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Section 360c of Title 21 divides devices into three classes by the controls needed to provide reasonable assurance of safety and effectiveness. Class I devices are adequately controlled by general controls. Class II devices require special controls such as performance standards or postmarket surveillance. Class III devices are those for which controls are insufficient and which are high risk or life-sustaining, and they require premarket approval.
Direct shipment to consumers is permitted by the receiving state, not by federal law, and typically requires a direct shipper permit issued by that state. Common conditions include volume caps per household, adult signature on delivery, marking of the shipping container, remittance of the state's excise and sales taxes, periodic reporting, and use of an approved carrier. Under Granholm a state may not allow in-state producers to ship while forbidding out-of-state producers from doing the same.
The Supreme Court held in Aérospatiale that the Evidence Convention does not displace the Federal Rules for discovery sought from a party subject to the court's jurisdiction, and that no first-resort requirement applies. Where compliance would violate foreign law, courts apply a comity analysis weighing the importance and specificity of the request, where the material originated, the availability of alternatives, and the competing national interests.
Under 28 U.S.C. 1254 cases in the courts of appeals may be reviewed by writ of certiorari granted on the petition of any party, and under 28 U.S.C. 1257 final judgments of the highest court of a state may be reviewed where a federal question is presented. Review is discretionary. The considerations governing it include conflict among the courts of appeals, conflict with a state court of last resort, a departure from the accepted course of proceedings, and an important unsettled federal question.
Under the uniform custody jurisdiction act, adopted state by state and renumbered into each state's code, a court has temporary emergency jurisdiction where the child is present in the state and has been abandoned, or where protection is necessary because the child, a sibling or a parent is subjected to or threatened with mistreatment or abuse. The order lasts only until a court with ordinary jurisdiction acts, and the two courts must communicate.
An employee of a treaty enterprise qualifies for the classification where the employee holds the nationality of the treaty country and either performs duties of an executive or supervisory character or possesses special qualifications essential to the efficient operation of the enterprise. Executive and supervisory claims are tested against control and responsibility. Essentiality is tested against a list of factors, and the regulation treats some essential skills as temporary by nature.
Rule 21F-17 provides that no person may take any action to impede an individual from communicating directly with Commission staff about a possible securities law violation, including by enforcing or threatening to enforce a confidentiality agreement. The commodities rules contain a parallel prohibition. Section 3730(h) separately entitles an employee, contractor or agent who suffers retaliation to reinstatement, double back pay with interest and special damages.
The export rules impose prohibitions that operate independently of an item's classification. Restricted party lists identify entities to which specified transactions require authorization or are denied outright. End-use prohibitions in 15 CFR Part 744 apply where an exporter knows or has reason to know that an item is intended for a prohibited use or user. Knowledge includes awareness of a high probability, so unresolved warning signs can supply the required state of mind.
The uniform custody jurisdiction act, enacted separately by each legislature, directs courts to treat a foreign country as if it were a state for jurisdiction, recognition and enforcement. A determination made under factual circumstances in substantial conformity with the act's jurisdictional standards must be recognized and enforced, provided reasonable notice and a hearing were given. A court need not apply the act where the foreign custody law violates fundamental human rights.
A foreign money judgment that has been recognized is enforceable in the same manner as a judgment of a sister state. Execution follows the procedure of the state where the enforcing court sits, and the creditor must domesticate the judgment separately in each state where assets are located. Post-judgment discovery is broad and reaches third parties. Currency conversion and interest are governed by the forum's own rules rather than by the rendering court's.
Escrow places subscription funds with a neutral holder until stated conditions occur, protecting an investor against the risk of a failed filing or an unraised offering. Because capital held in escrow has not been placed at the enterprise's disposal, it is not yet exposed to loss and does not begin the sustainment period or generate jobs. Release triggers have therefore moved earlier, and the terms of the agreement decide who bears the risk in the gap.
Federal Rule of Evidence 804 makes certain hearsay admissible only once the declarant is shown to be unavailable. Rule 804(a) defines unavailability through five grounds: privilege, refusal despite an order, lack of memory, death or infirmity, and absence the proponent could not overcome. Rule 804(b) then admits former testimony, statements made under a belief of imminent death, statements against interest, statements of family history, and statements against a party that caused the absence.
