As with any regulatory submission, there are inherent risks associated with the submission and approval process if required data are incomplete or missing. In addition, compliance activities can play a major role in risks following approval and with commercialization of products. Some of the risks specific to 510(k)‑cleared devices include: Submission Rejection/Approvals: FDA 510(k) submissions […]
FDA 510(k) is a submission process that medical device manufacturers need to go through to receive clearance from the US Food and Drug Administration (FDA) in order to legally market their products in the US. The FDA 510(k) process is essential for ensuring public safety by confirming that medical devices meet the necessary standards and […]
Data integrity is not only fundamental to a company’s license to operate and to drive new stakeholder value. It’s simply smart business. Does your company have a sustainable, cost-effective global data governance program? Get the answers you need. Watch the following video and talk to Lachman Consultants. The primary purpose of this message is solely […]
A strong organizational culture is essential for maintaining the quality and integrity of your company’s data. Does your company have a data-integrity-centric culture? Get the answers you need. Watch the following video and talk to Lachman Consultants. The primary purpose of this message is solely to educate and inform. Lachman Consultants Services, Inc. assumes no […]
Episode #4 of our six-part Data Integrity video series focuses on Systems and Processes, two more essential elements for minimizing and eliminating data integrity issues. The video explains the four key points of Systems and Processes necessary for establishing a world-class data integrity program and the two primary controls that well-established Systems and Processes provide. […]
All indications seem to be that all the User Fee reauthorizations (loving known as the UFAs) will be passed in a fairly clean bill by the end of the week. This is great news for FDA employees and for industry; however, we sure hope that they tell us what to do as that will basically […]
Our latest video in the Lachman Consultants Data Integrity Series, “People and Organization – The First Essential Elements of a World-Class Data Integrity Program” reveals how good people and organization practices can have a most pronounced impact on reducing your overall data integrity risk. How well is your company incorporating people and organization into its […]
Traditionally, data integrity programs have focused on electronic systems, but to keep pace with the industry, your company must evolve. Achieving digital maturity requires companies to develop a multi-dimensional program of governance for their data. Learn what a well-conceived program that achieves lasting data integrity consists of. “The primary purpose of this message is solely […]
In a Federal Register notice titled Effects of the COVID‑19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices–Questions and Answers (Revised); Withdrawal of Guidance (Docket No. FDA-2020-D-1138), which appeared in the prepublication section (usually meaning it will become official the next day but, because of the weekend, the final publication […]
FDA warning letters have doubled since 2015 and more than 50% of observations involve data integrity. Fines up to $1 million per incident are possible. Get prepared and avoid the fines. “The primary purpose of this message is solely to educate and inform. Lachman Consultants Services, Inc. assumes no liability for the accuracy and completeness […]
