Enforcement & Litigation
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News We're Watching: LDT Survey Finds Concern, Abbott Recall, New Q-Sub Guidance
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in schools; the former CEO of device company Stimwave was convicted on two counts of fraud; and the FDA issued a draft guidance document on the thermal affects of medical devices.
Biden Administration Requests $7.13Bn FDA Budget For FY2025, Includes $3.3Bn In User Fees
The White House’s 1,298-page budget request published on 11 March includes around $2m more than the total for FY24, which Congress approved on 8 March and the president signed the next day. Of the FDA’s total FY2025 spending, $3.286bn would come from user fees.
News We’re Watching: First OTC Blood Glucose Monitor, Recalls For Ventec and Medtronic, Guidance Docs Under White House Review
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.
Want to Have It All? Work In Government, Attorney Says
Anne Walsh speaks to Medtech Insight about her practical advice for women in the legal field and why she volunteers to provide networking opportunities for female lawyers.
Doing More With … Well, About The Same. Congress Gives FDA Slight Bump In ‘24 Budget
A funding package of six budget bills required to avoid a government shutdown shows that Congress plans to allocate $6.72bn to the FDA for FY 2024, an increase of just over 2% above the agency’s 2023 budget. The increase, however, comes from user fees, not the agency’s budget authority, which lawmakers cut by $8m from last year.
News We’re Watching: New Cybersecurity Standard; CMS Prodded On TCET; Olympus Scopes Recalled
This week, NIST published a new version of its international cybersecurity standard; SeaStar Medical’s kidney device got an HDE; and the FDA announced safety issues for DT MedTech LLC, operating room tables, and GE incubators.
Warning Letters And Close-Outs – January/February 2024
The US Food and Drug Administration has released three warning letters and two close-outs so far this year, with missives citing problems with premarket authorizations, quality systems compliance and reporting.
DOJ: False Claims Settlements Neared $2.7Bn In 2023
The government collected $2.68bn from settled False Claims Act cases last year, the US Department of Justice said. Another 12 device-related cases were announced in February alone.
Da Vinci Surgical Robot Insulation Defects Led To Florida Woman’s Death, Lawsuit Alleges
Intuitive Surgical is facing claims that malfunctions of its da Vinci surgical robot led to a woman’s death following a laparoscopic surgery.
News We’re Watching: CDRH’s Maisel Announces Retirement, Fresenius Clearance, Philips and Smiths Recalls
This week, a device center stalwart prepared to say goodbye; the FDA cleared Fresenius's 5008X Hemodialysis System; and class I recalls for Smiths Medical and Philips Imaging were announced.
FOIA Claims Bring Electroshock Device Dispute Back To Courts
A year after Congress officially gave the FDA the power to ban devices for a specific use, the school that inspired the new law is taking the agency back to court on allegations it has failed to respond to document requests.
US FDA’s Needs To Fortify Supply Chain Among Legislative Priorities In 2025 Budget
As the FDA’s Office of Policy, Legislation and International Affairs finalizes the agency’s yearly budget, it already is looking ahead to next year.
$2Bn Hike In Catheter Billings Could Point To Fraud
The US government is said to be investigating a sudden spike in Medicare billings for urinary catheters, which jumped from $153m in 2021 to $2.1bn in 2023.
US FDA’s Congressional Education Becoming More Essential With Key Member Departures
Energy and Commerce Committee Chair Cathy McMorris Rodgers’ decision not to seek reelection may mean FDA officials must orient a new chair on their activities and priorities.
News We're Watching: AliveCor Suit Dismissed, IMDRF Comes To DC, Digital Health Caucus
This week, AliveCor's patent infringement lawsuit against Apple came to an end; industry stakeholders submitted comments to the FTC on the right to repair; Cardinal Health and Percussionaire announced recalls; and the IMDRF announced a March meeting in Washington, DC.
What Devices Are Essential During A National Emergency? FDA Panel Makes A List
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.
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