Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls have been set back 50 years as the oceans continue to rise,
In two separate Federal Register notices (here for medical devices and here for outsourcing facilities), the FDA announced the user fee amounts for FY 2020. The FDA notes that the fees are effective on October 1, 2019 (the beginning of the 2020 FY) through September 30, 2020.
The medical device fees are provided in the charts below,
On June 11, 2019, the FDA held a CDRH webinar on the Q-Submission Program for Medical Device Submissions. The webinar was based on the recent May 7, 2019 Final Guidance document titled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” This guidance document supersedes “Requests for Feedback on Medical Device Submissions: Pre-Submission Program and Meetings with FDA and Staff.”
In an immediately effective guidance document entitled Compliance Policy for Combination Product Postmarketing Safety Reporting (here), the FDA is announcing that it will exercise enforcement discretion for certain safety reporting requirements outlined in the Combination Product Postmarketing Safety Reporting Final Rule issued on December 20, 2016 (81 FR 92603) and codified in 21 CFR Part 4,
In my own humble opinion, Scott Gottlieb’s resignation will come as a blow to both the industry and the public health of our nation. Dr. Gottlieb will stay in his position for about a month. There is no speculation as to whom his replacement will be, and, while some of the news outlets cite his taxing weekly commute to Bethesda/D.C.
I am currently attending the SDMD (Software Design for Medical Devices) Global IQPC conference in Berlin, where I presented on “Harmonization of Agile Methodology and Medical Device Design Control”. This topic was chosen because, currently, there is no FDA Guidance on this issue, and to provide insight to developers to implement these systems using a lean,
It will only be weeks until the User Fee carryover money for all the User Fee programs runs out. While Commissioner Gottlieb is doing his best to shuffle resources, the Agency will likely be up the perpetual tributary without any physical means of propulsion soon.
Because the Agency cannot accept any new fee-paying applications since the shutdown started,
Ricki Chase, Director, Compliance Practice, authored an article published in Medtech Insight, “How Device Makers Can Leverage FDA Data to Uncover The Agency’s Current Thinking on Compliance”. In this article, she discusses how manufacturers can use information available online from inspectional observations, warning letters, and product recalls to ascertain FDA’s priorities with regards to compliance and enforcement actions.