1 Medical Imaging & Technology Alliance MITA Perspective on Establishing a Public Database for Device Labeling & Photos CDRH Public Meeting April 7, 2011

Focus on the Intended Audience: The Public FDA should evaluate repository information requirements based on helpfulness to patients and providers –Only information directly beneficial to these groups should be considered for inclusion FDA should focus first on consumer products before considering expansion to professionally-operated prescription devices 2

Parameters Necessary for Success MITA appreciates FDA’s promise to exclude all propriety information, but the owners of the intellectual property need to have the final say on what constitutes ‘proprietary’, not regulators Any repository information submission requirements should mirror existing submission requirements and be confined to information already made publicly available by manufacturers –MITA appreciates FDAs plan to exclude operator and service manuals from the online database 3

Device Variety Requires FDA Flexibility 4

Parameters Necessary for Success Many medical imaging devices are large systems Component parts are often housed in separate rooms Best solution is to use only photos already made public by manufacturers 5

MITA’s Broader Concerns Operator Decision Making Impact How will promoting the repository as a source for device operators impact decision making in the clinical setting? –Manufacturers’ extensive operator support systems exist to ensure operators have access to the information they need at all times –Manufacturers do not want an online database to substitute for interpersonal communication between operators and support professionals –This raises liability concerns for both manufacturers and the Agency 6

MITA’s Broader Concerns Clearance Process Impact How will the repository’s information requirements impact the clearance and approval processes? –FDA should clarify that this initiative will not mingle with the clearance and approval processes or somehow create new burdens or delays –MITA would strongly oppose requiring final labeling to be submitted in advance of or as a condition for clearance. 7

MITA’s Broader Concerns Resource Burden Will devoting scarce resources to designing, establishing, and maintaining this new repository impact the Agency’s clearance and approval performance? –Screening every labeling change for every cleared product would be an enormous new mission for FDA –If updates are required for even small changes, this initiative will require substantial time and effort from both manufacturers and FDA –FDA should focus its resources on its clearance and approval efforts 8

9 Medical Imaging & Technology Alliance MITA Perspective on Establishing a Public Database for Device Labeling & Photos CDRH Public Meeting April 7, 2011