Medical Devices Archives - Page 5 of 5 - Lachman Consultant Services, Inc.

Hope at This Time of Giving Thanks

By Bob Pollock Nov 26, 2019 505(b)(2) Abuse deterrent Accelerated Approval Advertising Analytical Methods ANDAs Approvals Bioanalytical Bioequivalence Biologics Biosimilars BLA Brand Name Drugs Bulk Drugs List CBER CDER Chemistry Clinical CMC Combination Products Complex Generics Compliance Compounders Compounding Controlled correspondence CVM Data Integrity DEA Device Dietary Supplements Drug Pricing Drug Shortages eCTD Emerging Technology Enforcement Exclusivity FDA FDA First Generics Foods GDUFA Fees Generics Guidance Homeopathic Drugs ICH Imports International Label Changes Labeling Laboratories Manufacturing Medical Devices NDA New Drugs OGD Opioids OTC Petitions PMA Post Approval projectsnowflake Receipts Regulatory Affairs Safety Science & Technology Shortages Training Uncategorized User Fees Validation

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 […]

Jul

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

By Bob Pollock Jul 30, 2019 Compounding FDA Medical Devices Regulatory Affairs User Fees

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 […]

Jun

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

By Pete Manger Jun 14, 2019 FDA Medical Devices Regulatory Affairs

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: […]

Apr

FDA Announces Enforcement Discretion for Postmarketing Safety Reporting of Combination Products

By Bob Pollock Apr 24, 2019 ANDAs BLA Combination Products FDA Medical Devices PMA Regulatory Affairs

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 […]

Mar

Young african american man sitting on couch in modern apartment with mouth open, holding utility bill with high rates, raised eyeglasses in wow or surprise gesture

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

By Bob Pollock Mar 05, 2019 Compliance FDA Generics Medical Devices New Drugs

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 […]

Feb

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

By Pete Manger Feb 13, 2019 FDA Medical Devices Regulatory Affairs

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 […]

Jan

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

By Bob Pollock Jan 22, 2019 ANDAs FDA Generics Medical Devices Regulatory Affairs

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 […]

Dec

Ricki Chase Publishes Article in MedTech Insight

By Bob Pollock Dec 18, 2018 Combination Products Compliance FDA Manufacturing Medical Devices

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 […]

Prev 1 … 4 5

Medical Devices