The role of Food and Drug Administration regulation of in vitro diagnostic devices--applications to genetics testing.

The Food and Drug Administration (FDA) has been involved in the regulation of in vitro diagnostic devices (IVDs or laboratory tests) since the introduction of the Medical Device Amendments of 1976. IVDs developed as kits or systems intended for use in multiple laboratories require review by the FDA before being marketed to ensure appropriate performance and labeling. IVDs developed as in-house, or so-called "home-brew", tests or laboratory test services are considered medical devices, but historically have not been subject to premarket review as a matter of enforcement discretion. FDA recently established a new regulatory paradigm for in-house tests based on classification of the active ingredients or building blocks of these tests as analyte-specific reagents (ASRs). ASRs are exempt from premarket review but subject to both manufacturing and labeling controls. Currently, genetic tests are received and reviewed by the FDA in the same manner as other in vitro diagnostic tests. The FDA currently is in the process of chartering a new genetics advisory panel to provide the agency with outside expertise to deal with genetic testing issues. We are also continuing to work with other agencies within the Department of Health and Human Services to determine how we can cooperatively help foster this important new area of testing.

Alleviating gender role strain in adult men with traumatic brain injury: an evaluation of a set of guidelines for occupational therapy.

OBJECTIVE: A set of guidelines to assist men with traumatic brain injury (TBI) to alleviate gender role strain was assessed to determine its effectiveness and acceptability to participants. METHOD: Four adult male participants with TBI received the intervention (the set of guidelines) for 4 months. The intervention consisted of rebuilding self-identified gendered social roles and activities. Focused interviews and participant observation were used to determine whether gender role strain changed after intervention. RESULTS: The participants reported that the intervention enabled them to (a) enhance their gender role satisfaction through newly rebuilt roles and activities, (b) attain certain long-held personal goals, (c) feel more like members of society, (d) perceive a greater congruency between their internal self-images and external postinjury roles, (e) learn more about personal skills and values as men, (f) feel more comfortable using help-seeking behaviors, (g) feel a sense of shared experience and affinity, (h) feel more understood and accepted, and (i) contribute to others through community member roles. DISCUSSION: The set of guidelines for alleviating gender role strain was effective in assisting these participants to enhance their gender role satisfaction through rebuilding desired male-gendered social roles and activities. Dating, courtship, extended family member, community member, friend, and mentor-protege roles, lost as a result of TBI, were rebuilt through gender-neutral activities that facilitated a sense of volitional control, competency, and normalcy. Nonetheless, the men continued to lack desired rites of passage leading from male adolescence to adulthood.

Student level II fieldwork failure: strategies for intervention.

OBJECTIVE: This report describes how common student communicative and behavioral characteristics that appear to predict the existence of potential problems during Level II fieldwork were identified in order to develop and implement preventative interventions during the academic curriculum at New York University (NYU). RECORD REVIEW: A record review of NYU professional-level occupational therapy students from 1986 to 1995 was completed to identify common factors among students who performed well academically but failed clinical fieldwork. Eight communicative and behavioral characteristics were identified: (a) rigidity of thinking, (b) discomfort with the ambiguity that accompanies clinical reasoning, (c) lack of psychological insight, (d) difficulty interpreting feedback, (e) externalization of responsibility, (f) difficulty learning from mistakes, (g) discomfort with the physical handling of patients, and (h) dependence on external measures for self-esteem. INTERVENTION: On the basis of the identified characteristics, five intervention strategies were adopted: (a) academic seminars that address professional behavior and interpersonal skills, (b) faculty feedback to students regarding problematic behaviors, (c) clinician and senior student counseling with identified students, (d) student remediation programs consisting of community service, and (e) student learning contracts based on specific behavioral objectives. These strategies were administered before Level II fieldwork to 10 students in the 1996 class who exhibited the characteristics indicative of potential fieldwork failure. OUTCOME: Of the 10 students in the 1996 class, 7 passed fieldwork without further difficulty, two failed fieldwork midterm assessments but went on to achieve passing final evaluations, and one failed the final fieldwork assessment but passed an additional third fieldwork experience. The class of 1996, which was the first to receive formal intervention designed to decrease fieldwork failure, demonstrated lower fieldwork failure rates than did all other classes in the past 10 years.

Occupational therapy's link to vocational reeducation, 1910-1925.

The development of occupational therapy is rooted in early 20th century medical reform. During the early 1910s, several members of the medical profession, human service workers, and the larger American society were increasingly disturbed by medical practices that did not consider the individual's personal experience of disability. Occupational therapy was developed, in part, out of this desire to provide persons with treatment that helped them to function in their communities despite their disability. Early occupational therapy leaders envisioned the fledgling profession as a societal service capable of assisting persons with disabilities to return to both work and community life. Vocational reeducation was initially considered to be an integral component of occupational therapy in the years from 1910 to 1920. However, the profession's early link to vocational reduction was challenged by vocational technical trainers during World War I. To prevent occupational therapy from being subsumed by vocational technical training, the early occupational therapy leaders implemented several strategies: adoption of physician prescription for all occupational therapy services, delivery of occupational therapy services primarily within hospital settings, and dissociation from vocational reeducation services. Reasons accounting for why the early occupational therapy leaders abandoned their initial commitment to vocational reeducation are explored. Suggestions about how this decision has affected present-day practice are also offered.

Regulatory issues unique to clinical trials on periodontal diagnostic methods and devices.

A wide variety of in vitro diagnostic products have been proposed for use in patients with periodontal disease. The Food and Drug Administration (FDA) review focuses on three important issues. First, the product must exhibit acceptable analytical performance (accuracy, precision, analytical sensitivity, and analytical specificity). Second, the effectiveness of the device must be clearly defined. The studies required to establish this will depend largely on the proposed intended use of the product. At a minimum, clinical or diagnostic sensitivity and specificity should be established. Finally, the product must meet the labeling requirements for in vitro devices. These requirements outlined in CFR 809.10(b) are comprehensive and cover 15 key elements including information about the principles of the analytical method; handling of instruments, reagents, and patient samples; test limitations; and test performance. Applicants developing products for any in vitro diagnostic device are encouraged to review the labeling regulations along with other divisional and office guidance material to help in defining the submission requirements. The FDA is willing to meet and work with companies prior to and during preclinical and clinical trials to assist in the development of appropriate study protocols.

[Biomechanical and neurophysiological characteristics of voluntary rhythmic movements in humans]. / Biomekhanicheskaia i neirofiziologicheskaia kharakteristika proizvol'nykh ritmicheskikh dvizhenii cheloveka.

Amplitude modulation of electroencephalogram and H-reflex were studied under realization and completion of voluntary rhythmic movements and its modelling by means by electrical stimulation of the triceps sure muscles in humans. The changes of spinal cord alpha-motoneurons excitability was correlated with the cycle duration under rhythmic voluntary movements realization and not depend on cycle duration under its semantic completion. The alpha-motoneurons excitability was stable and did not determine by model movement frequency in condition of rhythmic electrical stimulation and after its stopping. Analysis amplitude modulation of electroencephalogram and H-reflex under voluntary rhythmic movements showed correlation between cortical and spinal processes under its organization.

The experience of head injury on the impairment of gender identity and gender role.

OBJECTIVES: This study explored the disruption of gender identity and gender role as a result a traumatic brain injury (TBI). METHOD: Four adults (two men, two women) who sustained a TBI between the ages of 18 and 30 years and were at least 1 year postinjury participated in six 1-hr interviews concerning changes in (a) perceived masculinity or femininity, (b) involvement in intimate relationships, (c) enactment of gender roles, and (d) organization of activities that support gender roles. RESULTS: The men expressed greater feelings of gender inadequacy postinjury than did the women and appeared to have greater difficulty resolving rites of passage (e.g., achievement of the adult work role, marriage, parenting) and developmental issues characteristic of the life stage at which they experienced their injury. The men appeared to depend more heavily on traditional gender-specific activities before and after injury to define and support gender role; the women relied more on cross-gender activities. The women appeared to be able to maintain more preinjury activities postinjury than did the men. CONCLUSION: Postinjury possession of a personally satisfying sense of gender appears to be related to the ability to maintain much of the preinjury activities that defined and supported the participants' sense of masculinity or femininity. The ability to satisfactorily resolve rites of passage or developmental issues characteristic of the life stage at which the brain injury occurred appears to be related to the ability to participate in activities that define and express gender role during that particular life stage.

Food and Drug Administration (FDA)'s impact on laboratory performance: FDA's perspective.

The Division of Clinical Laboratory Devices is responsible for the premarket review of in vitro diagnostic devices (laboratory tests). We currently process >1000 diverse applications per year. New versions of old devices are handled as premarket notifications, so-called 510(k) submissions. The review objective is to establish that the new product is "substantially equivalent" to its predicate. Fundamentally new devices are handled as premarket applications. The review objective is to establish de novo that the product is ¿safe and effective.¿ A central regulatory issue over the past several years has been the development of a standardized model for scientific review. The Food and Drug Administration contributes to the quality of in vitro diagnostic devices by providing oversight and objective review, by setting thresholds for product safety and effectiveness, and by ensuring that organized data and appropriate labeling is present in support of a device's intended use.