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Approvals for the diagnostic kits using hybridoma 
technology have been issued since May 1981. Many applications for 
the approval of monoclonal -based diagnostic kits have gone 
through the regulatory route known as the 510 (K) process. Most 
biotechnology firms developing hybridoma test kits hope to place 
them on the market by going through the 510 (I) process. 
However, Abbott Laboratories in North Chicago, Illinois, recently 
won clearance through, another FDA channel, premarket approval 
(PMA) . Abbott already had approval for two carcinoembryonic 
antigen (CEA) kits using conventional antibody technology. In 
July 1981, Abbott filed a supplemental PMA because it wanted to 
make the kits using monoclonal technology. Both kits were 
approved in March. Because the kits were classified as class III 
devices, the strictest of the classes in which FDA places medical 
devices, Abbott had to use the lengthier PMA regulatory channel. 
Abbott is the first company, then, to have gained approval on a 
class III device using monoclonals. 
2 . The Occupational Safety and Health Administration (OSHA) : 
OSHA has addressed potential hazards to workers related to 
commercial recombinant DNA applications. In 1980, OSHA 
communicated to the NIH RAC that OSHA planned to regulate rDNA 
operations under its current authority. Thus, OSHA retained the 
right to determine, in the course of an inspection, whether the 
workplace is in compliance with the NIH Guidelines. Ostensibly> 
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