Regulatory & Submissions · IDE Support
IDE Support — Manufacturing and Quality for Investigational Devices
The short answer
An IDE requires a description of how the investigational device is made and controlled, and design controls apply even though the device is not yet cleared. We build the manufacturing and quality content and set up the sponsor oversight that keeps clinical builds consistent.
Why this matters
- Investigational builds performed outside design control create records problems that surface at 510(k) or PMA stage.
- Device changes during a study must be assessed and documented, or the clinical data becomes hard to attribute.
- Sponsors are responsible for the quality of devices shipped to investigators.
Applicable regulations and standards
- 21 CFR Part 812
- Investigational device exemptions: sponsor responsibilities and application content.
- 21 CFR 820.30 / QMSR design controls
- Design controls applicable to investigational devices.
- ISO 14971
- Risk management supporting the investigational risk analysis.
What our consultants actually do
- Draft manufacturing and quality content for the IDE application
- Establish design control and change assessment practices for investigational builds
- Set up device accountability, labeling and shipment records for study sites
- Assess contract manufacturers building clinical units
- Prepare the design history file to carry forward into the marketing submission
Across the product lifecycle
01 / DEVELOP
Design inputs and risk analysis established before clinical builds.
02 / SCALE
Clinical build process documented and repeatable.
03 / TRANSFER
Build instructions transferred and controlled.
04 / VALIDATE
Verification appropriate to investigational status.
05 / MANUFACTURE
Controlled clinical unit production with accountability records.
06 / MAINTAIN
Change assessment during the study, carried into the DHF.
Problems we are usually called about
- Clinical units built to engineering drawings with no controlled build record
- Device modifications during the study with no impact assessment
- Device accountability records reconstructed after the fact
Typical deliverables
- IDE manufacturing and quality sections
- Design control procedures suited to investigational stage
- Device accountability and labeling system
- DHF readiness assessment for the future marketing submission
Frequently asked
- Do full QMSR requirements apply during an IDE?
- Design controls apply. The rest of the quality system applies proportionally, and the practical goal is to build records now that the marketing submission can rely on later.
References
More for regulatory & submissions
Technical, manufacturing and quality support for US FDA submissions — written by people who have reviewed and inspected against them.
- 510(k) SupportA 510(k) is an argument for substantial equivalence, supported by evidence your quality system has to be able to produce on demand.
- PMA SupportA PMA is reviewed alongside a pre-approval inspection of the manufacturing site, which means the manufacturing section is not paperwork — it is a description of a facility that will be examined.
- De Novo SupportA De Novo asks FDA to create a classification, which means the submission has to propose the controls that will make the device type safe and effective.
- IND SupportFor an IND, the section that most often holds up a program is CMC.
- NDA SupportBy NDA, the manufacturing story has to be complete: a justified control strategy, validated process, qualified methods and a site that can demonstrate all of it during a pre-approval inspection.
- ANDA SupportGeneric applications are decided as much on manufacturing quality and data credibility as on bioequivalence.
- BLA SupportFor a biologic, the process is a substantial part of the product.
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