The 510(K) that needs to be submitted is the Traditional. A Special is for modifications to products that already have 510(k) approval, so that does not apply in this case. An Abbreviated 510(K) applies when a product is approved for this process by the FDA. There is little explanation on the FDA website of what that means, or what the definitions of the terms it uses are. But with a device that does not have equivalence, there is little likelihood that with new technology this product would be eligible for the abbreviated FDA process.
The different types of documentation that need to be submitted along with the Traditional 510(K) can be found here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134572.htm
The decision letter is the final stage of the process, wherein the FDA informs the company of its decision about the device approval. There is no indication of how long the review process will...
Translating Biomedical Innovation / Mental Health and well being Managing Ideas: Commercialization Strategies for Biotechnology This article by Joshua and Scott Focuses on the commercialization aspect of biotechnology and stresses how important it is for innovators in the new and fast developing field of biotechnology to effectively forge collaboration with existing pharmaceutical market leaders in order to successfully create a new and strong value proposition for the healthcare sector. Biotech firms have
Medication Errors Since the research materials are provided to you by human beings, and may be based Medication errors pose a significant threat to patients. The results of medication errors vary from mild to deadly. No facility is immune from the possibility to drug errors, either through a fault of their own, or from suppliers or pharmacists that supply them. All medication errors must be reported to the Food and Drug Administration.
..for cleansing, beautifying, promoting attractiveness, or altering the appearance" while a drug is "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "intended to affect the structure or any function of the body of man or other animals" (Is it, 2002, FDA). Cosmetics thus alter the appearance of the individual and are aesthetic or hygienic in nature, while drugs promote health through wellness and disease
Patient and family education is essential especially with regards to eating habits. The patients should avoid excess fat in their diet as it contributes to high chances of contracting the disease (Bolen et al. 2010). The drug has, however, remained on the market in the U.S. The drug has been removed from European markets due to escalating concerns regarding safety. Obesity has considerable contribution to the number of preventable deaths
Organic Pet Store The legal and regulatory environment for an organic pet store is relatively straightforward, with limited regulations. All of the products must be approved by the FDA, which means that all suppliers need to go through this process (FDA, 2011). Food that is advertised as being organic must be certified as such, either through the USDA or the Oregon Tilth. No generic organic certification is allowed -- all products
Each of these consultative bodies is made up of ten to fifteen doctors and scientists with widespread knowledge about infectious illnesses, immunology and vaccine research. The statistics measured by these groups are wider than that looked at by the FDA. While the FDA looks at only when vaccines work and are safe, advisory bodies look at how much inoculations cost and how to best utilize them. While the FDA
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