PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Device Approval”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 289 records · Page 16Linked to original sources
PubMed2003

Miracles in the making.

Explore the source record for details and available documents.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed1998

Dental devices; effective date of requirement for premarket approval; temporomandibular joint prostheses--FDA. Final rule.

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 certain devices, namely, the total temporomandibular joint (TMJ) prosthesis, the glenoid fossa prosthesis, the mandibular condyle prosthesis (for permanent reconstruction), and the interarticular disc prosthesis. At a later date, FDA will propose reclassifying from class III into class II the generic type of temporary mandibular condyle prosthesis intended for temporary reconstruction following surgical ablation of malignant and benign tumors. This action establishing the effective date of the premarket approval requirement for certain devices is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the FDA Modernization Act of 1997 (FDAMA).

Device Approval↗
PubMed1993

"Female condom" approved.

The Food and Drug Administration approved the first so-called female condom on May 7. Despite limited data on the effectiveness of the Reality Vaginal Pouch in sexually transmitted diseases (STDs) and a relatively high pregnancy rate among users, the device was approved because it is the first barrier contraceptive for women that provides some protection against STDs. The label will be required to emphasize that for "highly effective protection" against STDs, including AIDS, latex condoms for men are the best choice. The panel must also compare the pregnancy rate for the female condom--approximately 26%/year--to rates for other barrier contraceptives, which are lower. For example, the pregnancy rate for male latex condoms is approximately 15%/year. The females condom consists of a lubricated polyurethane sheath with a flexible polyurethane ring on each end. One ring is inserted into the vagina much like a diaphragm; the other remains outside, partially covering the labia. In addition to the labeling restrictions, FDA is also requiring the manufacturer of the product, Wisconsin Pharmacal of Jackson, Wis., to take part in additional effectiveness studies for the product. FDA's decision to approve the female condom was based on a review of clinical data submitted by the manufacturer and the unanimous recommendation of the agency's Obstetrics and Gynecology Devices Advisory Panel at its meeting on December 10, 1992. Wisconsin Pharmacal studies 200 women who used the device for 6 months. The estimated pregnancy rate of 26%/year in the study is believed to have been due in part to improper use of the device by some of the subjects. (The expected rate of pregnancy among women not using any contraceptive method is 85%). Women who use the device correctly each time they have intercourse can expect a lower pregnancy rate.

Americas↗
PubMed1992

Lower extremity applications of functional neuromuscular stimulation.

Functional electrical stimulation (FES) applications in the lower extremity are common in research laboratories, but clinical applications are minimal. This review summarizes current knowledge with respect to clinical application. When electrical stimulation is used in clinical applications for functional movement such as standing and walking, it is typically applied in an open-loop manner; a predetermined stimulus pattern is delivered regardless of the consequences of the actual movement. Few clinical applications of FES involve closed-loop control because of the numerous difficulties involved in its application. As with any volitional muscle contraction, electrically stimulated muscle contractions will exhibit fatigue. Although the dynamics of fatigue may differ, electrically stimulated muscle contractions cannot be continuously sustained, and if the duty cycle is too severe, even alternating periods of rest and contraction cannot be sustained at a constant force level. The exact nature of fatigue is highly specific to the past history of the individual muscle and to the individual subject. Despite their intricate detail, quantitative modeling studies have not yet been applied extensively to clinical applications. Present implantable systems are not yet a viable option for clinical application. It is not clear whether more success with surface or percutaneous systems must first be achieved to justify implantation or whether greater improvements in implantable technology and surgical protocols are needed before implantable systems will become practical. It is clear that almost any reasonably designed stimulation protocol will increase muscle bulk. The existence of other therapeutic benefits and their cost/benefit ratios remain to be fully established. It is possible to stand through bilateral stimulation of the quadriceps. Using surface electrodes, this technique is achievable in any physical therapy clinic having minimal expertise in neuromuscular stimulation. FES-aided standing must be conducted as a research project with a protocol approved by the local institutional review board, as there are currently no FDA-approved stimulation devices for standing. Multichannel FES systems are not currently available for clinical application in the United States. This may change if the "Parastep" system receives FDA approval. Percutaneous and implanted systems are years away from commercialization and clinical availability. Hybrid systems, based primarily on the reciprocating gait orthosis (RGO), are presently the only clinically available form of walking that includes some form of FES assistance. The costs and benefits of adding FES to the RGO and the long-term user acceptance rate for these systems remain to be determined.

Cerebrovascular Disorders↗
PubMed2000

Digital mammography. Why hasn't it been approved for U.S. hospitals?

Mammography is the only major imaging technique still unavailable in the United States in digital form. This is because the Food and Drug Administration (FDA) has been unable to devise an effective method for manufacturers to demonstrate the safety and efficacy of digital mammography systems. As a result, the agency has been unable to approve any of those systems for marketing in the United States. In this Regulatory Update, we describe FDA's recent efforts to help manufacturers obtain approval and the reasons those efforts have so far proved ineffective.

Breast Neoplasms↗
PubMed2006

Progress versus precision: challenges in clinical trial design for left ventricular assist devices.

New left ventricular assist devices promise fewer adverse events but, currently, only minor improvements in survival. Small (survival) treatment effects, limited patient populations, and the increasing number of left ventricular assist devices in development challenge the efficient conduct of premarketing trials (especially in destination therapy) and, maybe more importantly, hamper innovation. Novel trial designs would facilitate this process. Among a range of trial designs, we opt for small randomized trials, which would preserve the advantages of randomization and also allow for a shorter enrollment period. We also advocate an evidence shift toward postmarketing studies, with the Interagency Registry of Mechanically Assisted Circulatory Support providing a robust infrastructure.

Biomarkers↗
PubMed2002

Middle ear implantable hearing devices.

For over two decades, corporate and academic researchers have worked to develop practical middle ear implantable hearing devices (MEIHDs). Now that two such devices are approved by the U.S. Food and Drug Administration for sale in the United States, and several more are in development, it is time for clinicians to consider these devices as more than a passing idea. With more than 1500 implants in place worldwide, clinical evidence that describes the value of these devices as tools for the rehabilitation of sensorineural hearing loss is plentiful. The purpose of this article is to provide an overview of MEIHDs and to provide the clinician with some background of MEIHD technologies to help in the analysis of these devices as they appear on the market.

Acoustic Stimulation↗
PubMed2005

Keynote review: Is declining innovation in the pharmaceutical industry a myth?

Increasing the rate of innovation is a requirement to achieve much-needed advances in patient care, as well as to secure the future of the pharmaceutical industry. Currently, there is a perception in the external environment that pharmaceutical R&D is no longer innovative, fails to bring new drugs to market or, at best, produces a rising number of 'me-too' drugs with no advantage over existing treatments. In addition, the cost to discover and develop new medicines (i.e. cost per launch) has risen dramatically in recent years. The quoted development cost per medicine is a reality, and is not disputed here. However, data are provided that demonstrate that with regard to innovation rates, the current perception is wrong - although there have been, and continue to be, fluctuations in drug launches, there has been a steady increase in the number of new chemical entities launched, both in absolute numbers of FDA-approved medicines and in the proportion of priority reviews.

Cost-Benefit Analysis↗
PubMedDate not supplied

An introduction to the Food and Drug Administration and how it evaluates new devices: establishing safety and efficacy.

Most physicians, and certainly the lay public, have only limited knowledge of the responsibilities and limits of the Food and Drug Administration (FDA) of the United States of America. Although laws as early as 1902 protected the public from unrestricted sale of unsafe drugs, it was not until 1976 that devices came under regulation. An obvious difference existed between regulatory control of drugs vs devices. The drug-based approach for evaluation was rejected in favor of a new system based on device class and its degrees of risk. The premarket notification process (510K), and the premarket approval application (PMAA) became the regulatory pathway for device approval. The investigational device exemption (IDE) became the mechanism for established safety and efficacy. Occasionally conflicts exist between industry and the FDA. Submission of poorly planned studies wastes FDA resources whereas prolonged approval times can be devastating to the small single product business that creates the majority of our new devices. A compromise is obviously necessary if we are to maintain our premier identity as a new device entrepreneurial center and avoid industry's migration to countries where the regulatory standards might be less rigid.

Equipment Design↗
PubMed2004

Outcome after implantation of a novel prosthetic anal sphincter in humans.

BACKGROUND: A novel prosthetic anal sphincter (PAS) has been developed that aims to occlude by flattening and angulating the bowel, reproducing the action of the puborectalis muscle. The safety of the PAS has been confirmed in biomechanical, in vitro and long-term animal survival studies. The Medical Devices Agency approved implantation in 12 patients. METHODS: The PAS was placed in the pelvis around the anorectal junction via a transabdominal approach in 12 patients with severe faecal incontinence. The device was activated 6 weeks after surgery. Fibreoptic examination of the mucosa below the device was undertaken at various intervals during review. RESULTS: At a median follow-up of 59 (range 30-72) months nine of the 12 patients had a functioning PAS. There were no device-related infective complications after the initial operation but one patient developed pseudomembranous colitis and had the device removed. The PAS was effective in restoring continence in ten of 11 patients. Median (range) Cleveland Clinic continence scores improved from 16 (7-20) before to 3 (0-7) after surgery. In two patients the PAS was eventually removed owing to infection after revisional surgery. There was no clinical or histological evidence of gastrointestinal mucosal ischaemia. CONCLUSION: The PAS was effective in restoring continence. There was no device-related infection after the initial operation, no device erosion and no clinical or histological evidence of gastrointestinal ischaemia.

Adult↗