Device Archives

Does Your Data Integrity Risk Assessment Assess Full-Scale Instrument Deflection? It Should!

By Patrick Day Dec 23, 2025 ANDAs Biosimilars Compliance Data Integrity Device NDA Risk Management

Why Using Full-Scale Deflection Introduces Data Integrity Risks In pharmaceutical manufacturing, Accuracy is a critical ALCOA+ principle that can sometimes get lost, particularly when assessing the holistic system. The field instrument level needs to be adequately integrated into the overall assessment, especially in aseptic manufacturing environments where sterilization is critical (and accurate data, such as […]

Sep

caucasian person holds snus tobacco pouch over black background. copy space. alternative chewing nicotine smoking.

FDA Asks for Action Regarding Authorized Nicotine Pouch Products

By Bob Pollock Sep 04, 2025 Child resistant packaging Device Regulatory Affairs

Citing an increase in “accidental, harmful exposure” among children, the FDA is urging firms to use childproof packaging to help reduce the risk of such events. The notice (here) indicates that over the period “[f]rom April 1, 2022, to March 31, 2025, the number of reported nicotine pouch exposure cases reported to U.S. Poison Centers steadily increased. […]

Aug

toy Monarch butterfly emerging from its chrysalis.

Protocol Design and Lifecycle Following the Draft ICH Stability Guidance

By Joseph Posada Aug 01, 2025 Biologics Biosimilars Compliance Device FDA Generics NDA Stability

As discussed in a recent Lachman blog Revised Q1 Draft Stability Document Issued by FDA, the draft guidance titled Q1 Stability Testing of Drug Substances is a consolidated revision of ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C. This draft guidance provides guidance on product categories, such as advanced therapy medicinal products, vaccines, and other […]

Jul

FDA Issues Final Guidance on Medical Device User Fee - Lachman Blog

FDA Issues Final Guidance on Medical Device User Fee Small Business Qualification and Determination

By Bob Pollock Jul 30, 2025 Device Regulatory Affairs

The FDA has revised its previous guidance of the same name, which was issued on August 1, 2018. The FDA notes that “[a] draft select update to this document was issued on February 22, 2024.” The revised final guidance (Medical Device User Fee Small Business Qualification and Determination) “includes updates that describe how FDA will determine if […]

Jun

Do More with Less – Looks Like That Is What the FDA Budget Request Asks

By Bob Pollock Jun 03, 2025 ANDAs Biologics Biosimilars BLA Compliance Device Dietary Supplements FDA Generics NDA OGD OTC Regulatory Affairs

Now, here is a head scratcher. According to the Pink Sheet article written by Sue Sutter (here), “The White House requested $6.76bn, a decrease of 3.9%, or $271.5m, from the FY 2025 funding level. The proposal includes $3.17bn in budget authority, a decrease of 11.4%, and $3.59bn in user fees, a 4% increase.” What a dandy, […]

May

Two Chinese Testing Labs Come Under Serious FDA Scrutiny

By Bob Pollock May 22, 2025 ANDAs Compliance Data Integrity Device Medical Devices

Today, May 22, 2025, “[t]he U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) issued General Correspondence Letters to two third-party testing companies in China after discovering data that was falsified or otherwise found to be invalid” (see the FDA announcement here). The two labs receiving the so-called General Correspondence Letters are […]

Nov

Close up of hand touching smartwatch with health app on the screen, gadget for fitness active lifestyle.

The Future of Devices and Impact on Health Outcomes

By Deanna Anderson Nov 08, 2024 Device FDA Regulatory Affairs

The 2024 MedTech Conference in Toronto provided some great insights on what the future of medical devices can offer, particularly when utilizing AI technology. One area making great progress is the use of wearables. Who knew my Apple watch could be so useful?! There were multiple presentations on pairing wearable devices with mobile apps. This […]

Sep

Shot of an asian businessman shouting into a megaphone against a studio background

Now Hear This!

By Bob Pollock Sep 13, 2024 Device Regulatory Affairs

Reviewed “under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device,” the Agency has approved an OTC software solution that is compatible with certain Apple AirPods Pro headphones and provides, according to the FDA release […]

Aug

Navigating Future Quality and Regulatory Challenges for Medical Device Companies - Lachman Blog

Navigating Future Quality and Regulatory Challenges for Medical Device Companies: Understanding the FDA Quality Management System Regulation (QMSR)

By David Day and Deanna Anderson Aug 27, 2024 Compliance Device FDA Regulatory Affairs

The FDA’s long-awaited QMSR will be released in February 2026. The amended 21 CFR 820 will incorporate by reference the Quality Management System (QMS) requirements of the 2016 edition of ISO 13485. We will explore the key differences between an FDA inspection and a notified body audit as well as the distinctions between ISO 13485 and the QMSR. […]

Aug

Solving the Puzzle of Single-Use Consumables

By Marian Meyer and Tony Polletta Aug 20, 2024 ANDAs Biologics Biosimilars Compliance Device FDA Generics NDA Regulatory Affairs Validation

Although the FDA’s regulatory requirements for acceptance of vendor test results in lieu of testing is clearly specified in 21 CFR 211.84 for incoming raw materials and container closures, the FDA has not put forth specific regulations for the acceptance of single-use consumables. Biologics manufacturers may use dozens or even hundreds of different single-use consumables […]

1 2 … 4 Next

Device