Category Archive: Medical Devices

/ Medical Devices

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

By | June 14, 2019 | FDA, Medical Devices, Regulatory Affairs | Like |

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.”

So,

FDA Announces Enforcement Discretion for Postmarketing Safety Reporting of Combination Products

By | April 24, 2019 | ANDAs, BLA, Combination Products, FDA, Medical Devices, PMA, Regulatory Affairs | Like |

 

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,

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Commissioner Gottlieb Resigns – A Blow to the FDA and the Health of the Nation

By | March 5, 2019 | Compliance, FDA, Generics, Medical Devices, New Drugs | 10 |

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.

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

By | February 13, 2019 | FDA, Medical Devices, Regulatory Affairs | 5 |

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,

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

By | January 22, 2019 | ANDAs, FDA, Generics, Medical Devices, Regulatory Affairs | Like |

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 Publishes Article in MedTech Insight

By | December 18, 2018 | Combination Products, Compliance, FDA, Manufacturing, Medical Devices | Like |

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.