Statutory provisions

Two statutory provisions of Tide 21 govern the introduction of new medical devices into the marketplace. Section 515 estabHshes a premarket approval appHcation (PMA) containing data and information demonstrating the safety and effectiveness of a device. Section 510(k) estabHshes a premarket notification process. Under this process, a manufacturer is required to file with the EDA, 90 days before a new device is to be marketed, a premarket notification demonstrating that the device in question is substantially equivalent to a device that was on the market before enactment of the 1976 Amendment and therefore marketable without formal EDA approval. 

Contract carriers generally are not held to the same standard of HabiHty as common carriers because they are considered ordinary for-hire bailees and, therefore, are Hable only for their failure to exercise a reasonable degree of care for goods in their custody or possession, although such HabiHty may be varied by the contract. However, motor carriers providing service under contract are held to the same HabiHty standard appHcable to common carriers unless the statutory provisions imposing the standard are waived in the contract. 

The transportation of chemicals is dierefore highly regulated. In addition to general transport legislation numerous statutory provisions govern die carriage of hazardous substances by air, road, rail and sea. These tend to address die need for ... 

Having carried out an inspection of the works, the inspector has powers under Section 21 to serve an improvement notice if, in his opinion, a person is contravening one or more of the relevant statutory provisions, or has contravened one or more of those provisions in circumstances that make it likely that the contravention will continue or be repeated. The person concerned then has a duty to remedy the contravention or as the case may be, the matters occasioning it within such a period as may be specified in the notice. 

The following sections include the relevant sections of the complete Act and indicate those parts of the legislation within the different plant categories to which the inspections provided by the independent engineering inspection companies will conform. It should, however, be appreciated that while the inspections provided will fulfill the statutory requirements for inspection, the actual responsibilities under the various Acts to conform remains the responsibility of the plant owner/user. It must be appreciated that the interpretation of any Act is a matter for the local Health and Safety Inspectorate, who should be consulted at all times if doubt exists as to whether any item of machinery and plant requires inspection to comply with a statutory provision. 

This Act has been much amended and now forms a relevant statutory provision for the Health and Safety at Work, etc. Act 1974. Originally it provided for the registration and control of certain classes of chemical works. The Act has now been amended and the classes of premises, the scheduled works , are now included in the Health and Safety (Emission into Atmosphere) Regulations 1983 (amended 1989). There are 62 main categories of works, and in some cases only certain processes within a category are covered ... 

Prosecute any person who may be contravening a relevant statutory provision instead of (or in addition to) serving a notice. 

The Safe Drinking Water Act (SDWA), enacted in 1974 to assure high-quality water supplies through public water system. The act is truly the first federal intervention to set the limits of contaminants in drinking water. The 1986 amendments came two years after passage of the Hazardous and Solid Waste Amendments (HSWA) or the RCRA amendments of 1984. As a result, certain statutory provisions were added to these 1986 amendments to reflect the changes made in the underground injection control (UIC) systems. 

The central purpose of CERCLA is to provide a response mechanism for cleanup of any hazardous substance released, such as an accidental spill, or of a threatened release of a hazardous substance (Nordin et al., 1995). Section 102 of CERCLA is a catchall provision because it requires regulations to establish that quantity of any hazardous substance the release of which shall be reported pursuant to Section 103 of CERCLA. Thus, under CERCLA, the list of potentially responsible parties (PRPs) can include all direct and indirect culpable parties who have either released a hazardous substance or violated any statutory provision. In addition, responsible private parties are liable for cleanup actions and/or costs as... 

It is a clear ethical principle that the privacy of the individual should be respected and maintained. The law too, both in common law (i.e. judge-made law) and through certain statutory provisions (specifically Member States implementation of the 1995 Directive on the protection of personal data 95/46/EEC)... 

Deletes the obsolete statutory provisions relating to labelling of 17 listed habit-forming drugs. 

Any reference to a statutory provision shall be deemed to include reference to any statutory modification or re-enactment of it. 

Health and Safety Inspectors (including Explosives Inspectors) are appointed by the HSE to ensure compliance with the relevant statutory provisions. The inspectors have very wide ranging powers, and this is another factor that contributes to fireworks safety. 

In accordance with the statutory provisions, cellular products must be in compliance with CFR part 312 regardless of whether the finished product is shipped across state lines this is due to the use of ancillary products used in manufacture. Ancillary products (e.g., bioreactors and cell culturing systems components of culture media agents used to purge, select, or stimulate specific cell populations) are not intended to be present in final products, but they may... 

The statutory provisions have failed to end the controversy over risk assessment. From the outset some environmental groups have argued that the risk assessment, cost-effectiveness provisions of the NCP are meant to apply only to government-financed clean-up under Section 104 and do not apply to private clean-up under Section 106 or to voluntary private clean-up (4 ). Instead, they advocated that private clean-up be handled on a separate track oriented towards Justice Department enforcement of complaints which would be based on a zero-exposure, zero-risk theory. 

Of course these tables should not be used as legal advice. For more specific information it will be necessary to check the latest statutory provisions, patent office policies and probably even judicial decisions... 

The FDA implements the statutory provisions of the FFDCA and PHS Act and associated laws through regulations. Regulations are rules that generally have the force of law. They provide more explicit information about how a business or manufacturer should conduct their operations and submit information to... 

Product liability law, generally and as it pertains to pharmaceutical companies, is broadly based on legal principles involving contract law, the law of torts and the relevant statutory provisions of the country or jurisdiction where the action is brought (Jones, 1993). However, there are three fundamental legal principles under which a seller of a product can be liable for damages incurred from the use of that product strict liability, warranty and negligence. 

The defenses available to manufacturers in product liability actions vary, based on the respective common law or statutory provisions of jurisdiction in which the action is filed. However, certain legal principles commonly constitute a full or partial defense to product liability actions. 

Concurrent with enactment of these statutory provisions, the English judiciary was evolving a parallel body of both civil and criminal common law. Causes of action were recognized against those who sold adulterated food and those who maintained any common nuisance.(5)... 

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