarters contacts

    NamePhoneEmailMail StopPosition
    Mei-Ying, DFSR


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