# Presentation: 499847

## CDRH UpdateNEMA Diagnostic Imaging and Therapy Systems24th Annual Meeting

**CDRH Update****NEMA Diagnostic Imaging and Therapy Systems****24****th**** Annual Meeting**

- David W. Feigal, Jr., M.D., M.P.H.
- Director
- Center for Devices and Radiological Health
*Rosslyn, VA, Sept 27, 1999*

## CDRH and the Imaging Industry 

- Registration and Listing section of the Office of Compliance:
- 250 manufacturers of  Medical Imaging equipment

## Applications in Fiscal Year 1999

- Approximately 400 applications submitted for imaging equipment.
- 6 of these were for digital radiographic equipment.
- 2 of these were for digital mammography.
- 4 PMAs for digital imaging have been approved this year.

## Standards

- Long history of collaboration with NEMA
- The original diagnostic x-ray standard was largely based upon NCRP (National Council on Radiation Protection) report and industry standards.
- Reclassification of magnetic resonance imaging devices derived from collaborative work on NEMA standards.
- The precursor to the abbreviated 510(k) was developed through NEMA/FDA negotiation (1993).

## Standards

- Current Issues:
- For most standards, it is not feasible for testing to be conducted on a prototype – rather, testing is done on production units against the standard at the time that the declaration is submitted to FDA.
- An abbreviated 510(k) allows a declaration of conformity to the standard with no need for actual review of underlying data.
- During development of the FDA Modernization Act, the idea of “prospective” standard certification was introduced, an approach now under consideration by FDA.

## Standards

- Long history of collaboration with NEMA
- NEMA perceives the FDAMA use of standards as a direct conflict with its traditional methods but the policy paper being developed will seek to provide a role for standards in multiple regulatory pathways.

## Why aren’t declarations of conformity to standards (under FDAMA) being used?

- Several barriers have been identified:
- Test data is needed before premarket submission ?
- Too few recognized standards exist ?
- Fear of inspections by the Agency ?
- There is no clear incentive to balance risk ?
- The perception remains that reviewers will still request data and not rely on standards ?

## Standards: The Issue of Test Data

- FDA will give it further consideration.
- This should be implemented with a minimum of disruption
- For our reviewers
- For industry.
- E.g., “skinny” 510(k)s for imaging devices would be unchanged.
- It is desired that existing policy and procedures be used to accomplish the goal.

## Standards

- What you can do!
- Get involved to save time, money, effort.
- Tell us what standards need to be recognized.
- Tell standards development organizations what standards need to be developed and participate.
- Tell us how to make the process smoother and more efficient.

## Guidance

- In 1999, four FDA imaging equipment guidance documents have been issued:
-  Guidance for Submission of 510(k)s:
- for Solid State X-ray Imaging Devices.
- for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems.
- for Magnetic Resonance Diagnostic Devices.
- for Radionuclide Dose Calibrators.

## Digital Mammography 

- Mammography is a preamendment (Safe Medical Devices Act of 1976) technology which continues to undergo tremendous improvement.
- 25 million mammograms are performed nationwide annually with significant health consequences for this large population.

## Digital Mammography 

- Therefore, it is imperative to assure that digital mammography is at least equal to analog, which has demonstrated clinical benefit.
- A false positive may result in unnecessary biopsy while a false negative may result in delayed cancer diagnosis.

## Digital Mammography 

- Clinical data: How much is needed?
- At the issuance of 1996 guidance on mammography, “agreement studies” were thought feasible
- However, the results of the studies leave open the question of whether digital images will result in more false positive biopsies
- Clinical Screening studies could require as many as 30,000 or more patients.

## Digital Mammography 

- Would a PMA be a more flexible approach than a 510(k)?
- The PMA approach offers an alternative since a small study can be conducted preapproval followed by a large, definitive study postapproval.
- The recently issued letter to manufacturers of digital mammography technology refers to this balance of pre- and postmarket data as mandated by FDAMA.

## Digital Mammography 

- Are there other alternatives ?
- A strategy whereby a joint screening study (ie., multiple manufacturers) could be conducted under the auspices of a third party such as NEMA ?
- Are there opportunities to combine the data collection from the MQSA program to assess the impact of new imaging technology?
- Comments from NEMA are welcomed as the FDA policy on digital mammography is developed.

## Fetal Ultrasound Monitors

- “Keepsake” videos of the fetus.
- Ultrasound is a Class II prescription medical device.
- A letter to manufacturers in 1994 explained that fetal ultrasound for souvenir purposes is not approved and is an unnecessary exposure to radiation.
- FDA is aware of about 10 locations per year where keepsake ultrasound videotaping occurs.
- One seizure occurred in 1997.
- This is a cottage industry involving registered sonographers and becomes a practice of medicine issue.

## People Scanners 

- People scanners are not medical devices but are handled strictly as radiological products.
- These products screen people for contraband and weapons and are used primarily in prisons and some international airports.
- The issue of exposure to ionizing radiation for nonmedical purposes is monitored by CDRH.
- At the annual meeting of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) recently, recommendations made there in 1998 were further discussed.

## People Scanners 

- TEPRSSC Recommendations:
- registration of the scanners with the state;
- operator training in radiation safety; and
- labeling of scanners as x-ray emitting.
- A letter will be issued by CDRH to manufacturers encouraging implementation of these recommendations.
- Instead of a federal mandatory standard, we convened an ANSI consensus standard work group to include FDA, industry, states, and users.

## People Scanners 

- CRCPD (the Conference of Radiation Control Program Directors) has passed a resolution that scanners only be used if alternative does not exist.
- The newly formed CDRH Radiological Health Council will have people scanners on its agenda as a crosscutting issue.

## HCFA

- CDRH will work proactively with the Health Care Financing Administration in meetings with industry.
- More transparent processes
- Attempt to shorten unnecessary delays from a ‘serial’ instead of ‘parallel’ evaluation process
- Attempt to avoid redundant requirements

## Our Website:

- www.fda.gov/cdrh