Premarketing risk assessment

Source Guidance for Industry Premarketing Risk Assessment, May 2004, U.S. Food and Drug Administration, http//www.fda.gov/cber/guidelines.htm accessed May 20, 2004. 

Food and Drug Administration. Guidance for industry—Premarketing risk assessment, http / / www.fda. gov/ downloads/ Drugs/GuidanceComplianceRegulatory Information/Guidances/UGM072002.pdf, 2005. Accessed January 10,2014. 

FDA (2005) Guidance for Industry. Premarketing risk assessment. Available at http //www.fda. gov/downloads/regulatoryinformation/guidances/ucml26958.pdf. Accessed 24 Nov 2015... 

The E.U. s European Food Safety Authority (EFSA) is tasked with providing scientihc opinions regarding feed and food to the European Commission (EC) and other European legal entities. Risk assessment for FCSs falls within EESA s responsibility. Similarly to the U.S., the European FCM regulation requires premarket safety assessments of FCS. However, unlike in the U.S., not all FCSs are... 

Suspicions were expressed in the Mealey Publication s Drug and Medical Device Report that the Lyme disease vaccine LYMErix could cause an incurable form of autoimmune arthritis. It was hjrpothesized that blood concentrations of OspA after three doses of vaccine place vaccinees classified by genetic type HLA-DR4-I- at risk of developing treatment-resistant Ljme arthritis. The premarket trials for the vaccine were assessed by an independent advisory committee, which found no link between Ljme disease immunization and autoimmune arthritis (10). However, the committee stressed the need for long-term surveillance and further studies in those over 70 years and in children, and the effect of the vaccine in patients with chronic arthritis the possible development of autoimmunity deserves further study (11). After licensing of the vaccine, more than 1 rmlfion Americans received it and no unusual adverse effects were reported to the manufacturer (10). 

For those readers not familiar with the premarket requirements for medical devices it is generally, but not always, true that a Class I device may be marketed without prior FDA clearance. A Class II device typically requires prior FDA clearance, known as a 510(k). This is usually true as long as the device can be shown to be substantially equivalent to a device previously cleared by FDA for the same indicated use, or for which there is a preamendment device with similarities. The requirement to continuously compare a new product to one on the market in 1976 was modified in 1990 with the Safe Medical Devices Act (SMDA). The regulations have been modified to focus on whether devices are either considered to be safe and thus manageable with special controls , or whether their safety might be an issue if certain unanticipated risk factors have evolved with expanded use. For this reason it is imperative to conduct an early regulatory assessment for any new product, no matter how similar it may seem to an existing product. 

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