Implications in Rural Health Care

Medical Technology: Implications of

Regulation in Health Care

Medical Technology: Implications of
Regulation in Health Care
    There is an ongoing debate about how much influence the government should have in health care (Laureate Education, Inc., 2010). Lines are divided in the middle whether government should be involved in health care and if so, how much. According to Getzen (2013) “the most fundamental function of government is to maintain law and order” (p. 320). If the government plays a role in health care, then it means that the American people would have support should they need to purchase a health care plan but do not have the ability to pay for it.
    Government involvement also means providing universal health care to all. On the other hand, there are some who believe that the government poses more of a problem rather than being the solution. The numerous regulations that health care is governed by is overwhelming. Almost every aspect of the health care field is administered by one regulatory body or another (Field, 2008). The purpose of this paper focuses on the regulation of medical technology; issues or concerns from regulation; proposals to modify regulation and who are most affected by these proposals.
FDA Regulation: Medical Technology
    Medical technology serves several purposes such as diagnosing, monitoring or treating diseases and medical conditions affecting humans. The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regulate firms that import or manufacture medical devices sold in the United States (FDA, 2014a). Each device, under federal law, are assigned to a regulatory classes; Class I, Class II, and Class III (FDA, 2014b).
    The FDA has authority to ensure the safety and effectiveness of life-saving medical devices while protecting the public from deceptive devices (FDA, 2014b). The new medical devices that are more effective and cost efficient can drive health care and...