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	robertj.doyle@fda.hhs.gov	Chief, Electronic Products Branch
   Dr. Helen Barr	301-796-5713	helen.barr@fda.hhs.gov	Director, DMQRP
   Sean Boyd	301-796-5895	sean.boyd@fda.hhs.gov	Deputy Director, DMQRP
   Nancy Bennaugh	301-796-6642	Nancy.bennaugh@fda.hhs.gov	Program Analyst
   Daniel Hewett	301-796-5864	daniel.hewett@fda.hhs.gov	Consumer Safety Officer, laser products
   Dan Kassiday	301-796-5865	daniel.kassiday@fda.hhs.gov	Engineer, cabinet, industrial, analytical, security x-ray products
   George Kraus	301-796-5866	george.kraus@fda.hhs.gov	Consumer Safety Officer, TV and microwave oven products, imports
   L. Dale Smith	301-796-5868	l.smith@fda.hhs.gov	Consumer Safety Officer, laser light show products
   Cory Tylka	301-796-5869	corinne.tylka@fda.hhs.gov	Consumer Safety Officer, medical laser products
   Varsha Savalia	301-796-5867	varsha.savalia@fda.hhs.gov	Consumer Safety Officer, sunlamp and UV and laser products
   Sharon Miller	301-796-2471	sharona.miller@fda.hhs.gov	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	Ilko.ilev@fda.hhs.gov	Laser technology expert
   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
   Karen Smallwood	615-366-7823	karen.smallwood@fda.hhs.gov	HFR-SE350	Consumer Safety Officer
   Rachel Evans	312-596-6518	rachel.evans@fda.hhs.gov	HFR-CE25	Consumer Safety Officer
   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	Consumer Safety Officer

   Field Electro-Optics Specialists and laser product contacts

   Name	Phone	Email	Mail Stop	Position
   Emir Galevi	781-729-5700 x724	emir.galevi@fda.hhs.gov	HFR-NE480	Engineer, WEAC
   Leo Lagrotte	813-228-2671 x35	leo.lagrotte@fda.hhs.gov	HFR-SE2585	Electro-Optics Specialist, SER
   James E. Frye	513-684-2700 x149	james.frye@fda.hhs.gov	HFR-CE400	Electro-Optics Specialist, CER
   Don Leeseberg	210-541-9450	don.leeseberg@fda.hhs.gov	RP-MOB 1075	Consumer Safety Officer, SWR

   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 Cherniack	781-756-9711	james.cherniack@fda.hhs.gov	HFR-NE400	Radiation Safety Officer
   Joe Matrisciano	781-756-9705	joseph.matrisciano@fda.hhs.gov	HFR-NE480	Engineering Supervisor

   Headquarters contacts

   Name	Phone	Email	Mail Stop	Position
   Mei-Ying Li	301-796-5903	meiying.li@fda.hhs.gov	ELEM-3019	ORO, DFSR