Industries
Other FDA-Regulated Products
Some organizations do not fit neatly into one product center. Our consultant network includes specialists across FDA's regulated product areas.
xFDA supports organizations whose operations span FDA product centers — combination products, HCT/Ps, blood and plasma establishments and multi-center sites — with quality systems, manufacturing controls, investigations, audits and remediation.
How we support this sector
Where engagements typically focus
- Combination products and 21 CFR Part 4 quality system requirements
- Human cells, tissues and cellular/tissue-based products
- Blood and plasma establishment compliance
- Food safety and preventive controls programs
- Tobacco product manufacturing practice requirements
- Multi-center facilities operating under a single quality system
If you are unsure which requirements apply to your operation, that question is itself a reasonable place to start a conversation.
When companies call us
Situations we are asked into
- A combination product needs a single quality system satisfying drug and device requirements.
- An establishment cannot determine which regulations apply to its operation.
- One site manufactures products regulated by more than one FDA center.
- A donor eligibility or tissue processing program needs independent review.
- Leadership wants a defensible scoping opinion before committing to a remediation program.
Questions we are asked
Other FDA-Regulated Products: common questions
Direct answers from the consultants who do this work.
- How does a combination product quality system work?
- Under 21 CFR Part 4 a manufacturer may operate a drug cGMP system and add the specified device provisions, or operate a device quality system and add the specified drug provisions. The practical work is deciding which base system fits the operation and integrating the additional elements honestly.
- What if we do not know which requirements apply to us?
- That determination is a legitimate first engagement. It is based on the product, its intended use, claims and how it is manufactured — and getting it wrong is more expensive than the assessment.
- Can one quality system cover multiple product types?
- Often yes, provided product-specific requirements are addressed explicitly rather than assumed. Shared systems fail when the most demanding requirement is not applied where it belongs.
- Do you support HCT/P establishments?
- Where consultant experience supports it, including donor eligibility documentation, processing controls, environmental controls and investigation practice.
- How do you scope an engagement in an unusual sector?
- With a short scoping conversation, a review of what the operation actually does, and confirmation that a consultant with verified relevant experience is available. If there is no genuine fit, we say so.
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