5/1/2000
NAMSA Testing Services now offers one-cell and two-cell mouse embryo tests to support the label claims made by manufacturers of reagents, supplies, or medical devices used in conjunction with assisted reproductive techniques (ART) and related procedures. The Food and Drug Administration has confirmed that all devices being submitted for clearance with label claims for use in ART (such as in vitro fertilization) must use the mouse embryo assay for lot-to-lot release, reinforcing the value of NAMSA’s new test.
The possible toxicity of the ART-related reagents, supplies, and medical devices is an issue because the effects of device toxicity may range from embryotoxicity to malformed offspring. Devices labeled for ART use (catheters, culture dishes, needles, syringes, gloves, reagents, and culture media) come in contact with eggs, sperm, and embryos during routine procedures. These ART procedures include in vitro fertilization (IVF), artificial insemination, embryo transfer (ET), gamete intrafallopian tube transfer (GIFT), intracytoplasmic sperm injection (ICSI), and zygote intrafallopian tube transfer (ZIFT).
The FDA draft guidance related to NAMSA’s mouse embryo test, IVF-ART 510(k) Guidance Rev. 7-1-98 entitled “Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures,” is available at the FDA website (www.fda.gov/cdrh).
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NAMSA is a multinational company specializing in nonclinical testing to determine the safety and effectiveness of medical devices. With laboratories in Ohio, Georgia, California, France, and Taiwan, NAMSA offers materials characterization, biocompatibility, and microbial testing services. NAMSA also manufactures sterilization monitoring products (RSIâ Rapid Indicators, RSIâ Challenge Test Packs, chemical indicators, and SPORTROLâ biological indicators), in addition to SPORTROLâ growth promotion products, and H-BACâ thromboresistant coatings.
For further information about this press release, contact:
Deborah Gibbs
NAMSA Corporate Marketing
Phone (949) 951.3110 (ext. 204) - FAX (949) 454.3059
or dgibbs@namsa.com
