Product registration, premarket

FIFRA23 imposes a system of pesticide product registrations. Such requirements include premarket review of potential health and environmental effects before a pesticide can be introduced in the United States, reregistration of products introduced prior to the enactment of FIFRA to assess their safety in light of current standards, and classification of pesticides for restricted or general use. Restricted products can be used only by those whose competence has been certified by a state program. 

The new fee structure, which sees premarket evaluation fees gradually reducing and post-market annual product registration charges increasing, is being phased in over 5 years. At the end of the transition period, revenue from pre-market evaluations will be 60% rather than 80% under the previous arrangements. The revised structure will make TGA s revenue less vulnerable to fluctuations in number of major applications. 

There are five fundamental elements of FDA regulation of medical devices (1) facility registration and product listing (2) safe use of investigational devices (3) premarket notification (unless exempt) and product labeling ... 

The investigator is generally not permitted to include any observations on the FDA-483 relating to labels, promotional materials, product classifications (new drug application [NDA], premarket application [PMA], etc.), or registration requirements. It is not inappropriate to ask why such observations are included on an FDA-483. It could be an error that could result in either removal of the observation or clarification that headquarters has approved its inclusion. 

Premarketing control of locally manufactured, imported, exported and sold pharmaceutical products. This part deals mainly with the issuance of ministerial notifications, setting up quality and standards, technical review, inspection and testing before approval and granting of licenses for pharmaceutical entrepreneurs and registration certificates of pharmaceutical products. 

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