Legal requirements reporting

If your report Involves a serious adverse event With a device and It occurred in a facility outside a doctor s office, that facility may be legally required to report to FDA and/or the manufacturer. Please notify the person in that facility who would handle such reporting. 

A description of any additionai records or reports that may be maintained above those legally required... 

All adverse events with medical devices of which the manufacturer becomes aware must be recorded. The detailed legal requirements in relation to recording and reporting are, curiously, more onerous in relation to MDs than AIMDs. However, the Commission s guidance is that they should be treated the same in practice. In general, a manufacturer of general medical devices should report, and a Member State record and evaluate,... 

Every laboratory should have an internal accident-reporting system. This includes provisions for investigating the cause of an injury as well as any potentially serious incident that does not result in injury. The primary aim of such investigations should be to make recommendations to improve safety, not to assign blame for an incident. Local legal regulations may require reporting procedures for accidents or injuries. 

Describe the legal authority of public health agencies to take action to protect the community from threats, including isolation, quarantine, and required reporting and documentation. 

Since October 1973, FDA regulations require that all U.S. ophthalmic ointments be sterile. This legal requirement was a result of several surveys on microbial contamination of ophthalmic ointments, and followed reports in Sweden and the United Kingdom of severe eye infections resulting from use of nonsterile ointments. In its survey published in 1973, the FDA found that of 82 batches of ophthalmic ointments tested from 27 manufacturers, 16 batches were contaminated, including 8 antibiotic-containing ointments. The contamination levels were low and were principally molds and yeasts... 

Table 5-1 lists the number of facilities in each state that manufacture or process coal tar creosote, the intended use, and the range of maximum amounts of creosote that are stored on site. The data listed in Table 5-1 are derived from the Toxics Release Inventory (TRI) (TRI99 2001). Only certain types of facilities are legally required to report therefore, this is not an exhaustive list. 

A final report should be forwarded to the Health Authorities after the recall has been completed for further evaluation and action. Where legally required, the competent health authorities are also supplied with a report on the recall operation. 

Step 9. If the candidate raw material is approved and the supplier is a new suppher, the EHS Manager is responsible for notifying the Responsible Care Supplier Audit Team of the need for a new supplier audit as required in PP.20.4. (PP.20.4 should include the protocol for the conduct of a new supplier audit. The audit involves a review of the supplier s operations for operational capability, compliance with legal requirements, and Responsible Care Codes. The audit report may decline use of the supplier, accept the supplier, or accept the Supplier subject to designated corrective actions.)... 

Compliance and reporting measure environmental performance, conduct regular environmental audits and assessments of compliance with company requirements, legal requirements and with the ICC principles as well as providing this information to the board of directors, shareholders, employees, authorities and the public. 

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