By Seeram Ramakrishna, Lingling Tian, Charlene Wang, Susan Liao, Wee Eong Teo
Medical units and rules: criteria and Practices will make clear the significance of rules and criteria between all stakeholders, bioengineering designers, biomaterial scientists and researchers to permit improvement of destiny scientific devices.
Based at the authors’ functional adventure, this booklet offers a concise, useful consultant on key matters and procedures in constructing new clinical units to satisfy overseas regulatory requisites and criteria.
- Provides readers with a world point of view on clinical equipment regulations
- Concise and finished info on easy methods to layout scientific units to make sure they meet laws and standards
- Includes an invaluable case examine demonstrating the layout and approval process
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Extra info for Medical devices : regulations, standards and practices
A 510(k) is a premarket submission to FDA to demonstrate that the device to be marketed is at least safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA . PMA is a FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device [23, 26].
If available, data for an equivalent device already on the market may be submitted. Manufacturers of these devices select NB to evaluate their devices and receive a CE mark. The CE marking symbolizes the conformity of the product with the applicable European Community requirements imposed on the manufacturer. The CE markings are affixed to products that conform to all applicable European Community provisions and indicate that the appropriate conformity assessment procedures have been completed.
To determine if a device requires a 510(k), a check with the FDA will be required. gov/Medi calDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051530. htm) and identify your device and the corresponding regulation. (12) What are the Class I devices that are exempted from the GMP requirements with the exception of complaint files and general record keeping requirements? Refer to the US Food and Drug Administration. (2014). Class I/II Exemptions. htm. (13) How is the public’s health safeguarded after a device is on the market?