Question 25

The historical developments associated with the regulation of medical devices highlight several influential forces. Foremost, during the 1960s, the FDA faced legal impediments over its discretion to exercise authoritative powers. The federal institution did not have any guarantees that Congress would not undermine the actions it took. Congress was responsible for determining how FDA should enforce the 510(k) clearance process. The initial Medical Device Amendment of 1976 was nearly double the size of the FFDCA. Subsequent changes in the text highlights instances of congressional micromanagement. Congress employs such an approach to ensure that executive branches remain under the President’s control.

Since its inception, the FDA has never operated within a political vacuum. The federal institution is subject to political and legal scrutiny throughout its operations. Due to changing political ideologies and regimes, regulatory policies covering FDA’s mandates tend to change from one president to the other. The different congressional committees can use oversight hearings, committee reviews and investigations to force the FDA into implementing policies and actions that reflect their political interests. Regime changes and its effects on the judicial system profoundly affect the execution of the medical-device statute.

Lastly, a historical analysis of FDA’s performance since its establishment shows a gap between congressional mandates and federal budgeting for related enforcement. Congress has established the reputation of consistently underfunding the FDA. The appropriation process for resources is often plagued with socioeconomic and political pressures, such as fiscal policy, competing public demands and changing government agendas. Therefore, it is often the case that funding does not measure up to the mandates and goals set by Congress. Even the most detailed and well envisioned legislations can become impractical with insufficient resources.

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