USA -
FDA Backs Off From Regulating Certain Types of Health Software

The US Food and Drug Administration (FDA) on Thursday unveiled three guidance documents – two draft and one final – that clarify which types of software will be regulated.

One of the draft guidances, the 13-page “Clinical and Patient Decision Support Software,” outlines which types of clinical decision support software (CDS), which can compare patient-specific signs with available clinical guidelines to recommend treatments, would no longer be defined as a medical device, and thus would not be regulated.

“For example, generally, CDS that allows for the provider to independently review the basis for the recommendations are excluded from the FDA’s regulation,” FDA Commissioner Scott Gottlieb, who testified before the Senate Committee on Health, Education, Labor & Pensions on Wednesday, said in a statement...

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USA -
AdvaMed Raises Questions With FDA’s Combo Product Proposed Rule

AdvaMed is taking issue with the US Food and Drug Administration’s product jurisdiction proposed rule, which the device group thinks strays from how the 21st Century Cures Act defined combination products, according to comments released Monday. Some of the proposed revisions run counter to the plain language and intent of Section 3038 of the Cures Act , AdvaMed said. The group is seeking to clarify that a combination product’s primary mode of action shall not be determined to be that of a drug or biologic solely because the product features “any chemical action” in or on the body. “Given the...

Study -
Stimulation of Brain’s Reward System Leads to Reduction in Cancer Tumors

Scientists at Technion – Israel Institute of Technology have come up with a surprising way of fighting tumors and in the process showed that our brains have a role in preventing the growth of cancers. The researchers, who reported their findings in journal Nature Communications , artificially stimulated the reward system of mice stricken with cancer. What the investigators showed is that over time, the mice that received stimulation had significantly smaller tumors than control mice that were not administered the therapy. The team believes that their stimulation affected the nervous system so...

UK -
Register as a manufacturer to sell medical devices

Register a manufacturer or authorised representative (agent) for a manufacturer, to sell medical devices, including in vitro diagnostic (IVD) medical devices. Overview If you place certain medical devices on the EU market you or your designated authorised representative must register with the competent authority (national health regulator) in the EU state where you have an office or place of business. In the UK, Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority for the registration of medical devices. MHRA will only register manufacturers or authorised...

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