OBJECTIVE: Discuss the working ideas of the dynamic adjustment mechanism of medical device classification in the United States, and provide reference for the construction of medical device related mechanisms in China. METHODS: Collect and interpret the documents of regulatory background, procedures and orders of the dynamic adjustment mechanism of the medical device classification in the United States, and summarize the overall situation and specific cases of the medical device classification adjustment under this mechanism in recent years. RESULTS: The US work idea of the medical device classification dynamic adjustment mechanism is based on the latest valid scientific evidence, conducting risk analysis and identification, and determining the corresponding measures. CONCLUSIONS During the adjustment process, industry stakeholders have repeatedly discussed and achieved final agreement. Its procedures and working ideas can be used as a reference for China's work.
China ; United States ; United States Food and Drug Administration

This study introduces the establishment and the situation before and after the reorganization of Center for Devices and Radiological Health (CDRH). Meanwhile, it sorted out the important changes in this reorganization of CDRH. CDRH optimizes regulatory decisions by integrating pre-marketing and post-marketing professionals for the total product lifecycle of medical devices, based on product line guidelines. Taking the sutatus of Chinese medical device supervision into consideration, this study put forward some thoughts on scientific supervision.
Device Approval ; Marketing ; United States ; United States Food and Drug Administration

A recent meta-analysis of clinical trials found that long-acting beta2-agonists (LABA) increased life-threatening asthma exacerbations and deaths, which led to warnings concerning regular use of LABA by U.S. Food and Drug Administration (FDA). It is now obvious that LABA monotherapy in asthma increases the risk of serious adverse events. However, the risk is reduced with concomitant use of inhaled corticosteroid (ICS). Hence the FDA's recommendations that LABA should not be used in patients whose asthma is well controlled with a medium dose of ICS, or LABA should be withdrawn once asthma control is achieved, remain still controversial. It seems reasonable to follow current guidelines which recommend the use of LABA when asthma is not controlled with ICS, although more well-designed research on the safety of LABA, especially when combined with ICS, is required.
Asthma ; Humans ; United States Food and Drug Administration

On the basis of introducing FDA's regulatory measure and relevant requirement for life-cycle management of combination product, this paper aims to discuss corresponding countermeasure for supervision system construction in consideration of domestic drug-device combination product's current situation, in order to promote innovative development of relevant industries.
Device Approval ; Drug Approval ; United States ; United States Food and Drug Administration

PURPOSE: To evaluate the actual state of quality control in Korea through an analysis of mammographic phantom images obtained from a multicenter, and to determine the proper exposure conditions required in order to obtain satisfactory phantom images. MATERIALS AND METHODS: Between April and June, 2002, 193 phantom images were referred to the Korea Food and Drug Administration for evaluation. Two radiologists recorded the number of fibers, specks and masses they contained, and the "pass" criteria were as follows: checked number of fibers: four or more; specks, three or more; masses, three or more (a total of ten or more features). Images in which optical density was over 1.2 were classified as satisfactory. In addition, changes in the success ratio, and difference between the two groups (i.e. "pass" and "fail", with regard to exposure conditions and optical density) were evaluated. RESULTS: Among the 193 images, 116 (60.1%) passed and 77 (39.9%) failed. Among those which passed, 73 /100 (73%) involved the use of a grid, 80/117 (68.3%) were obtained within the optimal kVp range, 50/111 (45.0%) involved the use of optimal mAs, and 79/112 (70.5%) were obtained within the optimal range of optical density. Among those which failed, the corresponding figures were 17/52 (32.6%), 33/66 (50.0%), 31/69 (44.9%), and 35/65 (53.8%). There were statistically significant differences between the pass and fail rates, and with regard to kVp, optical density, and the use of a grid, but with regard to mAs, statistical differences were not significant. If only phantom images with an optical density of over 1.2 [as per the rule of the Mammographic Quality Standard Act (MQSA)] was included, the success rate would fall from 60.1% to 43.0%. CONCLUSION: The pass rate for mammographic phantom images was 60.1%. If such images are to be satisfactory, they should be obtained within the optimal range of optical density, using optimal kVp and a grid.
Korea ; Quality Control ; United States Food and Drug Administration

A novel synthetic hexapeptide (SFKLRY-NH2) that displays angiogenic activity has been identified by positional scanning of a synthetic peptide combinatorial library (PS-SPCL). This study was carried out to investigate the irritation of the SFKLRY-NH2 on the skin. The tests were performed on the basis of Korea Food and Drug Administration (KFDA) guidelines. In results, cell toxicity is not appeared for SFKLRY-NH2 in HaCaT cells and B16F10 cells. SFKLRY-NH2 induced no skin irritation at low concentration (10 microM), mild irritation at high concentration (10mM). We consider that this result is helpful for saying about the safety of SFKLRY-NH2 in clinical use.
Korea ; Oligopeptides ; Peptide Library ; Skin ; United States Food and Drug Administration

This paper introduces the risk classification and listing way of medical devices in the United States, and according to the contents in various situations, FDA provides the requirements for clinical evaluation. At the same time, through the comparative study on the similarities and differences between USA and our country of the clinical evaluation, the paper puts forward some suggestions.
Equipment and Supplies ; standards ; Risk Assessment ; United States ; United States Food and Drug Administration

The study of peptide drugs has been an important direction in research and development of new drugs. However, lots of natural macromolecular peptides are limited in clinical use by their metabolic instability and low bioavailability. In recent years, the active small peptidomimetics open up a new hotspot of peptide drug development with the characteristics of low molecular weight, high bioactivity and structural modification. Many peptidomimetics are on the market or on the clinical study. This paper elaborated the small peptidomimetics approved by American Food and Drug Administration (FDA) from 2005 to 2014, and reviewed their researching status with source, synthetic method, chemical structure, marketing time, indication, clinical efficacy and safety. Research prospects in this field were discussed.
Biomedical Research ; trends ; Peptidomimetics ; United States ; United States Food and Drug Administration

OBJECTIVESTo analyze medical device recall information of FDA U.S. and to address the safety issue of medical device.

METHODFor each report, the recall class, product name, product class and recall reason were recorded and classified for analysis.

RESULTS3093 reports were identified; the recalling reasons of the three classes were significantly different. It is found that the main recall reason for medical material is package problems (39%) and design defectiveness (19%), for medical tools are design defectiveness (27%) and package problems (26%), and for medical equipment are design defectiveness (45%) and system failures (39%). The number of software recalled is 109. The main recall reason for high risk equipment is design defectiveness, and the I class level of high risk equipment recalled was decline in 2006 compared to that in 2005.

CONCLUSIONMonitoring and application of medical device recall information should be strengthened, and the objective law of medical device safety issue should be summed up, in order to provide reference for supervision of medical device.

This article summarizes the progress and specifications of FDA regarding intravascular catheters, and hope this would be helpful to people concerned.
Catheterization, Central Venous ; standards ; Catheters, Indwelling ; standards ; United States ; United States Food and Drug Administration