Bundling Multiple Devices and Multiple Indications in Medical Device Submissions
This guidance provides recommendations on when it is appropriate to bundle multiple devices or multiple indications for use in a single premarket submission (510(k), PMA, or BLA) for FDA review and user fee payment purposes. It aims to help industry and FDA staff determine when bundling may be appropriate while ensuring efficient reviews and timely decisions.
Recommended Actions
- Evaluate if devices/indications present similar scientific and regulatory issues that can be reviewed efficiently together
- Consider whether:
- Supporting data is similar
- One review division will be involved
- Devices/indications are similar
- For bundled submissions:
- Provide complete information required for each device/indication
- Include appropriate forms for each device if indications differ
- Reference previous submissions when applicable
- Clearly identify all affected submissions in cover letter
- Contact appropriate review division for specific bundling questions before submission
- Do not add devices/indications after review has begun
- If bundling is deemed inappropriate by FDA:
- Consider withdrawing problematic device/indication
- Submit separate application
- Appeal decision if warranted
- For IVDs, carefully evaluate specific considerations regarding multiple analytes, reagents, intended uses and sample matrices
Key Considerations
Clinical testing
- Clinical data should be similar/applicable across bundled devices/indications
- Multiple indications in one PMA generally not appropriate unless supported by same clinical data
- For IVDs, dissimilar sample matrices should not be bundled due to different clinical data requirements
Non-clinical testing
- Supporting pre-clinical data should be similar across bundled devices
- For reprocessed SUDs, validation data must demonstrate safety/effectiveness after maximum reprocessing cycles
Software
- Software changes affecting multiple devices may be bundled if reviewable in one review
Labelling
- Certain labeling changes may be bundled for multiple devices if change is common (e.g. packaging instructions)
- Must provide updated labeling addressing all devices/indications in bundle
Other considerations
- Devices should present scientific/regulatory issues that can be efficiently addressed in one review
- Generally appropriate to bundle:
- Multiple devices within same generic type
- Devices used together in a procedure
- Changes affecting multiple devices using same processes
- Generally not appropriate to bundle:
- MDUFA Performance Goals and Processing of 510k Submissions
- FDA Actions on Premarket Approval Applications (PMAs) and Effects on MDUFA Review Goals and Timelines
- 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
Related references and norms
- 21 CFR § 807.87: Requirements for 510(k) submissions
- 21 CFR § 814.20: Requirements for PMA submissions
- 21 CFR § 860.3(i): Definition of generic type of device
- 21 CFR § 10.75: Internal review of decisions
Original guidance
This post is licensed under CC BY 4.0 by the author.