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Focus on the Intended Audience: The Public

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.

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Focus on the Intended Audience: The Public

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  1. Medical Imaging & Technology Alliance MITA Perspective on Establishing a Public Database for Device Labeling & PhotosCDRH Public MeetingApril 7, 2011

  2. 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

  3. 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

  4. Device Variety Requires FDA Flexibility

  5. 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

  6. MITA’s Broader ConcernsOperator 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

  7. MITA’s Broader ConcernsClearance 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.

  8. MITA’s Broader ConcernsResource 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

  9. Medical Imaging & Technology Alliance MITA Perspective on Establishing a Public Database for Device Labeling & PhotosCDRH Public MeetingApril 7, 2011

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