Questions
1. What is the procedure for the approval of a medical device?
The FDA's Centre for Devices and Radiological Health executes this mandate. They have the final say on who manufactures, repackages or imports medical devices for use in the US. The medical devices are grouped in classes: I. II and III. These classes depend on the need for controls, exemptions and premarket approval. There is an increasing severity of the regulation procedure from class I to Class III (FDA, September 2014).
The following are steps that are followed in the registration and regulation procedure. First, the sponsor (manufacturer or importer) must register their company with the FDA. The registration information is subject to yearly review. Secondly, the manufacture must list their device with the FDA. The list requires the following: manufactures, contractors, repackages, specification developers among others (FDA, 2014 August).
Third, the devices that require a Premarket Notification 510(K) must file the same. The notification must prove that the device is a substantial equivalent to one already in use in the US. Premarket approval will then be undertaken for the class II devices. This process involves testing and acquisition of information related to the preclinical and clinical trials of the device (FDA, 2014 August).
2. The concerns that attributed to the introduction of biotech food products in the market are centered around the effects on human beings and on animal wellbeing as well as the effect on the ecosystems. On the fringe of these concerns is the violation of religious custom. The tradeoff between benefits and detriments has been the weights on the scale in legislation. The public health concerns raised include the fear that the introduced genes may cause pathologies and allergies in humans in the form increased toxin levels, altered pollen etc. consumer sovereignty depends on the facts being presented as a whole hence the clamor for the labeling of food products as GMOs. The inclusion of foreign genes raises religious questions as to whether consumption of gene product form a forbidden organism is equivalent to consumption of the said organism. There is evidence that the enhanced crops may have detrimental effects to other organisms e.g. the BT pesticide and the monarch butterfly study (Vogt & Parish, 2001 January)
3. Food additives are not the same. According to the FDA, any substance that is expected to be a constituent of food is subject to premarket approval. The exceptions to this rule are known as GRAS (Generally Recognized As Safe) products. Food additives aere classed according to the intended effect they impart in the food. These include technical effects, and color changes. Technical effects of food additives include preservation, sweetening, flavor enhancing, nutrients, stabilizers and emulsifiers among others. There exists a decision tree to help in making the decision whether the ingredients are of sufficient purity and comply with the standards (FDA 2014a: FDA 2014 b). There is need to pass food and supplement laws to bridge the gaps that are left in legislation. Some companies have been found to market herbal medicine in the US under the guise of dietary supplements. These is attributable to the ambiguity in the definition of compositions of food additive, supplements and herbal medicine (Jiang, 2009)
References
FDA. (2014 September). Classify Your Medical Device. Retrieved form http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyY ourDevice/default.htm
FDA. (2014 August). Overview of Device Regulation. Retrieved from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/
FDA. 2014a. Food Additives & Ingredients. Retrieved from http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/
FDA. 2014b. Overview of Food Ingredients, Additives & Colors. Retrieved form http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm0 94211.htm#types
Jiang, T. (2009). Re-thinking the dietary supplement laws and regulations 14 years after the Dietary Supplement Health and Education Act implementation. International journal of food sciences and nutrition, 60(4), 293-301.
Vogt, D. U., & Parish, M. (2001, January). Food Biotechnology in the United States: Science, Regulation and Issues. Congressional Research Service, Library of Congress.
