Dear HTM Professional,
The FDA has asked for help in answering some important questions about service, repair, refurbishment, and remanufacturing of medical devices. In its public notice in the Federal Register, the FDA notes that it is seeking comments from the widest range of interested persons: OEMs, third parties, healthcare delivery organizations, and any organization that has anything to do with refurbishing, reconditioning, rebuilding, remarketing, or remanufacturing medical devices.
I am writing because it’s my belief that the more information the FDA receives from organizations like yours, the better informed it will be. You and your organization can help, because you have expertise and firsthand knowledge to answer their questions.
AAMI has prepared talking points to help you talk with your colleagues and supervisors about the FDA’s request and think about what kind of information would be most helpful to provide. The FDA needs to hear from a broad cross-section of stakeholders in order to gain a balanced perspective on the issues. We encourage organizations such as yours to add your voice.
As you know, AAMI is a neutral and multidisciplinary organization. We believe that the best decisions in healthcare are made when all stakeholders are at the table. We will be filing comments to provide objective information to the FDA, but our focus will be on the entire industry, not any one specific domain. And, AAMI cannot answer a number of the questions being asked by the FDA because we are not in the field with the firsthand experience that your organization brings to the questions.
Please take the time to understand this issue and prepare informative comments. The FDA’s deadline is May 3, 2016. We hope the talking points help you think through your approach and comments and make it easy to have your internal conversations.
Thank you for everything you do to support the field of healthcare technology.
Kindest Regards,
EDITOR’S NOTE: Please join us for a FREE webinar on this topic at 2 p.m. ET on Thursday, March 31.