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Results for “Reclassification”

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At least 379 records · Page 21Linked to original sources
PubMed1993

Medical devices; reclassification and codification of microsurgical argon laser for rhinology and laryngology--FDA. Final rule.

The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to HGM Medical Laser Systems, Inc., reclassifying the microsurgical argon laser for use in rhinology and laryngology from class III (premarket approval) to class II (special controls). The order is being codified in the Code of Federal Regulations as specified herein.

Argon↗
PubMed1993

Independent contractors or employees? Reducing reclassification risks.

With the aggressive stance taken by the IRS regarding worker classification, many organizations may be risking significant retroactive assessments with respect to the use of independent contractors. Employers should be aware of the 20 primary factors considered by the IRS when examining independent contractor relationships and prepare in advance for IRS classification review or audit.

Contract Services↗
PubMed1998

Hematology and pathology devices; reclassification; restricted devices; OTC test sample collection systems for drugs of abuse testing--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to reclassify over-the-counter (OTC) test sample collection systems for drugs of abuse testing from class III (premarket approval) into class I (general controls), and to exempt them from the premarket notification (510(k)) and current good manufacturing practice (CGMP) requirements. FDA is also proposing to designate OTC test sample collection systems for drugs of abuse testing as restricted devices under the Federal Food, Drug, and Cosmetic Act (the act), and to establish restrictions intended to assure consumers that: The underlying laboratory test(s) are accurate and reliable; the laboratory performing the test(s) has adequate expertise and competency; and the product has adequate labeling and methods of communicating test results to consumers. Finally, FDA is proposing a conforming amendment to the existing classification regulation for specimen transport and storage containers, to clarify that it does not apply to specimen transport and storage containers that are part of an OTC test sample collection system for the purpose of testing for the presence of drugs of abuse or their metabolites in a laboratory.

Consumer Product Safety↗
PubMed1998

Orthopedic devices: classification and reclassification of pedicle screw spinal systems--FDA. Final rule.

The Food and Drug Administration (FDA) is classifying certain previously unclassified preamendments pedicle screw spinal systems into class II (special controls) and reclassifying certain postamendments pedicle screw spinal systems from class III (premarket approval) to class II. FDA is taking this action because it believes that special controls would provide reasonable assurance of safety and effectiveness. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Device Approval↗
PubMed1998

Medical devices; reclassification and codification of vitamin D test system--FDA. Final rule.

The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to INCSTAR Corp. reclassifying INCSTAR 25-Hydroxyvitamin D 125I Radioimmunoassay (RIA). This radioimmunoassay device is intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency. The device and substantially equivalent devices of this generic type were reclassified from class III (premarket approval) to class II (special controls). Accordingly, the order is being codified in the Code of Federal Regulations.

Device Approval↗