Medical Devices

30
Jul
stack of one hundred dollars notes

FDA Announces MDUFA and Outsourcing User Fee Rates for FY 2020 – All Fees Higher

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 […]

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14
Jun

FDA Webinar on Medical Device Q-Submissions; They Require Both Precision and Timing

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: […]

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24
Apr

FDA Announces Enforcement Discretion for Postmarketing Safety Reporting of Combination Products

  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 […]

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13
Feb

SaMD (Software as a Medical Device), Medical Device Design Control and the Need for US Guidance

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 […]

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22
Jan

FDA User Fee Carryover Funds Dwindle as the Agency Tries to Keep the Boat Afloat

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 […]

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18
Dec

Ricki Chase Publishes Article in MedTech Insight

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 […]

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