FDA Third Party Review Programs
In August 1996, the FDA launched what was known as the Voluntary Third Party 510(k) Review Pilot Program. The program’s aim was to test out the usage of third parties for performing primary reviews of some medical devices under the 510(k) process in order to improve speed and efficiency. The limitation of the device eligibility was […]
FDA ESTABLISHES A NEW DIGITAL HEALTH ADVISORY COMMITTEE
The world of technology is moving at lighting speed. We are experiencing advances in software capabilities, interactions with automated services, and a far greater emphasis on how we are becoming more reliant on digital processes in our everyday lives. Case in point, when was the last time you were able to actually talk to a […]
FDA UPDATE: FINAL GUIDANCE SUBMISSION AND REVIEW OF STERILITY INFORMATION IN PREMARKET NOTIFICATION (510(K)) SUBMISSIONS FOR DEVICES LABELED AS STERILE
On Jan. 8, 2024, the FDA updated the final guidance on “Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile”. Within the document, the FDA announces that it has recategorized vaporized hydrogen peroxide (VHP) to be an Established Category A sterilization process. As such, this places VHP in the same […]
FDA Changes Guidance on the Use of ISO 10993-1:2016
ISO 10993-1 is recognized as the gold standard when it comes to the selection of applicable biological testing of medical devices and the associated risk assessment, while also providing valuable information pertaining to the potential need for additional testing based on available data. In 2020, the FDA updated the guidance document ‘Use of International Standard […]
FDA’S LABORATORY DEVELOPED TESTS ENFORCEMENT RULE
Laboratory developed tests (LDTs) are in vitro diagnostic devices (IVDs) for use in clinical settings and play a vital role in the health industry. LDTs are still regulated by the federal government, via the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) under the Public Health Service Act. Laboratories […]
510(k) Clearance
510(K) CLEARANCE CASE STUDY CHALLENGE:The manufacturer of a new laser-resistant endotracheal tube device needed to use an older predicate for their 510(k) submission to the FDA. While still commercially available, the predicate device was over 20 years old at the time of submission, with limited regulatory information and test data available. FDA often imposes closer […]
Regulatory Strategy
REGULATORY STRATEGY CASE STUDY CHALLENGE:A large international medical diagnostic system equipment manufacturer was beginning to see the fruits of a technology development collaboration with Boston-area medical research institutions. Having set up a subsidiary company in the US to commercialize these technologies, the company needed: APPROACH:AlvaMed proposed a project with: The 3-month, $60,000 project assessed the […]
US Agent Services
FDA US AGENT CASE STUDY CHALLENGE:A startup company in France successfully completed their US market clearance for an imaging device and selected a US distributor. After registering their manufacturing establishment in France with the FDA, the company became aware of the FDA’s requirement to appoint a US Agent. Their distributor was unwilling to take on […]
FDA Registration
FDA REGISTRATION CASE STUDY CHALLENGE:A small start-up company had achieved their second round of funding to commercialize custom dental surgical guides. The company manager had no prior experience in the medical device industry and very limited bandwidth. The company also had no supporting quality or regulatory resources. Facing the task of registering the product and […]
