In addition to the development of broadly applicable research tools that address the core technical challenges in proteomics, unique constraints in two subordinate areas merit special attention.
In addition to the preceding working definitions, where applicable, we utilize the National Institutes of Health (NIH) definitions [ 13] for both clinical and translational research, as follows: Clinical Research Researchh with human subjects that is: Patient-oriented research.
However, sustainability activities will entail extra costs in addition to the costs of implementation and, where applicable, the costs of the innovation itself.
In addition to the need for tailored interventions, several interventions applicable to all regions and respondent groups were identified.
The language of §360k demonstrates congressional intent that the MDA pre-empt "any requirement" by a State that is "different from, or in addition to," that applicable to the device under the FDCA.
If §360k's language is given its ordinary meaning, it clearly pre-empts any state common law action that would impose a requirement different from, or in addition to, that applicable under the FDCA--just as it would pre-empt a state statute or regulation that had that effect.
These requirements are in addition to other applicable protections for the research.
There is still a hierarchy -- an executive team runs the company in addition to (if applicable) an elected board of directors to oversee governance and so on -- but the measurement of success is vastly different.
The person may also be mentioned by name in the prayers of the faithful in addition to recitation of the applicable collect.
Because the statutory language does not indicate that a "requirement" must be "specific," either to pre-empt or be pre-empted, I conclude that a state common law claim is pre-empted if it would impose "any requirement" "which is different from, or in addition to," any requirement applicable to the device under the FDCA.
I conclude that a fair reading of §360k indicates that state common law claims are pre-empted, as the statute itself states, to the extent that their recognition would impose "any requirement" different from, or in addition to, FDCA requirements applicable to the device.
