Geography

The US FDA’s Patient Engagement Advisory Committee met Wednesday to discuss ways the agency can empower patients thinking about whether to participate in clinical trials of regulated medical products. Central to the committee’s discussion was not only the type of information patients need to evaluate when considering joining a study, but how that information should be presented to them.

Recognizing October as cybersecurity awareness month, the US FDA has added new publications to its list of resources concerning the cybersecurity of medical devices.

This week, Medtronic and Hologic announced major safety issues; the US government awarded $110m to innovators in women’s health; CDC partnered with Quest on a bird flu diagnostic; and more.

When former FDAer Steve Silverman last wrote for us, there was no formal successor to Jeff Shuren as director of CDRH. With the elevation of acting director Michelle Tarver, the future is becoming more clear.

El Salvador has approved a new law that will establish a new regulatory body responsible for authorizing medicines and setting prices.

This week, Quidel recalled the Triage cardiac panel due to a risk of false results; Teladoc and Lifebit announced new partnerships; and, a court upheld a false advertising verdict against Natera, but struck the financial penalties.

This week, North Carolina health secretary Mandy Cohen was named the new head of the CDC; Congress debated PAHPA reauthorization; Cala Health launched a Parkinson’s Disease wearable; and IHealth.io was fined for consumer privacy violations.

The US FDA says it’s “investigating certain imported medical gloves that appear to have been reprocessed, cleaned, or recycled and sold as new.” The 270 firms in question are listed on an import alert that says their gloves are subject to Detention without Physical Examination.

The Life Sciences Innovative Manufacturing Fund, set out in the UK budget last month, is live for applications. More UK medtechs would benefit if the cost threshold were scaled down, the industry argues.

The European Commission has issued a draft document setting out the potential conditions for joint HTA scientific consultations on medical devices taking place in parallel with consultations with an expert panel.

Device supply interruptions and withdrawals, now common in the EU, could threaten patient safety. Newly issued manufacturer guidance from the European Commission is intended to improve transparency and minimize disruption.

UK chancellor of the exchequer Rachel Reeves said her 2024 budget announcement would address the problem of ‘hospitals being without the equipment they need.’

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

After high-level deliberations, a draft Medical Device Administration Law to supersede the series of medical devices administrative orders has been issued by the Chinese State Food and Drug Administration. A stakeholder consultation is underway.

The Australian teletrials program has surpassed expectations at its mid-way point and is being used by drug and device sponsors looking to enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.

European cross-country HTA collaborations have much to learn from each other to keep prices from rising unfairly, Nordic health technology assessment experts say, adding that talks on collaboration are also ongoing with HTA bodies outside the continent.

This week, Hologic announced it would pay $350m for uterine fibroid treatment firm Gynesonics; the US FDA authorized a Novocure cancer treatment and a surgical robot from CMR Surgical; and the IMDRF announced 15 new members.

The medical device industry supports the FDA's draft guidance document on Diversity Action Plans but seeks flexibility and clarity, especially for international and IVD trials, and recommends using real-world data for postmarket studies.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.