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

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

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that LABA should not be used in patients whose asthma is well controlled with a medium dose of ICS, or LABA should be withdrawn once asthma control is achieved, remain still controversial.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

Combination products face unique R&D, manufacturing, clinical, and regulatory challenges compared to individual devices, drugs, or biological products. Based on the interpretation of the relevant policies and the latest principles of combination products, this paper expounds the FDA's guidance, application trends, and application strategies for the pre-market pathways of combination products, with a view to providing relevant information for Chinese researchers and manufacturers when they start to entry the United States market.
Commerce ; Consumer Product Safety ; Direct-to-Consumer Advertising ; United States ; United States Food and Drug Administration

As a special kind of in vitro diagnostic devices（IVDs）, laboratory developed tests（LDTs） are of great significance to the development of clinical laboratories. This study aims to explore the regulatory requirements ideas of LDTs. By introducing the development of LDTs and the changing of regulatory requirements in the United States, combing the current regulatory framework and discussing relevant ideas in the regulatory requirements of LDTs.
Clinical Laboratory Services ; Laboratories ; Reagent Kits, Diagnostic ; United States ; United States Food and Drug Administration

Registration and approval is a necessary step in product marketing process of new medical devices to ensure their safety and efficiency.At present,many countries are relatively strict in the management of high risk medical devices,especially for class Ⅲ medical devices.Taking clinical trials as examples,they cost too many human,material resources.FDA has introduced a variety of regulations and policies to streamline the registration process to speed up the product marketing process.Based on the introduction of the relevant regulations on the exemption in parts of medical device registration and approval process in the United States,this paper compares and analyzes the simplified status of medical device approval in China.In the end,the significance of exemption in the registration and approval process is expounded,and some suggestions on how to optimize and approve the registration and approval process of medical devices in China are put forward.
China ; Device Approval ; Humans ; Registries ; United States ; United States Food and Drug Administration

A detailed analysis on re-classification procedure of medical devices from Food and Drug Administration.The experience on classification procedures,the work-flow of risk reanalysis and regulatory categories reassessment of listed products,as well as launching a comprehensive evaluation and downgrading of listed high-risk products were explored in recent years.Based on the analysis on classification procedures and supervision of medical device products in the USA,and combined with the current situation of classification of medical devices in China,some suggestions were put forward on the current classification mode of medical devices so as to improve the quality and efficiency of classified management of medical devices in China.
China ; Equipment Safety ; Equipment and Supplies ; United States ; United States Food and Drug Administration