# Presentation: 268031

## CDRHSTAKEHOLDERS MEETINGProposed Radiological Health ProgramOctober 31, 2005

- Presented
- By
- Robert Britain
- National Electrical Manufacturers Association

## INTRODUCTION

- NEMA – largest U.S. trade Association representing U.S. electroindustry
- Diagnostic Imaging and Therapy Systems Division of NEMA represents over 95% of the market for x-ray imaging, CT, radiation therapy, MR, diagnostic ultrasound, nuclear medicine imaging and medical imaging informatics equipment.

## NEMA’s HISTORICAL INVOLVEMENT

- Provided congressional testimony for the RCHSA
- Interacted with BRH on the X-Ray Standard
- Interacted with TEPRSCC on the sun lamp and mercury vapor lamp standards
- Major role in reclassifying MRI from III to II
- Major role in developing Ultrasound 510(K) Guidance
- Hold periodic meetings with CDRH staff to review CT and Fluoro issues.

## NON-MEDICAL PRODUCTS IN NEMA’S PRODUCT SCOPE

- Lamps (includes)
- - Sun lamps
- - Mercury vapor lamps
- Arc Welding machines

## PROPOSED  RADIOLOGICAL HEALTH PROGRAM

- _General Comments:_
- NEMA supports concept of FDA Rad. Health Program to focus FDA resources on products/procedures with highest risk to public
- Agree on major program areas
- Use of international standards
- Efficient monitoring
- Focused education
- Research based on high priority questions

## PROPOSED RADIOLOGICAL HEALTH PROGRAM

- _Issues:_
- Standards
- FDA standards too expensive to develop and maintain
- Medical imaging technology is changing rapidly
- Referencing IEC standards is very tempting
- All imaging modalities are covered by IEC standards

## PROPOSED RADIOLOGICAL HEALTH PROGRAM 

- _Issues:_ (continued)
- 	  -	Industry/FDA should review IEC standards 	for appropriateness for enforcement
- 	  -	A legislative change to allow FDA to adopt 	standards might not allow administrative 	procedures to be circumvented i.e. publish 	proposed, comment period and publish final

## PROPOSED RADIOLOGICAL HEALTH PROGRAM

- _Issues:_ (Continued)
- Monitoring
- Agree on requiring only essential reports and essential information describing products
- Suggest eliminating 2579 Reports for replacement components – use only for new installations.
- Suggest exempting X-Ray equipment from Annual Report requirements, except for CT and fluoroscopy
- Agree on shift from product testing to quality systems audits/inspections.  NEMA does not now support the type testing concept.

## PROPOSED RADIOLOGICAL HEALTH PROGRAM

- _Issues:_ (Continued)
- Education
- Definite need for a credible consumer/patient (c/p) education program
- Most safety and use information reaches c/p through the press – which is not always balanced.
- The press coverage on medical imaging had become so unbalanced that NEMA developed www.medicalimaging.org

## PROPOSED RADIOLOGICAL HEALTH PROGRAM

- _Issues:_ (Continued)
- Research
- Agree, research based on highest priority questions
- Agree, research should have blessing of the Science Prioritization Oversight Committee

## PROPOSED RADIOLOGICAL HEALTH PROGRAM

- _How can NEMA and CDRH work together:_
- _Standards _– NEMA to develop list of relevant IEC standards for FDA – standards to which manufacturers certify.
- _Education _– NEMA to provide to FDA input into process of development of educational materials and will study the possibility of adding a special consumer/patient section to www.medicalimaging.org.

## PROPOSED RADIOLOGICAL HEALTH PROGRAM

- _Monitoring_ – FDA and NEMA – to revise manufacturing reporting requirements to provide only “essential” information, i.e. – eliminate unnecessary reports

## CONCLUSION

- 	NEMA believes the CDRH Radiological Health Program Plan is conceptually sound.
- 	NEMA is ready to work with FDA in developing this program.