United States
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development
Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering independent valuation of models should be available by year-end as part of FDA’s involvement with Coalition for Health AI.
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in schools; the former CEO of device company Stimwave was convicted on two counts of fraud; and the FDA issued a draft guidance document on the thermal affects of medical devices.
EPA Final Rule Limits Use Of Ethylene Oxide
The rule, which requires most device sterilization plants to track and report their EtO emissions, will go into effect in two years for the smallest plants and three years for the largest.
As A Young Woman Marissa Fayer ‘Fell’ Into Medtech. Now, As An Industry Leader, She’s Focused On Leveling The Field
Marissa Fayer is dedicated to advancing women’s health. The founder and CEO of HERhealthEQ, a global nonprofit focused on women’s health equity in emerging and developing countries, Fayer is also the CEO of DeepLook Medical. As part of our focus on women’s health in honor of Women’s History Month, Fayer spoke to Medtech Insight about the importance of having more women in all sectors of medtech, both for the benefit of industry as well as women patients.
Cybersecurity Guidance Update Lays Out ‘Cyber Device’ Rules
Draft guidance from the US Food and Drug Administration details what the agency wants to see to demonstrate cybersecurity in connected devices during premarket submissions.
Day 2: IMDRF Guidance Documents In The Works
Discussions during the second day of the 25th session of the International Medical Device Regulators Forum focused on the establishment of working groups to iron out a plethora of issues for international harmonization.
Global Regulators Home In On Regulatory Reliance, Propose Universal Framework
Regulatory reliance was the theme on Day one of the 25th Management Committee of the International Medical Device Regulators Forum in DC, with regulators from across the globe touching on the need for clarity, consistency, and trust among the world’s various regulatory bodies. The attendance for this year’s meeting was largest in the history, with some 1,200 guests representing more than 60 countries and 550 public and private sector organizations.
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.
FDA Looking To Streamline Sterilization Submissions Through Bundling, PCCPs
The FDA’s fourth town hall on sterilization reviewed the agency’s Master File Pilot Programs, the use of PCCPs for sterilization changes and the process for bundling multiple sterilization change 510(k)s.
Lilly Pre-Approval Spadework Includes Alzheimer’s Blood Test Development, Unbranded DTC Ads
Lilly is supporting development of blood-based tools for early diagnose of Alzheimer's, but the delay of the review for donanemab will create more distance from Lilly’s direct-to-consumer advertising spotlighting its commitment to Alzheimer’s research.
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.
‘Borrowing Confidence’ And Other Mentorship Lessons From FDA DHCOE Deputy Director
Sonja Fulmer tells Medtech Insight about her unconventional career path and how she uses her senior role to inspire younger women in regulatory roles, just like her mentors did for her.
Medtech Connect Episode 13: Augmented Reality In Surgery
In this episode, US regulatory reporter Hannah Daniel speaks to Ocutrx CEO Michael Freeman about augmented reality in medical products and their not-so-unique regulatory requirements.
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.
FDA Set To Drop Final Rule On LDTs, Sends Draft To White House
The US FDA has delivered a draft of its final rule on regulating lab-developed tests to the Office of Management and Budget, signaling it could meet the White House’s expectation for publishing its final rule by April.
Global Medtech Guidance Tracker: February 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.