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.
What You Need to Know? 👇
What is bundling in medical device submissions and when is it appropriate?
Bundling refers to including multiple devices or indications in a single premarket submission for review and user fee payment. It’s appropriate when devices present scientific and regulatory issues that can be efficiently addressed during one review, with similar supporting data and primarily one review division involved.
Can I bundle different generic device types in a single 510(k) submission?
Yes, in some cases you may bundle differing generic device types in a single 510(k). This is appropriate when devices are used together during therapeutic/diagnostic procedures, when one device is an accessory to another, or for convenience kits and device systems.
What are the user fee implications of bundling under MDUFMA?
Under MDUFMA, there is one user fee per submission regardless of how many devices are bundled. Inappropriate bundling can affect user fee revenues and may require fee adjustments for all regulatory submissions. Proper bundling helps ensure fee stability and meeting review performance goals.
Can I bundle multiple indications for use in a single PMA submission?
Generally no, you should not bundle multiple indications in one PMA because each indication typically requires significant clinical data and review resources. Bundling may be appropriate only if much of the supporting data (especially clinical data) would be the same for all indications.
What happens if FDA determines my bundled submission is inappropriate?
FDA will notify you in writing and request withdrawal of the inappropriately bundled device or indication. The application will be placed on hold. You can resubmit separately, withdraw the problematic item, withdraw the entire application, or appeal the decision per 21 CFR § 10.75.
Are there special considerations for bundling in vitro diagnostic devices?
Yes, IVD devices have specific bundling considerations including: multiple analytes can be bundled when using same analytical/clinical data; multiple reagents for profiles may be bundled; dissimilar sample matrices should not be bundled; and antimicrobial susceptibility testing should include only one drug per submission.
What You Need to Do 👇
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:
- 510(k) with PMA devices (with some exceptions)
- Different generic types in one PMA
- Devices reviewed by different divisions
- Multiple indications in one PMA
Relevant Guidances 🔗
- 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