FDA’s Center for Device and Radiological Health (CDRH) issued a list of guidance documents it intends to publish in 2015, as well as other changes to its priorities, such as a retrospective review of previously-issued final guidance documents and a new guidance document database.
Pertinent topics for orthopaedic device companies include the following.
Final Guidance Topics
- Applying Human Factors & Usability Engineering to Optimize Medical Device Design
- Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval
- Intent to Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification Requirements
- 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)
Draft Guidance Topics
- Medical Device Accessories
- Medical Device Decision Support Software
- Benefit/Risk Factors to Consider When Reviewing IDE Submissions
- UDI Direct Marking
- UDI FAQs
- Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements
- Adaptive Design for Medical Device Clinical Studies
FDA’s new initiative to post previously-issued final guidances intends to determine whether past guidances should be updated or withdrawn by gathering external feedback from stakeholders. CDRH seeks feedback this year on whether any final guidances issued in 1985, 1995 or 2005 should be revised or withdrawn. In 2016, CDRH plans to list the final guidance documents issued in 2006, 1996 and 1986, and so on, through 2025 to assess the applicability of all guidances older than ten years.
Further, last month, FDA made improvements to its guidance document database, including a unified database with a simplified search function.
For FDA’s B-list priorities and past guidance documents up for review, click here.