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| National Drug Code - Identifies the labeler, vendor, product and trade package size |
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| National Institutes of Health |
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| Notice of Proposed Rule-Making |
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| Not Substantially Equivalent - designation for device that does not qualify for 510(k) clearance. May require a PMA. |
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| Official Action Indicated - indicated on FDA form 483 following inspection |
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| Office of Biostatistics and Epidemiology (CBER) |
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| Office of Blood Research and Review (CBER) |
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1) Office of Commissioner (FDA)
2) Office of Compliance (CDER, CDRH) |
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| Office of Criminal Investigation (ORA) - advises and assists the associate commissioner and other key FDA officials on policy development, established regulations and criminal matters |
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1) Office of Drug Evaluation (CDER)
2) Office of Device Evaluation (CDRH) |
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1) Office of Drug Evaluation (CDER)
2) Office of Device Evaluation (CDRH) |
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| Office of Enforcement (ORA) - directs and develops FDAs activities for regulations, monitors compliance activities for uniformity, reviews all proposed legal actions for adherence to regulatory policy and enforcement objectives, and provides support to the compliance branches located in field offices |
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| Office of Epidemiology and Biostatistics (CDER) |
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| Official Establishment Inventory - compilations of frims FDA has inspected, frims that have shipped products to the US, as indicated by the OASIS database, and firms that have listed as part of the agency's drug listing program. |
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1) Office of Public Affairs
2) Office of Premarket Approvals (CFSAN) |
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| Office of Regulatory Affairs - lead office for all FDA field activities |
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| Occupational Safety and Health Administration |
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| Office of Vaccines Research and Review (CBER) |
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| Product Development Protocol |
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| Prescription Drug User Fee Act (1992) |
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1) Package Insert
2) Principal Investigator |
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| Premarket Approval Application - marketing application required for Class III deivices |
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| Premarket notification - 510(k) for Class I and II devices |
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| Post-marketing surveillance - ongoing monitoring of hte safet of approved drugs. May include Phase IV studies and AE reporting |
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| Points to consider - guidance published by FDA |
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| Points to consider - guidance published by FDA |
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| Qualtiy Systems Inspection Technique |
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| Quality System Regulation (June 1997) includes requirements related to the methods used in, and the facilities and controls used for desigining, manufacturing, packaging, labeling, storing, installing and servicing of medical devices intended for human use |
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