Navigating the 510(k) Clearance and PMA Approval Process
Introduction There are two main paths that medical device manufacturers can use to bring moderate- and high-risk devices to market with the FDA’s permission: through submittal of a premarket approval (PMA) request or 510(k) application. Submitting a PMA application is a more extensive approach, requiring substantial evidence that provides “reasonable assurance that the device is safe and effective” through methods like clinical trials, and results in FDA “approval ...
Jan. 7, 2019
The FDA’s Adoption of ISO 13485: What Medical Device Manufacturers Should Know
IntroductionAs globalization of medical device supply chains has continued to increase, regulatory bodies have grappled with how to bridge the gap between domestic and foreign regulation. Without a unified approach to both, the daily practice of ensuring that regulatory processes are followed and properly documented is even more challenging. The announcement that the FDA plans to use ISO 13485 as the basis for its quality system legislation signals an important ...
Dec. 19, 2018
Three Quality Subsystem Improvements That Streamline FDA Compliance
IntroductionMaintaining readiness for FDA inspections can be arduous and time-consuming, and the need for preparedness is growing. While the FDA continues to issue more observations than Form 483s, the number of observations has been decreasing, while the count of Form 483s has been increasing. A renewed focus on the quality subsystems that are most frequently cited with issues in Form 483 inspections can streamline FDA compliance and inspection readiness. Here ...
Dec. 10, 2018
Eliminate Barriers to Innovation Part IV
Connecting Products and Projects Helps Streamline Regulatory Compliance This is the fourth and final part of our series on how to break down the barriers to product innovation. We have demonstrated how to connect disparate product teams with a single source of truth to simplify collaboration, streamline new development, and keep up with engineering changes. Now we will discuss tips on how to create and maintain a proactive project management ...
Dec. 5, 2018
Eliminate Barriers to Innovation Part III
Meeting Product Requirements and Streamlining Engineering Changes Throughout this series, we have been exploring how manufacturers can streamline new product development and new product introduction (NPDI) by connecting the entire new product team with a centralized product record for a single source of truth. During the first installment, we covered the challenges product companies face in delivering a new product to market. And in part two we shared tips on ...
Nov. 27, 2018
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