2017: Draft of the guide of FDA
On December 11, 2017 Management of the USA on health control of products and medicines (FDA) issued the new draft of the guide for assessment of medical devices and support systems of adoption of medical solutions (CDS) in response to changes in the corresponding regulations.
According to the amendments to the federal law adopted in December, 2017, some program functions were excluded from determination "medical devices" and consequently, are not subject to supervision from FDA any more. These changes are considered in the new draft of the guide.
The devices intended only for transfer, storage, conversion of a format or data mapping and results of physical examinations are not medical devices any more and should not conform to requirements of FDA. However programs which are analyzed or interpret medical data, remain under normative control from FDA. This amendment will probably not have great practical value as FDA in 2015 refused the strengthened control of similar devices.
The document of the regulator also contains updates concerning mobile medical applications. Now mobile applications which display the medical images taught directly from a transmission system and archiving of images get under selective application of the right, i.e. FDA at discretion decides when it resorts to adequate measures of coercion. All mobile applications which are not intended for the diagnostic analysis of images are not considered as medical devices now.
Amendments concerned also support systems of adoption of medical solutions. The programs used for purpose of visualization researches do not fall under determination of the medical device now and are not under control of FDA any more. However the programs intended for receiving, processing or the analysis of medical images / a signal from a diagnostic system, will still be considered as medical devices and should conform to requirements of FDA.[1]
Notes
| The site content is translated by machine translation software powered by PROMT. The machine-translated articles are not always perfect and may contain errors in vocabulary, syntax or grammar. Read original article If you find inaccuracies or errors in the results of machine translation, please write to editor@tadviser.ru. We will make every effort to correct them as soon as possible. |