Best Practices for Selecting Predicate Devices in 510k Submissions (DRAFT)
This guidance provides recommendations for selecting predicate devices in 510(k) submissions. It aims to improve the predictability, consistency, and transparency of the 510(k) premarket review process by establishing best practices for predicate device selection. The guidance is meant to be used alongside the 510(k) Program Guidance without changing existing statutory and regulatory standards for substantial equivalence evaluation.
This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What are the four best practices for selecting a predicate device in a 510(k) submission?
The FDA recommends selecting predicate devices that: (1) were cleared using well-established methods, (2) meet or exceed expected safety and performance, (3) have no unmitigated use-related or design-related safety issues, and (4) have no associated design-related recalls.
How should manufacturers search for adverse events related to potential predicate devices?
Manufacturers should search the MAUDE Database, Medical Device Reporting (MDR) Database, and MedSun Reports Database for any reported injuries, deaths, or malfunctions associated with potential predicate devices before making their selection.
What constitutes “well-established methods” when evaluating predicate devices?
Well-established methods include those from FDA-recognized voluntary consensus standards, FDA guidance documents, qualified medical device development tools (MDDTs), or widely accepted methods published in scientific literature or found acceptable through previous premarket submissions.
Should manufacturers always avoid older predicate devices in favor of newer ones?
Not necessarily. While newer devices may have modern safety features, older devices might have established long-term safety data. The focus should be on the four best practices rather than just the age of the predicate device.
What information should be included in the 510(k) Summary regarding predicate selection?
The 510(k) Summary should include a narrative explaining how the four best practices were used to select the predicate device, and if no ideal predicate exists, describe how known concerns were mitigated in the subject device.
Where can manufacturers find information about design-related recalls for potential predicate devices?
Manufacturers should search the Medical Device Recalls Database, which includes recalls classified since November 2002, to assess whether any potential predicate devices have been subject to design-related recalls that could indicate fundamental design flaws.
What You Need to Do 👇
Recommended Actions
- Search FDA databases to identify potential predicate devices with same intended use
- Review predicate device safety and performance by:
- Checking MAUDE, MDR, and MedSun databases for adverse events
- Reviewing Medical Device Safety website for emerging signals
- Searching Medical Device Recalls Database
- Evaluating test methods used for clearance
- Document predicate selection process including:
- Analysis of well-established test methods used
- Safety and performance history review
- Assessment of any safety issues or recalls
- Rationale for final predicate selection
- Include predicate selection narrative in 510(k) Summary explaining:
- How best practices were applied
- Any known issues with selected predicate
- Mitigations implemented in subject device
- If no predicates meeting best practices are available:
- Document why in 510(k) submission
- Describe additional testing/mitigations implemented
- Include explanation in 510(k) Summary
Key Considerations
Non-clinical testing
- Select predicate devices cleared using well-established methods from:
- FDA-recognized voluntary consensus standards
- FDA guidance documents
- Qualified medical device development tools (MDDT)
- Widely accepted methods published in public domain/scientific literature
- Consider if test methods used for predicate device remain appropriate for subject device evaluation
Human Factors
- Consider any unmitigated use-related safety issues associated with predicate devices
- Review safety communications and emerging signals related to use-related issues
Labeling
- Review predicate device labeling for any safety-related updates or modifications
- Consider if labeling adequately addresses known safety concerns
Safety
- Select predicates that meet or exceed expected safety performance
- Avoid predicates with:
- Unmitigated design-related safety issues
- Design-related recalls
- High frequency of adverse events
- Review safety databases (MAUDE, MDR, MedSun) for reported issues
- Consider emerging safety signals and communications
Other considerations
- Include narrative in 510(k) Summary explaining predicate device selection process
- Document how best practices were applied in predicate selection
- If using predicate with known issues, describe mitigations in subject device
- Consider duration of safe clinical use for implants and long-term devices
Relevant Guidances 🔗
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- The Abbreviated 510k Program: Using Guidance Documents, Special Controls, and Standards for Substantial Equivalence Demonstration
- Special 510k Program for Device Modifications: Eligibility Criteria and Submission Requirements
- MDUFA Performance Goals and Processing of 510k Submissions
- User Fees and Refunds for 510k Submissions
Related references and norms 📂
- ISO 13485: Medical devices – Quality management systems for regulatory purposes