Guidance

An updated guide from the Therapeutic Goods Administration proposes that sponsors of marketing applications for drugs that require companion diagnostics should provide reassurance that Australian patients will have access to at least one IVD that is adequate for companion testing.

Senator Bill Cassidy says FDA “disregarded” Congressional intent by expanding its authority to regulate clinical decision support software.

The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.

The Therapeutic Goods Administration says it has made a series of improvements in areas such as the recall and stakeholder communication process, reporting requirements, and the agency’s guidance materials.

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

Want to know if a much-needed official EU medtech regulatory document is in the pipeline? An updated list of guidance and other documents in the making is now available.

This week, the US Congress advanced legislation that would support better cardiac emergency preparedness in schools; the former CEO of device company Stimwave was convicted on two counts of fraud; and the FDA issued a draft guidance document on the thermal affects of medical devices.

Draft guidance from the US Food and Drug Administration details what the agency wants to see to demonstrate cybersecurity in connected devices during premarket submissions. 

Discussions during the second day of the 25^th session of the International Medical Device Regulators Forum focused on the establishment of working groups to iron out a plethora of issues for international harmonization.

This week, the US FDA announced that it had cleared Dexcom’s Stelo Glucose Biosensor System, making it the first OTC device of its type available in the US. Additionally, the Office of Management and Budget took up guidance documents on cybersecurity and enforcement on diagnostics during emergencies, and recalls were announced by Medtronic, Ventec and Cardinal.

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

The document waives the annual registration fee for companies with gross sales below $1m that are currently going through bankruptcy.

In a recent guidance document, the FDA explains how trial sponsors should collect and present data on the race and ethnicity of trial participants.

Members of the US FDA’s General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee met on 6 February to discuss what medical devices are critical to public health during a national emergency and help the FDA create a list of those devices.

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.

The second meeting in a series of town halls by the FDA announced the creation of a Tiger Team dedicated to medical device sterilization innovation.