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