English masters, please. Translation urgently needed!

Due to the strong penalty for negligence in order to be able to register a medical device manufacturer to sell the device connected to the network software of no manufacturer can assume that there is no requirement for them to be filed as a device manufacturer. If in doubt, the Food and Drug Administration should be consulted. In the very small, competent advice to expertise on software that is regulated at the FDA should consult with the FDA to determine the status of all specific software products prior to accepting the software. [6] Hospitals and other users of medical equipment face sturdy responsibility for defective equipment. [12] Negligent substantiation of the device's Food and Drug Administration registration may be subject to authority to damage penalties. The Food and Drug Administration is understandable and reponding to software vendors for failure to registerunder action. Negligent registration may result in civil and criminal penalties. Further, the new structure of the action and the new approach to enforcement may result in targeting unregistered manufacturers. In particular, Operation 1990 gave the FDA many tools to penalize unregistered manufacturers.

Paragraph 2: The 1976 medical device corrections outlined for most products are relatively simple. Device manufacturers must register as a medical device manufacturer and file required year-end reports. Manufacturers must file a premarket notification with the Food and Drug Administration before placing the device on the market. Manufacturers must follow the appropriate bylaws for "required" good manufacturing practices.

Paragraph 3: What is most striking about the1990 action is the change in management philosophy. Under the1976 action, devices were put into three categories, based on risk, with the charter increasing as the purse strings tightened, from general controls (Category I), to performance standards (Category II), to premarket identity (Category III). However, the FDA found the regulations difficult to use because the performance standards were too difficult to establish and the premarket approvals were too expensive. To cope with the loading, the FDA adapted the smaller part of the action, 510(k) practice, to authorize 95% of all medical devices. This portion of the action was designed as a transitional component and was "greatly enhanced" by the "equivalent" of "device management" to the first 1976 devices that were grandfathered. 510 (k) process fundamentally intervenes in a premarket notification to manufacturers of their products. intent of the FDA to sell the product. To be processed through this manufacturers must claim that there is nothing novel about their products, and that everything in the product is simply an ie that existed prior to 1976 to rectify the device.

Paragraph 4: The 1990 action changes in accordance with the FDA's practice of treating FDA 510 (k) s. The statule expressly approves the FDA methodology, but with enhanced reporting and reporting of the FDA's practices. The FDA methodology is explicitly approved by the statule, but with enhanced reporting and enforcement mechanisms. Changes to the software network were particularly important in 1976 from, so a few of them existed to claim that arguably it is difficult for them to be vastly equivalent to the former calibration device.