Visit with Lachman Consultants at Exhibit Hall E, Booth 626. We hope to see you at The MedTech Conference at the Metro Toronto Convention Center in Toronto, Canada, October 15-17, 2024. It features world-class speakers, a cross-cutting educational program, invaluable networking and next-level technology. This fast-growing event is a gathering of the world’s top medtech […]
The FDA has published its Medical Device User Fees for FY 2025 (here) and the reason there are no surprises is that the fees all went up. The new fees are effective on October 1, 2024. The Federal Register Notice (FR) “provides information on how the fees for FY 2025 were determined, the payment procedures you should follow, […]
Is your firm preparing for the wave of AI regulations, laws, white papers, and regulatory guidances? As reported in a previous Lachman blog, EU Artificial Intelligence (AI) Act: Impact on Pharma and MedTech, laws are emerging, but can companies keep up with the pace? Last year, the EU did what the U.S. has not been […]
The Agency warns patients not to rely on glucose levels measured by the above devices unless they are reporting glucose-level data generated from an FDA-authorized device for measurement of blood glucose by a device that pierces the skin. The Agency says that readings from devices that do not puncture the skin may provide unreliable glucose […]
Today, the FDA published a draft guidance document titled Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance (here) regarding the annual registration fee. When this draft is finalized, it will supplement the Medical Device User Fee Small Business Qualification and Certification Guidance and address the waiver provisions of the […]
As U.S. consumers are facing critical drug shortages, leading Congress to question the FDA’s foreign inspection program, particularly for products with supply chains from India and China, the oversight of CGMP inspections is high on the Agency’s radar. With approximately 32% of generic drugs and 45% of active pharmaceutical ingredients (APIs) from these two countries, […]
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 […]
