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- FDA Issues UDI Proposed Rule, Roll-Out Expected in 2014
The Office of Management and Budget has approved the FDA's long-awaited proposed rule on a unique device identifier (UDI), clearing it for release by the agency. The rule, once implemented, will provide the cornerstone for a modern postmarket device surveillance program.
Seventh Annual FDA Inspections Summit on Sept. 19-21, 2012 in Bethesda, MD. Each year, the FDA makes adjustments to its inspection processes and policies. This year is no exception.Year after year, the crème de la crème of the industry make it their business to attend this conference and tap into the cumulative knowledge of an accomplished group of top officials from CDER, CDRH, CBER, the Office of Regulatory Affairs (and more). Register today to hear about breaking news directly from prominent FDA officials. That's why you can't afford NOT to attend the Seventh Annual FDA Inspections Summit.
- Report: PIP Case Highlights MHRA’s Need for More, Better Medical Device Data
While judging the Medicines and Healthcare products Regulatory Agency's (MHRA) response to the PIP silicone breast implant scandal basically sound, a new review by the UK Department of Health (DOH) finds the agency needs better access to information on devices to preclude similar safety scares in the future.
- Five Key Factors to Consider When Outsourcing Operations
Quality system regulations envision a risk-based approach to outsourcing operations capable of showing that all products and services obtained meet certain minimum requirements. These oversight requirements for managing an outsourced operation follow a logical cycle, from initial selection and use to postmarket feedback.
- Formalize Supplier Relationships to Reduce Liability Risks
As devicemakers work with increasing numbers of companies in the supply chain, their risks of liability rise, making it imperative they have contracts and auditing policies in place to avoid costly lawsuits, recalls and adverse publicity, a product liability expert says.