Device makers object to FDA’s proposed recall guidance; Medical device titan Boston Scientific and industry lobbying group AdvaMed respond to the FDA’s latest draft guidance on medtech recalls, warning that the new language may cause more confusion than it clears.
Heart device approval delays leave US doctors frustrated; Americans accustomed to immediate access to the newest technology may be shocked to find that is not the case when it comes to devices that treat ailing hearts. U.S. approval requirements for cardiac devices are much more stringent than in Europe, where there is no centralized decision-making body. But a growing number of U.S. heart doctors feel the regulations are so demanding that patients are being denied access to beneficial therapies.
An international study involving 255 physicians practicing in Vancouver, Montreal, Sacramento and Toulouse found that physicians are not given enough information about the adverse effects of drugs during presentations made by medical sales representatives from pharmaceutical companies. And yet, these same physicians are willing to prescribe at least some of the presented drugs.
On May 23, the U.S. Food and Drug Administration announced that it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals. This is the first HbA1c test that FDA has allowed to be marketed for this use. The HbA1c tests, or A1c tests, currently on the market are FDA-cleared for monitoring a patient’s blood glucose (sugar) control, but not for diagnosing diabetes. A1c tests measure the percentage of hemoglobin A1c that is bound to glucose, giving a patient’s average glucose level over a three-month period.
The FDA lowers the regulatory bar for ingestible event markers, downgrading them from Class II to Class III devices. Effective May 17, the FDA is down-classifying ingestible event markers from the more burdensome Class III into Class II (special controls).
The Food and Drug Administration is able to do its work in part because of a symbiotic relationship with the industries it regulates. But recently that relationship has been knocked off balance.
Across 66 Countries, Data Reveals Technology-Focused Healthcare Cost-Containment Policies are Misguided; A new study of medical device spending in 66 countries finds that medical devices are a smaller burden on health spending, and are more affordable relative to GDP in Canada compared to most other countries
Lori, Caleb Nolan would probably object to be called little. He’s an active 7-year-old who plays football, baseball, soccer and basketball. He also was born with a rare form of cystic fibrosis that requires him to undergo rigorous treatments and take 23 pills every day.
The US Food and Drug Administration (FDA) may still be in the midst of figuring out how to overhaul its medical device compliance approach in regards to quality, but a new report out from device consultancy Emergo Group shows that the agency is dramatically ramping up the number of quality-related deficiencies it cites in its inspection reports.