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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Europe -
Harmonizing ISO 11607 with the EU's Medical Device Regulations

Revision of EN ISO 11607, the guiding standard for medical device packaging, is progressing toward completion later this year. With many of the changes prompted by EU’s new Medical Device Regulations (MDRs), could harmonization with the EU’s new law be next? ISO Technical Committee 198 Working Group 7 met earlier this year in Copenhagen to resolve comments received after ISO 11607’s Draft International Standard (DIS) document was balloted last year. The next step will be to finalize a Final Draft Standard (FDIS) for ISO Central Secretariat to review and then send out to ISO members for final...

USA -
FDA clears first contact lens with light-adaptive technology

The U.S. Food and Drug Administration today cleared the first contact lens to incorporate an additive that automatically darkens the lens when exposed to bright light. The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology are soft contact lenses indicated for daily use to correct the vision of people with non-diseased eyes who are nearsighted (myopia) or farsighted (hyperopia). They can be used by people with certain degrees of astigmatism, an abnormal curvature of the eye. The National Eye Institute at the National Institutes of Health estimates that 42 percent of...

USA -
FDA Invokes Authority to Issue ‘Unique Type of Restriction’ on Essure Contraceptive Device

In a “unique type of restriction,” the US Food and Drug Administration (FDA) issued an order Monday to limit sales and distribution of Bayer’s permanent contraception device, Essure, over the numerous health risks that have been associated with its use. The decision is based on a “review of a growing body of evidence” that led FDA to conclude “previous efforts to alert women to the potential complication of Essure” have not been enough to ensure they receive “this important information,” FDA Commissioner Scott Gottlieb said in a statement. The birth control product, thus, “requires additional...

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