The Food and Drug Administration (FDA) is classifying the B-type natriuretic peptide (BNP) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled "Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry ...

Over the last several years, the United States Food and Drug Administration (FDA) has significantly improved the time required for the approval of PMA and PMA supplement applications. By the year 1999, the average approval time for PMA applications was 12 months and the average approval time for PMA supplements ...

Contingent physical guidance was used to treat chronic aerophagia. This consisted of guiding the participant's hand over her mouth following each attempt to engage in aerophagia. A wristwatch was then correlated with the contingent physical guidance procedure. Responding remained low in the presence of the wristwatch, even after contingent physical ...

The Food and Drug Administration (FDA) is amending the biologics regulations applicable to microbiological controls for licensed Anti-Human Globulin (AHG) and Blood Grouping Reagents (BGR). FDA is amending the regulations to remove the requirements that the products be sterile. FDA is publishing this direct final rule because the requirement that ...

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for barium enema retention catheters and tips with or without a bag with certain limitations. This rule will exempt from premarket notification barium enema retention catheters and tips with or ...

The Food and Drug Administration (FDA) is classifying the Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled "Guidance for Industry and FDA Reviewers: Class II Special Control Guidance Document for Anti-Saccharomyces ...

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for the triiodothyronine test system with certain limitations. This rule will exempt from premarket notification the triiodothyronine test system intended for measuring the hormone triiodothyronine in serum and plasma. FDA ...

The Food and Drug Administration (FDA) is issuing a final rule that amends its menstrual tampon labeling regulation to add the term "ultra" absorbency for tampons that absorb 15 to 18 grams (g) of fluid with the syngyna test. At present, FDA requires standardized terms to be used for the ...

Non-US manufacturers marketing in vitro diagnostic (IVD) products in the United States (US) or planning to do so should be aware of a US Food and Drug Administration (FDA) manufacturing guideline. Although it needs to be updated to include design controls and a few other requirements in the current Quality ...

The Food and Drug Administration (FDA) is issuing a final rule to reclassify from class III to class II the extracorporeal shock wave lithotripter, when intended for use to fragment kidney and ureteral calculi. FDA is taking this action on its own initiative in order to assure that these devices ...

The author analyses certain aspects of the narration of a generally taciturn hysterico-phobic obsessional patient as they appear in the transference relationship, pinpointing its phallic mastery and the sadistic impact of the domination over the audience/analyst that underlies this mode of discourse. She examines them in relation to Proust's 'A ...

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for a Group 1 preamendments class III device, the obstetric data analyzer intended to analyze data from fetal and ...

In June 1999, the Food and Drug Administration issued draft guidance for bioequivalence studies for nasal aerosols and nasal sprays for local action. The purpose of this opinion paper is to highlight the need for a balanced scientific debate before this guidance is used by underscoring the areas in the ...

Although insect herbivory is frequently assumed to be responsible for the maintenance of plant secondary metabolites such as alkaloids, the assumption is controversial and experimental evidence for this assumption is sparse. We examined natural selection on the two major alkaloids present in the leaves of Datura stramonium and found that ...

BACKGROUND AND PURPOSE: The treatment of cystine stones is a clinical problem. This in vitro study was performed to establish an experimental system that enables standardized and reproducible investigations on chemolysis of cystine stones to look for an improvement of dissolution strategies. MATERIALS AND METHODS: Artificial spherical stones made of ...

Although the regulations of the Americans with Disabilities Act (ADA) of 1990 were phased in by 1992, monitoring and enforcement continue to be problematic. This study of three large shopping centers in the Southwest included one mall that was opened in the mid-1990s, and two malls that were constructed prior ...

The electronic mood device (EMD) is designed to help answer questions about the variability and dynamics of emotions. It is a small, portable instrument used for repeated recording of moods and feelings. Both construction and operation of the EMD are described. The EMD can best be conceived of as an ...

The Food and Drug Administration (FDA) is issuing a final rule to retain three class III preamendment devices in class III and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following devices: The lung water ...

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the penile inflatable implant, a generic type of medical device intended for the treatment of erectile dysfunction. ...

The Food and Drug Administration (FDA) is reclassifying from class I into class II the cardiopulmonary bypass accessory equipment device that involves an electrical connection to the patient, the goniometer device, and the electrode cable. FDA is also exempting these devices from the premarket notification requirements. FDA is reclassifying these ...

The Food and Drug Administration (FDA) is classifying the nonimplanted, peripheral electrical continence device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and ...

The Food and Drug Administration (FDA) is classifying the laser fluorescence caries detection device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and ...

Chemical sterilants are used to high-level disinfect semicritical medical devices such as flexible endoscopes. For the chemosterilant to obtain a high level disinfection claim, The Food and Drug Administration requires demonstration of a 6-log reduction of myobacterial inoculum under worst case conditions (2% horse serum added to test sterilant). This ...

Special and Abbreviated 510(k)s are two new approaches to obtaining clearance for medical devices to be marketed in the United States (US) that are designed to streamline the traditional 510(k) review process. This article answers commonly asked questions relating to the requirements for these types of 510(k)s, preparation of applications, ...

The Food and Drug Administration (FDA) is classifying the biotinidase test system into class II (special controls). The special control that will apply to this device is restriction to sale, distribution, and use as a prescription device. The agency is taking this action in response to a petition submitted under ...

The Food and Drug Administration (FDA) is publishing an order granting in part a petition requesting exemption from the premarket notification requirements for vascular tunnelers with certain limitations. This rule will exempt from premarket notification stainless steel vascular tunnelers of single unit construction. FDA is publishing this order in accordance ...

The Food and Drug Administration (FDA) is classifying the nitric oxide administration apparatus, nitric oxide analyzer, and nitrogen dioxide analyzer into class II (special controls). The special control that will apply to these devices is a guidance document. The agency is taking this action in response to a petition submitted ...

A total of 104 couples participated in a randomized crossover trial to compare a new baggy condom with a straight-shaft condom produced by the same manufacturer. Participants completed a coital log after using each condom. All couples used five condoms of each type. Among 102 couples who did not report ...

The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to Intelligent Surgical Lasers, Inc. (ISL), (now doing business as Escalon Medical Corporation), reclassifying the Neodymium:Yttrium:Aluminum:Garnet (Nd:YAG) Laser for use in peripheral iridotomy from class III to class II (special ...

sigmaS (RpoS) is the master regulator of the general stress response in Escherichia coli. Several stresses increase cellular sigmaS levels by inhibiting proteolysis of sigmaS, which under non-stress conditions is a highly unstable protein. For this ClpXP-dependent degradation, the response regulator RssB acts as a recognition factor, with RssB affinity ...

The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors and health care (user) facilities of adverse events related to medical devices. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food ...

The Food and Drug Administration (FDA) is amending certain references in various medical device regulations. The amendments update the references in those regulations to various standards of the American Society for Testing and Materials (ASTM) to reflect the current standards designations. Elsewhere in this issue of the Federal Register, FDA ...

The Food and Drug Administration (FDA) is classifying the nonresorbable gauze/sponge for external use, the hydrophilic wound dressing, the occlusive wound dressing, and the hydrogel wound dressing into class I (general controls). FDA is also exempting these devices from premarket notification procedures. This action is being taken under the Federal ...

The United States Food and Drug Administration (FDA) has issued a draft guidance document on the type of quality system information to be included in various premarket submissions. This is the same information that should be maintained at the manufacturing facility for devices subject to the premarket notification or 510(k) ...

The Food and Drug Administration (FDA) is classifying the electrogastrography system (EGG) into class II (special controls). The special controls that will apply to the EGG system are restriction to prescription use, certain labeling requirements, design requirements, and data collection requirements. The agency is taking this action in response to ...

The Food and Drug Administration (FDA) is publishing a guidance entitled "Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides guidance on ...

The Food and Drug Administration (FDA) is announcing changes to its Orphan Products Development (OPD) grant program for fiscal year (FY) 2000. The previous announcement of this program, which was published in the Federal Register of August 5, 1998 (63 FR 41855), is superseded by this announcement. In the future, ...

The Food and Drug Administration (FDA) is revoking an advisory opinion entitled "FD&C Act Trade Correspondence, TC-61," (hereinafter called TC-61) dated February 15, 1940, because it is out of date with current scientific knowledge and is superseded by the final rule for over-the-counter (OTC) sunscreen drug products. As an advisory ...

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during July, August, and September 1998, relating to the Medicare and Medicaid programs. This notice also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that ...

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Immunotoxicity Testing Guidance." This guidance is intended to provide FDA reviewers and manufacturers with a coherent strategy for assessing whether testing for potential adverse effects involving medical devices or constituent materials and the immune system is ...

The Food and Drug Administration (FDA) is publishing a list of documents issued in response to the Food and Drug Administration Modernization Act of 1997 (FDAMA), and clarifying their applicability to medical devices regulated by the Center for Biologics Evaluation and Research (CBER). This notice is intended to inform the ...

This regulation establishes a time-limited tolerance for combined residues of avermectin in or on avocado. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of the pesticide on avocado. This regulation establishes a maximum ...

The Food and Drug Administration (FDA) is announcing the availability of a compliance policy guide (CPG) entitled "Foods--Adulteration Involving Hard or Sharp Foreign Objects." This CPG is intended to help FDA components and industry comply with FDA's internal enforcement process concerning foods that contain hard or sharp foreign objects.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #1." The final regulations implementing the Mammography Quality Standards Act of 1992 (the MQSA) will become effective April 28, 1999, and will replace the interim regulations ...

The Food and Drug Administration (FDA) is classifying the nasal dilator, intranasal splint, and the bone particle collector into class I (general controls). FDA is also exempting the devices from the requirements of premarket notification. This action is taken under the Federal Food, Drug, and Cosmetic Act (the act), as ...

The conduct of a clinical investigation of a medical device to determine the safety and effectiveness of the device is covered by the investigational device exemptions (IDE) regulation. The purpose of IDE regulation is "to encourage, to the extent consistent with the protection of public health and safety and with ...

We describe a physical mechanism for creating multisoliton bound states by which optical solitons are glued together by attraction between the nonsoliton beams that they guide, solitonic gluons. We verify the concept of the solitonic gluons experimentally, observing a suppression of the repulsion between dark solitons owing to an attractive ...

Regulatory issues in graft development range from mundane to complex because of the extensive diversity in graft technology. This article, describes the regulatory differentiation between types of grafts, incorporating a description of the system for classifying devices by the Food and Drug Administration (FDA). Information relating to the need for ...

The conduct of a clinical investigation of a medical device to determine the safety and effectiveness of the device is covered by the investigational device exemptions (IDE) regulation. The purpose of IDE regulation is "to encourage, to the extent consistent with the protection of public health and safety and with ...

Since 1993, consistent with its statutory responsibility to ensure that regulated products are safe, pure, and free of << extraneous organisms, >> the United States Food and Drug Administration (FDA) has requested that, with certain exceptions, bovine-derived materials from animals born in or residing in countries where bovine spongiform encephalopathy ...