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In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) expanded the FDA's authorities and strengthened the Agency's ability to safeguard and advance public health. Among other authorities, FDASIA permitted FDA to publish regulations establishing a Unique Device Identification (UDI) system for medical devices.
Manufacturers and importers are to prepare for the application of such requirements and to report medical devices intended for human use manufactured or imported by them. Panel appointments shall consist of members with adequately diversified expertise in such fields as biological and physical sciences, clinical and administrative medicine ...
Calibration, quality control, and proficiency testing materials; Test system troubleshooting and equipment maintenance; Interpretation and judgment; Centers for Medicare and Medicaid Services (CMS) has the primary responsibility for the operation of the CLIA Program. Within CMS, the program is implemented by the Center for Medicaid and State ...
[code of federal regulations] [title 21, volume 5] [revised as of april 1, 2015] [cite: 21cfr314.50] title 21food and drugs chapter ifood and drug administration department of health and human services subchapter ddrugs for human use part 314 applications for fda approval to market a new drug
Safe Medical Device Amendments of 1990; Long title: An Act to amend the Federal Food, Drug, and Cosmetic Act to make improvements in the regulation of medical devices, and for other purposes.
Nationally Recognized Testing Laboratory is the term used by the United States Occupational Safety and Health Administration to identify third-party organizations that have the necessary qualifications to perform safety testing and certification of products covered within OSHA and each organization's scopes.