Regulations & Standards
    For the manufacturers and users of in vitro diagnostics, 1998 is likely to go down as a watershed year. That's because this is the year that the Health Care Financing Administration (HCFA) will begin to carry out the mandates of the Balanced Budget Act of 1997 (BBA), which seem destined to have wide-ranging and long-lasting effects on clinical laboratory products and practices. The BBA requires HCFA to convene a negotiated rule-making committee for the purpose of developing...
    The revolution now under way in the field of IVDs is bringing about rapid change in both the technologies used in diagnostic tests and the methods used for assessing their performance. Manufacturers have responded to the needs of physicians and other health-care providers by developing new generations of rapid, accurate, and simple-to-use diagnostics that can deliver results at the point of care. Even more impressive are the revolutionary technologies that are still on the...
    Over the past decade, the regulation of research use only (RUO) and investigational use only (IUO) products has been one of the most contentious compliance issues in the IVD arena. FDA has been trying to develop a policy for the regulation of RUO and IUO products for many years. This January, the agency took another step toward finalizing its regulatory approach by releasing its latest draft of an enforcement policy. The new document is a compliance policy guide (CPG) entitled...
    Two years ago, FDA identified analyte specific reagents (ASRs) as its highest regulatory priority in the field of IVDs. Now the agency has issued its final rule on the subject. Published in the Federal Register on November 21, 1997, the rule will become effective on November 23, 1998.1 It has been several years since FDA first asserted its authority to regulate so-called "home-brew" assays directly through the premarket approval (510(k)) process. While the agency has...
    With a single letter, FDA substantially changed the regulatory environment for blood establishments and their vendors of blood-bank software. Issued in 1994 by the agency's Center for Biologics Evaluation and Research (CBER), the letter states: Facilities that manufacture and distribute these [blood-bank] software products are subject to the device provisions of the Federal Food, Drug, and Cosmetic Act [FD&C Act] and FDA's device regulations, including establishment...
    Inspectional inconsistency is an issue that has had a profoundly negative impact on both individual manufacturers and the medical device industry as a whole. In order to better understand this problem, the Baltimore IVD Roundtable last year created a working group on inspectional consistency, giving it the tasks of identifying instances of inconsistency, describing the causes that led to them, and recommending corrective actions (see box, page 52). The working group's inquiries...
    The winds of change are blowing throughout FDA, but nowhere so favorably as in the agency's Center for Devices and Radiological Health (CDRH). After several years of suffering caused by an extensive backlog of product submissions, the device center is making strong efforts to get out from under its ever-increasing mountain of paperwork, including product applications, correspondence, and medical device reports. A key factor in the center's progress toward this goal has been its...
  FDA has often dismissed allegations of inspectional inconsistency as more perception than reality. Now, IVD companies are coming forward with examples to prove that such charges are more than just a figment of industry's imagination. In recent years, members of the medical device industry--including IVD companies--have frequently alleged that FDA is very inconsistent in its inspections of manufacturers. Such allegations are commonly supported by accounts of individual inspections, and...
      For more than 10 years, FDA and industry have struggled over issues related to commercialization of reagents labeled "For investigational use only" or "For research use only." Scientific advances, particularly in the area of genetic testing, threaten to generate a flood of new reagents, exacerbating this already difficult situation. This article discusses the current situation and summarizes a newly conceived policy proposal. ore than 1000 individual IVD...