Who We Serve: Technology
Combination Products
A prefilled syringe, a drug-coated device or an autoinjector has to satisfy more than one quality framework at once. Most gaps sit at the interface between the constituent parts, where the drug team and the device team each assume the other owns the record. We help combination product makers find those seams.
Standards and Regulations to Know
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- ISO 13485Quality Management Systems for Medical Devices
- ISO 14971Risk Management for Medical Devices
- IEC 62366-1Usability Engineering for Medical Devices
- ISO 10993-1Biological Evaluation Within a Risk Management Process
- ISO 80369 SeriesSmall-Bore Connectors for Liquids and Gases in Healthcare
- 21 CFR Part 803Medical Device Reporting
Typical Regulatory Exposure
FDA assigns a combination product to a lead center based on its primary mode of action, the single mode that provides the most important therapeutic action of the product. That assignment shapes the premarket pathway and which part of FDA leads the review, but it does not remove the requirements that apply to each constituent part.
21 CFR Part 4 sets the current good manufacturing practice requirements for combination products, describing how drug and device requirements apply when constituent parts are combined. Firms need to show, in procedures and in records, how they meet the requirements that apply to each constituent part, including design and development and risk management for the device side.
Postmarket obligations also cross frameworks. Complaint handling, adverse event reporting and change management can carry requirements from both the drug and device sides, depending on how the product is regulated and who holds the application. Mapping those obligations explicitly before an inspection costs far less than reconstructing them during one.
Where Audits Find Gaps
- 01
No Map of Which Requirements Apply
The quality manual does not say which drug and device requirements govern which constituent part, so procedures cover one framework well and the other by accident.
- 02
Device Constituent Without Design Controls
The delivery device was sourced or adapted from a supplier, and the design file treats it as a purchased component rather than a design with its own inputs, verification and risk analysis.
- 03
Interface Testing Nobody Owns
Drug-device compatibility, dose accuracy and container closure testing belong to neither team's procedures, so they were run once and never revisited after later changes.
- 04
Use-Related Risk Underestimated
Patients or caregivers administer the product, but human factors work was scoped like a drug label review rather than a device usability program.
- 05
Reporting Paths Split by Team
Drug safety and device complaint handling run separately, with no defined process for deciding which reporting requirements a given event triggers.
Relevant Standards and Regulations
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- ISO 13485Quality Management Systems for Medical Devices
- ISO 14971Risk Management for Medical Devices
- IEC 62366-1Usability Engineering for Medical Devices
- ISO 10993-1Biological Evaluation Within a Risk Management Process
- ISO 80369 SeriesSmall-Bore Connectors for Liquids and Gases in Healthcare
- 21 CFR Part 803Medical Device Reporting
Relevant Services
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
Supplier Audits and Supplier Controls
Risk-based supplier selection, quality agreements, monitoring and supplier audits that hold up under QMSR.
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
CAPA System Remediation
Fixing a CAPA system auditors keep citing: the procedure, the records, root cause, effectiveness and backlog.
Audits and Inspections You May Face
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
FDA PMA Pre-Approval Inspection
An FDA inspection tied to a PMA application that checks your quality system and its match to the submission.
Supplier Audit
Audits you perform of your own suppliers and contract manufacturers as part of purchasing controls.
Questions
How is the lead center decided?
By the product's primary mode of action, the mode that provides its most important therapeutic action. Where that is unclear, firms can ask FDA's Office of Combination Products for a formal or informal determination.
Do we need two complete quality systems?
Not necessarily. 21 CFR Part 4 describes how drug and device requirements apply together, and the right structure depends on your product and your existing quality system. What matters is that each applicable requirement is clearly covered and backed by records.
We buy the device constituent from a supplier. Who owns the design records?
You remain responsible for the combination product, so you need enough design and risk information to show the device constituent meets its requirements in your product. Quality agreements and supplier controls are where that access is defined.
Combination Products
Get an Advisor's View of Your Quality System
Tell us about your devices and the audit or inspection ahead, and an advisor will scope an assessment for your kind of product. Please don't send confidential documents yet: secure upload is set up after onboarding.
