Office of Drug Safety

Office of Drug Safety, Center for Drug Evaluation and Research (CDER), Eood and Drug Administration, Silver Spring, Maryland, U.S.A. 

Adler, E.V. and Bums, M., Drug Recognition Expert (DRE) Validation Study, Final Report to Governor s Office of Highway Safety, State of Arizona, 1994. 

Karthik V. Pillai Division of Food Processing Science and Technology, Office of Food Safety, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, Bedford Park, IF, USA... 

J. H. Draize, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States Business Office, Bureau of Food and Drugs, Austin, Texas, Chap. Dermal Toxicity, Texas State Dept, of Health, 1959, pp. 46-48. 

BPT = Best Practicable (Control) Technology EPA - Environmental Protection Agency FDA = Food and Drug Administration FSIS = Food Safety Inspection Service IARC = International Agency for Research on Cancer NSPS = New Source Performance Standards OWRS = Office of Water Regulations and Standards PSES = Pretreatment Standards for Existing Sources PSNS = Pretreatment Standards for New Sources RfD Dose u.f. = Uncertainty Factor... 

EPA = Environmental Proection Agency FDA = Food and Drug Administration IARC = International Agency for Research on Cancer LDR = Land Disposal Restrictions NIOSH = National Institute for Occupational Safety and Health OERR = Office of Emergency and Remedial Response OSW = Office of Solid Wastes ... 

Fig. 1. An overview of the DCLD tier/triage flow chart Boxes 1, 2, and 3 are taken from the Office of Device Evaluation decision tree, which is routinely used to determine whether a product can be reviewed as a 510(k) and found substantially equivalent to a predicate (currently marked) device or whether the product must be handled as a fundamentally new product and submitted to a PMA review. Box 4 determines the novelty of the product in terms of analyte, matrix, and/or technology. If new issues of safety and effectiveness are raised, a highly novel product might require review as a PMA. If the issues of safety and effectiveness are not new but require high-level scrutiny, then a tier III review is warranted. Examples of products requiring a tier III review would include 1. Analyte troponin for diagnosis of MI (with creatinine kinase as the predicate) 2. Matrix sweat patches for drugs of abuse (with urine drugs of abuse tests as the predicate) and 3. Technology nucleic acid...

Joseph Hackett Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety, Rockville, Maryland, U.S. 

Ministry of Health, Scottish Home and Health Departments. Safety of Drugs. Final Report of the Joint Sub-Committee of the Standing Medical Advisory Committees. Her Majesty s Stationery Office, London, 1963. 

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