Title: Current Good Manufacturing Practice (CGMP) Regulations
Source: U.S. Food & Drug Administration
Summary: The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
Title: FDA Regulation of Medical Devices
Source: Congressional Research Service
Summary: This report is intended to provide a broad overview of FDA medical device regulation, and as such, it may not describe every applicable device requirement.
Title: Medical Device Reporting (MDR): How to Report Medical Device Problems
Source: U.S. Food & Drug Administration
Summary: Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices. This report covers reporting programs and requirements.
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