Must-Know FDA Guidance Documents from 2017 (MD&DI)
FDA puts out a lot of information over the course of a year. Here’s what you absolutely need to know going into 2018.
In 2017, FDA issued several new and updated guidance documents, furthering the agency’s mission to advance public health by helping to speed innovation, and bring more effective and safe medical devices to the marketplace. Here are the documents that are important for medical device manufacturers and industry to know.
Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff
What FDA says: This revised guidance provides an overview on how manufacturers should engage with FDA regarding requests for agency feedback on issues relating to potential premarket applications and submissions. The document characterizes the feedback mechanisms and outlines information on the logistics for submission, receipt, tracking, and response to these requests.
Benefit: This guidance is a useful tool for obtaining FDA input on multiple pre-submission topics, including the regulatory path to market, the design of nonclinical, analytical and clinical testin...
