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IRC2008年11月26日讯： FDA将在2008年12月19日颁布新的医用检查手套和手术手套的法规21 CFR 800.20, 并对2006年12月19日颁布的两年过渡期的最终导则提出调整，主要调整是FDA的测试和评估进口产品的抽样方案AQL将更加严格：

调整后的AQL抽样方案为：

Patient Examination Gloves医用检查手套从过去的 4.0 调整到 2.5

Surgeon's Gloves from 手术手套从归去的2.5 调整到 1.5

FDA计划从2009年1月1日起对进口美国的上述产品按照新抽样方案执行海关检查。预计将有大量进口产品被列入质量未达标产品，所以在此提示所有中国出口美国上述产品的制造商和贸易商，请您务必提早准备，避免不必要的损失。

附：FDA通告

Dear U.S. FDA Registered Glove Manufacturers:

The Division of Small Manufacturers, International and Consumer Assistance (DSMICA)  wants to make you aware that on December 19, 2008  the new rule (21 CFR 800.20) regarding FDA sample plans and test methods for Patient Examination Gloves and Surgeon's Gloves will take effect.  The most significant change in this rule is that the Acceptable Quality Levels (AQL) that FDA uses to evaluate medical gloves marketed in the United States will change from 4.0 to 2.5 for Patient Examination Gloves and from 2.5 to 1.5 for Surgeon's Gloves.  FDA published the final rule in the Federal Register on December 19, 2006 with a two-year interval prior to the effective date.

We expect that FDA will start to test and evaluate shipments of gloves introduced into commerce in the United States using the new AQLs in January 2009.   We also expect that since the AQLs are now more restrictive, this could result in more glove shipments being declared adulterated.  Before submitting further medical glove shipments for entry, you should take appropriate steps to assure that your manufacturing and quality practices are adequate to produce gloves that are consistently below the new AQLs.

Attached is a scanned copy of the new version of 21 Code of Federal Regulations (CFR) Part 800.20 (800-1299) that becomes effective December 19, 2008.  Also included, for comparison, are the AQL tables with adulteration levels that are effective until December 19, 2008.  Comparing the tables will enable you to evaluate what changes, if any, may be needed to bring your gloves into conformance with the new AQLs.

If you have any questions, please contact DSMICA by:

·         Email at dsmica@fda.hhs.gov

·         Phone at 800-638-2041 or 240-276-3150

·         Fax at 240-276-3151

A prerequisite to compliance with any rule or regulation is an understanding of that rule.  The aim of our office is to assist you to lawfully market safe and effective medical devices.  Please do not hesitate to contact us for any regulatory help you may need.  We look forward to assistance you.

Sincerely yours,

John F. Stigi

Director

Division of Small Manufacturers, International and Consumer Assistance

U.S. Food and Drug Administration

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