FDA Reveals Topics for Future Guidance Documents
Over the next year, the U.S. Food and Drug Administration intends to weigh in with guidance documents on premarket approval applications, mobile medical applications, the appeals process, and a host of other issues likely to strike a chord with medical device manufacturers.
The FDA announced its “guidance development” plans for fiscal year 2013 in a posting on its website and invited the public to submit comments on the lists. There are two lists: The “A” list covers guidance documents that the agency, through its Center for Devices and Radiological Health (CDRH) “fully intends to publish,” while the “B” list covers items that will be published only as time and resources allow.
The drafting and release of the lists is a result of the renewal this past summer of the medical device user fee program. In return for additional funding from the manufacturing industry, the FDA agrees to reveal more about its plans and allow stakeholders time to comment on those plans.
“The lists are intended to provide helpful information about CDRH’s current priorities for the upcoming fiscal year,” the agency said. “CDRH plans to update these lists every year.”
The “A” list of planned medical device guidance documents includes these topics:
- Refuse to Accept (RTA) Policy for 510(k) Submissions
- Acceptance and Filing Review for Premarket Approval Applications
- Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
- In Vitro Companion Diagnostic Devices
- Design Considerations for Pivotal Clinical Investigations for Medical Devices
- De Novo Classification Process (Evaluation of Automatic Class III Designation)
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
- CDRH Appeals Processes
- Medical Device Classification Product Codes
- The Pre-Submission Program and Meetings with FDA Staff
- Mobile Medical Applications
- eCopy
- Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents
To see all of the topics on both FDA lists and to find out how to submit comments, click here.
Posted: November 27, 2012