medical devices

The FDA opens the books on how its accredited third-party reviewers are performing under the 510(k) pathway, revealing review times that stretch well beyond agency averages in some cases. The data offers device makers a rare look at where third-party review speeds up, and where it stalls, market access.

The EU Commission adds several product categories to its list of exemptions from consumer battery replaceability rules, citing safety and technical complexity. Learn which devices are affected and what the exemption could mean for manufacturers navigating the EU's evolving battery regulations.

The FDA has finalized its guidance on human factors information required in medical device marketing submissions, outlining a risk-based framework for 510(k)s, PMAs, De Novo requests, and HDE applications. Here's what manufacturers need to know before their next premarket submission.

The FDA has updated its list of more than 1,700 recognized voluntary consensus standards used to demonstrate compliance in medical device premarket submissions. Find out which specialties are covered and how declarations of conformity can streamline your path to market authorization.

The FDA is inviting medical device developers to participate in the READI-Home Innovation Challenge, seeking proposed solutions for home-use medical technologies that reduce hospital readmissions, with selected participants receiving direct regulatory feedback to refine their designs.

The FDA has finalized guidance on premarket submission requirements for weight loss medical devices, covering non-clinical testing, clinical study design, and benefit-risk analysis. Developers of intragastric implants, aspiration therapy systems, and neuromodulators will want to review the agency's recommendations closely.

As hospitals fill with wireless devices—from patient monitors to smartphones—radio frequency interference threatens medical device performance and patient safety. This article explores the critical testing methodologies, regulatory requirements, and risk management strategies manufacturers need to ensure their wireless medical devices work reliably in today's crowded spectrum environments.

FDA device clearance times remain lengthy—averaging 140–175 days, far beyond the 90-day goal. Staffing cuts and process shifts fuel delays, while underused third-party review programs offer a potential shortcut for manufacturers seeking faster approvals.

The U.S. Food and Drug Administration (FDA) has recently updated its list of medical devices that have received market authorization under its Breakthrough Devices Program.

The U.S. Food and Drug Administration (FDA) has released data that it says affirms the safety of certain per- and polyfluoroalkyl substances (PFAS) used in medical devices.