Inspection and Field Testing of Radiation-Emitting Electronic Products - Part: VI - References, Attachments, and Program Contacts
PART VI - REFERENCES, ATTACHMENTS AND PROGRAM CONTACTS
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References
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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) -
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
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FDA Web Sites
Field Accomplishments and Compliance Tracking System (FACTS) — FDA Intranet Only
Electronic Product Radiation Control home page
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Attachments
- Attachment A – Classification table for reporting and quality control testing program Non-Compliant Items (common to all EPRC inspections and field tests)
- Attachment B – Specific Instructions for Laser Product Inspections and Tests
- Attachment C – Specific Instructions for Sunlamp Product Inspections and Tests
- Attachment D – Specific Instructions for Cabinet X-Ray Product Inspections and Tests
- Attachment E – Specific Instructions for Television Product Inspections and Tests
- Attachment F – Specific Instructions for Microwave Oven Product Inspections and Tests
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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