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CDRH is now issuing electronic export documents for medical devices instead of paper to improve efficiency, reduce the amount of time it takes for a manufacturer to receive export documents, and decrease environmental burden. Read More
In its continuing effort to step up post-pandemic enforcement activities, the FDA wrapped up 2023 by making public three Form 483s for as many Indian pharmaceutical manufacturers. Read More
The FDA is increasingly finding cybersecurity lapses during inspections of medical device manufacturing facilities — and most often because cybersecurity risk management is not fully documented as part of design controls, according to compliance expert Eric Henry. Read More
The FDA is seeking input from a wide variety of stakeholders on a draft report on best practices for streamlining the development, dissemination and use of guidances. Read More
To regulate new medical device technologies, the FDA should rely on familiar regulatory processes to review low-risk activities while adopting a more attentive approach that devotes greater resources to high-risk activities, according to a former agency commissioner. Read More
The FDA is seeking input on a new draft guidance intended to help manufacturers develop strategies for ensuring potency in human cellular or gene therapies (CGT). Read More
BioTelemetry, owned by Philips, and its subsidiary LifeWatch Services have agreed to pay more than $14.7 million to resolve allegations that they violated the False Claims Act by knowingly submitting claims to federal government programs for a higher level of cardiac monitoring than physicians intended to order. Read More
Over the past week, the FDA issued a final rule on direct-to-consumer prescription drug advertisements. The agency issued final guidance on development of drugs and biological products for rare diseases, direct-to-consumer promotional labeling and advertisements and, reformulating drug products that contain carbomers manufactured with benzene. Draft guidance was issued on potency assurance for cellular and gene therapy products and quality considerations for topical ophthalmic drugs. Read More
The FDA will kick off the new year under another possible threat of a shutdown because lawmakers have so far failed to agree on fiscal 2024 funding for the federal government and stopgap funding is set to expire on Jan. 19 — just over one week after the House and Senate begin the new session. Read More
Acclarent, a division of Johnson & Johnson, has received FDA clearance for use of its AERA eustachian tube balloon dilation system in the treatment of children age 8-17 with persistent obstructive eustachian tube dysfunction (OETD), the first such treatment available for children. Read More
A five-year-old agreement between the FDA and the Cybersecurity and Infrastructure Security Agency (CISA) on medical device cybersecurity should be updated to reflect new practices, according to a recent report by the U.S. Government Accountability Office (GAO). Read More