Medical Devices

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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