NEEDLE-BEARING DEVICE PERFORMANCE STANDARD DEVELOPMENT BY FDA
This article was originally published in The Gray Sheet
Executive SummaryNEEDLE-BEARING DEVICE PERFORMANCE STANDARD DEVELOPMENT BY FDA would be mandated under legislation introduced March 10 by Rep. Pete Stark (D-Calif.). The bill (H.R. 1304) states that not later than one year after enactment, FDA "shall prescribe safety performance standards for syringes" and "such components of intravenous systems as" FDA "deems appropriate" for "purposes of preventing accidental needlestick injuries to health care providers." The agency also would be required to "consult with appropriate private sector experts" in developing or revising the standard, which would be reassessed annually by the agency. The bill, which is similar to legislation introduced by Stark in February 1992, lends support to one portion of a petition pending at FDA. The petition, submitted by the Service Employees International Union in April 1991, asks the agency to develop a performance standard for needle-bearing devices, reclassify the devices into Class III and deem all needlestick injuries reportable events under medical device reporting regulations ("The Gray Sheet" April 27, 1992, I&W-8). The Stark bill also would temporarily impose a 10 cents excise tax on the "taxable sale" of syringes and intravenous items that do not meet the performance standard. The tax would go into effect on Jan. 1, 1997 and would be terminated three years later. Stark is proposing the needle tax to "ensure a mass-market for safe needles and provide the necessary production economies of scale to ensure low prices," a press release on the bill notes. The tax would not be imposed until 1997 "to give manufacturers, marketers and health care facilities ample time to develop the most reliable, low-cost, mass-produced safe needles possible." The bill defines taxable sale as "any sale of a taxable medical item to a health care provider for use in the United States in providing health care services, but only if such sale is the first sale to such a provider for such use after manufacture, production, or importation."
You may also be interested in...
Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.
US FDA’s ‘Project Renewal’ requires lots of work and flexibility, Oncology Center of Excellence acknowledges. Side-benefit may be getting outside physicians to appreciate the value of drug labeling.
The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.