The US Food and Drug Administration (FDA) has published a list of 23 medical device guidance documents it plans to publish during fiscal year 2013, part of the recently passed FDA Safety and Innovation Act (FDASIA).
Among FDASIA's numerous provisions is the Medical Device User Fee Act (MDUFA), which established the fees and regulatory expectations for the medical device review process. As of right now, those processes largely exist in the abstract, awaiting further development from FDA's Center for Devices and Radiological Health (CDRH).
That development plan has now received some clarity thanks to a list of all draft and final guidance documents to be published in the next 12 months, required under MDUFA and posted to FDA's website on 26 November 2012.
Currently, the guidance documents are divided into three groups: Priority 'A' guidance documents, Priority 'B' guidance documents and documents to be withdrawn.
The Priority 'A' documents are those which FDA deems necessary to issue in 2013, and are deemed more important than the secondary, Priority 'B' documents.
There are 18 Priority 'A' guidance documents in all-13 planned final guidance topics and 5 draft guidance topics. Some of the prioritized guidance documents have already entered states of proposal and review, including FDA's eCopy program and its Refuse to Accept (RTA) policy for 510(k) submissions.
Final Guidance 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
- Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents
Draft Guidance Topics:
- Distinguishing and Reporting Medical Device Recalls from Product Enhancements
- Types of Communication During the Review of Medical Device Submissions
- FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions
Priority 'B' Guidance Documents
FDA said it is also planning five Priority 'B' guidance topics, including one final guidance and four draft guidance topics. While FDA still intends to publish these documents, it noted that the workload of its staff often dictates the number of documents it is able to publish.
"Staff are frequently diverted from guidance development to other activities, including review of premarket submissions or postmarket problems," FDA wrote. "In addition, CDRH is required each year to issue a number of guidance documents we cannot know about in advance. These may involve newly identified public health issues as well as special control guidance documents that are necessary for the classification of de novo devices."
Still, if all goes according to plan, FDA said it plans to publish the following:
Final Guidance Topics
- Finalizing existing draft guidance documents.
Draft Guidance Topics
- Benefit-Risk Determinations in Premarket Notifications (510(k)s)
- Direct to Consumer (DTC) Genetic Testing: IVDs
- Transfer of Ownership of a Premarket Notification (510(k)) - Questions and Answers
- Custom Devices
In With the New, Out With the Old…
A final guidance, The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program, was withdrawn by FDA on 19 November 2012, and was the only guidance document FDA said it planned on withdrawing during the 2013 fiscal year.
The agency is calling for comments on the list of guidances, and in particular on its prioritization of certain documents over others and draft language for guidance documents. Comments will be accepted throughout the year.