The FDA Medical Device Guidance Documents provide a great way to keep up with administrative protocols, requirements, and other technical aspects of working within that regulatory framework. If you’re in the medical devices field, you’ll welcome a newly released guidance. It’s titled “Types of Communication During the Review of Medical Device Submissions – Guidance for Industry and Food and Drug Administration Staff .” It replaces the earlier document, “Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements.” It provides FDA guidance on communication during MedDev submissions.
Four types of communication are reviewed:
- Acceptance Review Communication (used for premarket notification submissions (510(k)s), original premarket approval applications (Original PMAs), Panel-Track PMA Supplements, and Pre-Submissions)
- Substantive Interaction (for 510(k)s, Original PMAs, Panel-Track PMA Supplements, and 180-Day PMA Supplements)
- Interactive Review,
- Missed MDUFA Decision Communication (for 510(k)s, Original PMAs, and Panel-Track PMA Supplements)
For each type of communication, there’s discussion of why the FDA might want to communicate with you, when this type of communication might take place in the process, and what kind of data you can expect to receive. There’s also notes on procedural issues that might delay processing, like missing fees and so on.
There’s also help with identifying how to best respond to some communications you may receive from the FDA during your submission process. Further, the document will give you some examples of when you need to initiate communication with the FDA, either staff at CBER or CDRH. And best of all, there’s information in this FDA guidance document how things you can do to help make the various steps in the process more effective. Since time is money, and this process can be a daunting one, these hints are really helpful!
You’ll also want to review my blog.document-center.com today. I’ve listed the new FDA Guidance Documents released during the 1st Quarter 2014. Here you can find other publications that are appropriate for your business situation.
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