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 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 […]
MDCG UPDATES Q&A ON IMPORTERS AND DISTRIBUTORS
The Medical Device Coordination Group (MDCG), the regulatory body that works toward ensuring the safe and effective use of medical devices in Europe, recently updated a Q&A document on how both the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) apply to importers and distributors. Under both regulations, an economic operator is defined […]
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 […]
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 […]
UPDATES TO Q-SUB GUIDANCE PRIOR TO RELEASE OF NEW PRE-SUB DRAFT GUIDELINES
The Q-Submission Program, also known as the Pre-Submission Program, is an initiative by the U.S. Food and Drug Administration (FDA) aimed at facilitating the development and review of medical devices. It provides an opportunity for medical device manufacturers to interact with the FDA before submitting their formal applications, allowing for early feedback and guidance. The […]
FDA’S NEW DRAFT GUIDANCE FOR HUMAN FACTORS INFORMATION IN MARKETING SUBMISSIONS
In December of 2022, the FDA released draft guidance[1] to aid medical device manufacturers in determining what information should be included in marketing submissions for medical devices using a risk-based approach. The guidance outlines how to determine a submission category, each category requires different amounts of documentation. This framework aims to improve the efficiency of FDA […]
