Nanotechnology Medical

Health Care Bill The purpose of this work is to outline the legislative process and propose valuable new legislation. There are several learners objectives. The first is to understand the legislative process. The second is to be able to understand and identify gaps in the present regulatory environment. The third is to be able to gain an understanding of the wording of health care laws. There is a wide range of health care initiatives at the Federal level, including new drug protection, the Affordable Care Act and Medicare Part D.

A new law would need to address an area of weakness for these laws. One area where a new law could be beneficial is with respect to the governing of nanotechnology and biotechnology, which are currently governed under the FDA's approval process for medical devices (Crasto, 2014). Such approvals take a long time, because of the need for testing. However, the rapid pace of evolution for both biotechnology and nanotechnology means that in the time taken to secure approval, the technology could have experienced material change.

The bill proposed, with the assistance of the research companies involved in this technology, will allow for a more flexible and adaptive approval process, a unique stream for these products, so that should there be a change in the technology midstream in the testing process, that the testing process does not need to begin anew -- the new tests can be built on the old tests. Given the current political climate, the bill will need bipartisan sponsorship in order to get through a Republican-controlled House, a Democrat-controlled Senate and President.

The sponsor is typically someone from a state or district where the key industry players are located. It does not matter whether or not I voted for the individuals I am going to approach to champion this bill; they have no way of knowing if I voted for them, and I have to gather bipartisan support anyway. The champions will also be industry representatives and lobbyists who have the connections in Congress that can help me to pursue this bill. There is a pathway to implementing this bill.

The first is that the law needs to be drafted and passed. This occurs at the federal level, and it could take one or two years to make this happen, depending on the level of support. It is best to present a completed draft of the bill to the legislators being targeted as champions, so that they can take that draft directly to Congress with little delay (Walenta, 2010).

If the bill is voted and signed into law, the implementation process then moves to the FDA, which is the enforcement body for these standards. The FDA will need to implement these changes, but that is likely to take at least a year, and probably three or four years.

An entirely new stream for testing will need to be created, and the FDA will need to work with industry to understand how best to balance the needs of the industry with the needs of the American people to have safe medical care. The FDA will also need to hire more people to help this process run smoothly. As such, it is expected that the process will take some time to implement even once it becomes law.

As for the actual text of the law, most laws are rather lengthy, verbose documents. The Patient Protection and Affordable Care Act is 906 pages long. Working with that format, the following text can be added either in a new law or as an addendum to existing FDA laws. Sec. 1001. APPROVAL OF NANOTECHNOLOGY MEDICAL DEVICES (a) APPLICATION OF EXISTING APPROVALS PROCESS (1) The basic framework of the FDA approvals process for medical devices as per Sec.

1241 of the Food and Drug Administration Act is amended to allow for a special category of medical device approvals, for nanotechnology devices, using the definition of nanotechnology found in Sec. 0104-12 of this Act. (2) Where the technology tested has been altered due to innovation or improvement, the FDA shall provide a pathway for the altered or improved device to continue from with the approvals process, without the need to return to the beginning of said process.

The FDA shall write these provisions with the following considerations in mind: (i) That the altered version of the technology does not represent a material change in the functionality. (ii) That the altered.