USA – FDA Proposes New Ban of Electrical Stimulation Devices for Self-Injurious or Aggressive...
Today, the U.S. Food and Drug Administration (FDA) is proposing a ban of electrical stimulation devices (ESDs) intended to reduce or stop self-injurious or...
France – Tests génétiques sur Internet : la CNIL appelle à la vigilance
Des données collectées particulièrement sensibles
Les sites web de vente à distance de tests génétiques proposent, en général, des offres relatives à la filiation ou...
Europe – Recent ECJ ruling could lead to standards development tumult
Earlier this month, the European Court of Justice (ECJ) ruled there is “an overriding public interest” for the European Commission (Commission) to disclose harmonized...
USA – FDA panel’s green light on glaucoma wearable device offers hope in sight
On 21 March, an advisory panel to the U.S. Food and Drug Administration gave its unanimous blessing to a piece of wearable technology that...
USA – FDA wants sponsors to test devices that may cause tissue temperature changes
The US Food and Drug Administration (FDA) wants medical device sponsors to test products that may cause changes in tissue temperatures, regardless of whether...
USA – FDA warns consumers against using plastic syringes made in China
It’s not unusual for the US Food and Drug Administration (FDA) to publish warning letters about manufacturers that fail to meet its regulatory requirements,...
Europe – Euro Roundup: European Commission proposes streamlining regulations to boost biomanufacturing
The European Commission is set to assess how to streamline regulatory pathways for the biotechnology and biomanufacturing sector as part of a broader push...
USA – EPA finalizes rule to reduce EtO emissions from sterilization facilities
After a year of back and forth with the medtech industry, the US Environmental Protection Agency (EPA) has finally published a much-anticipated rule that...
USA – FDA proposes updates to device cybersecurity guidance
The US Food and Drug Administration (FDA) has released a draft guidance that proposes updating the agency’s final guidance on cybersecurity of medical devices. The update...
Europe – MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for...
When a sponsor of a clinical investigation submits an application according to article 70(1) of the MDR, to the Member State(s) in which the...
