Guidance

The US FDA has published draft guidance for developers of drug delivery devices listing recommendations related to device design outputs essential for establishing and assessing the performance of their products.

In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.

A new FDA lab-developed test compliance guide for small enterprises summarizes agency policy but fails to address clinical lab industry concerns about the LDT final rule.

New draft guidance on clinical trial diversity action plans pushes for disproportionately high enrollment of traditionally underrepresented groups, while also asking companies to tailor global programs to US populations and consider diversity aspects that Congress did not outline. 

The US FDA has issued its final guidance defining manufacturer behaviors it deems as hampering the agency’s ability to conduct an inspection. In a previous draft guidance, the agency expanded its longstanding policy on inspections of drug companies to include device makers as well.

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

Device attorney Jason Brooke says that the FDA’s recent guidance document on device remanufacturing represents a “missed opportunity” to discuss software.

Stakeholders say the US FDA’s Q-sub guidance could use some tweaking, especially for identifying when informal meetings with the agency are more appropriate than formal ones and creating less burdensome timelines.

The CNIL plans to update its data protection methodologies based mostly on the results of a new consultation and the outcome of a pilot in which companies are asked to identify the challenges they have faced when designing trials with decentralized elements.

Will it be necessary to provide a new medical device notified body opinion when changes are being made to the medicine in an integral drug-device combination product? This is just one of the new topics addressed in an updated Q&A document from the European Medicines Agency.

After clarifying what a remanufactured device is in its 2021 draft guidance, FDA’s final guidance adds information about regulatory requirements for companies whose devices qualify as remanufactured.

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

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.