Free FDA Medical Device Regulatory Advisor

Explore FDA medical device questions with greater clarity.

Use the IMTS FDA Reg-Advisor to explore FDA medical device regulatory pathways, terminology, clinical evidence considerations, and submission requirements.

Launch the IMTS FDA Reg-Advisor

Free educational resource developed by Indus MedTech Solutions.

Start with a question

What can you ask the FDA Reg-Advisor?

Does my medical device require a 510(k)?

What is the difference between 510(k), De Novo, and PMA?

When is clinical evidence needed for a 510(k)?

Can real-world evidence support an FDA submission?

What is substantial equivalence?

How do I identify an appropriate predicate device?

What information is included in a 510(k) submission?

When might FDA recommend a Pre-Submission?

Ask the FDA Reg-Advisor

How it works

From question to informed next step.

01
Ask your question
Enter a question about an FDA medical device regulatory pathway, submission, terminology, or evidence requirement.
02
Explore the considerations
Review AI-assisted information that helps explain relevant FDA concepts and considerations.
03
Verify your strategy
Use the information as a starting point and confirm device-specific decisions against current FDA requirements or with qualified regulatory professionals.

Medical device focus

Built for FDA medical device regulatory questions.

The IMTS FDA Reg-Advisor is designed around medical device regulation rather than general pharmaceutical or life science information.

510(k) Premarket Notifications
De Novo requests
Premarket Approval (PMA)
FDA regulatory pathways
Predicate and substantial equivalence considerations
Clinical evidence
Real-world evidence
FDA Pre-Submissions
Medical device regulatory terminology

Developed by Indus MedTech Solutions

Medical device expertise behind the resource.

Indus MedTech Solutions provides medical and regulatory writing focused exclusively on medical devices, supporting established global manufacturers, midsized medical device companies, and emerging innovators.

IMTS supports FDA programs including regulatory writing, clinical evidence development, systematic literature reviews, clinical study documentation, and scientific publications.

Explore FDA Medical Device Writing Services

Frequently asked questions

Using the FDA Reg-Advisor.

Is the IMTS FDA Reg-Advisor free?

Yes. The tool is provided as a free educational resource for professionals working with medical devices.

Can the FDA Reg-Advisor determine my FDA regulatory pathway?

It can help users understand potential pathways and relevant considerations, but device-specific pathway determinations should be confirmed using current FDA requirements and, where appropriate, direct FDA interaction.

Does the FDA Reg-Advisor replace a regulatory consultant?

No. It is designed to help users explore regulatory concepts and questions. It does not replace device-specific professional regulatory advice.

Can it help with 510(k), De Novo, and PMA questions?

Yes. The tool is designed to address common questions relating to these FDA medical device pathways and associated evidence considerations.

Need expert FDA submission support?

Move from general information to device-specific execution.

IMTS provides specialist medical and regulatory writing and clinical evidence support for medical device companies.

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