By Chuck Seegert, Ph.D.
The FDA has released a list of guidance documents that it is planning to publish and develop in fiscal year 2015. The documents are divided into the A-list, which the agency fully intends to publish, the B-list which it will publish as resources permit, and a list of final guidance documents released historically that may require retrospective review.
As its annual priorities are established, the FDA’s Center for Devices and Radiological Health (CDRH) has published its plans for how it will prioritize guidance development in the coming fiscal year. While the agency intends to publish all guidance documents on the A-list and B-list, resource constraints may prevent some of them from being issued. The list is published to give insight into the CDRH’s current priorities, and all three lists will be updated annually.
This year’s list includes some guidance documents particularly relevant to the medical device space. For example, the agency intends to finalize the expedited premarket approval guidance document for high-need devices, which is designed to allow certain devices to move more quickly through the approval process.
The annual publication of the list started after the Medical Device User Fee Amendments (MDUFA) of 2012 was passed, according to an article on Med Device Online. Because manufacturers were providing greater funding to the agency, the FDA agreed to meet several goals that were both quantitative and qualitative in an attempt to get devices to the market more quickly.
Here is a quick highlight of the A-list final guidance topics and A-list draft guidance topics for 2015:
A-list Final Guidance Topics For 2015:
- Applying Human Factors & Usability Engineering to Optimize Medical Device
- 510(k) Submissions for Medical Devices that Include Antimicrobial Agents
- Balancing Premarket and Postmarket Data Collection for Devices Subject to
- Expedited Access for Premarket Approval of Medical Devices Intended for
Unmet Need for Life Threatening of Irreversibly Debilitating Diseases or
- Framework for Regulatory Oversight of Laboratory Developed Tests
- FDA Notification and Medical Device Reporting for Laboratory Developed Tests
- Coronary Drug Eluting Stents — Nonclinical and Clinical Studies
- Intent to Exempt Certain Class II and Class I Reserved Medical Devices From
Premarket Notification Requirements
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and
- Safety Considerations for 510(k) Submissions to Mitigate the Risks of
Misconnections With Small-bore Connectors Intended for Enteral Applications
- Submission and Review of Sterility Information in 510(k) Submissions for
Devices Labeled as Sterile
- Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation
and Testing (Biocompatibility)
A-List Draft Guidance Topics For 2015:
- General Wellness Products
- Medical Device Accessories
- Medical Device Decision Support Software
- Benefit-Risk Factors to Consider When Reviewing IDE Submissions
- UDI Direct Marking
- Informed Consent: Policy for Observational Data Used to Fulfill Device
- Adaptive Design for Medical Device Clinical Studies
- UDI FAQs
Comments may be submitted by industry and the public to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov . Comments must be identified with docket number FDA-2012-N-1021.