FDA pathway assessment

Answer a few questions to get an estimate of your likely FDA pathway, the standards that typically apply, FDA fees and recommended next steps. It takes about 3 minutes.

1. Your device

Briefly describe the device and its intended use

If the device fails or is used incorrectly, what is the worst likely outcome?

Minor or reversible injuryNo injury, only inconvenienceSerious, permanent or life-threatening harm

Is there a similar device already legally sold in the U.S.?

Not sureYesNo

2. Characteristics

Patient contact

Contact duration

Uses new technology or a new intended useElectrically powered or battery operatedContains software or firmware (or is software)Connects to a network, Bluetooth, Wi-Fi or the cloudUses AI / machine learningSupplied sterileReusable (cleaned or reprocessed between uses)Used at home by patients or caregivers

3. Your company

Country of manufacturer

Annual revenue (USD, optional)

Name (optional)

Email (optional, so we can follow up)

Company (optional)

MedCove

We help medical device companies turn innovative ideas into market-ready products, navigate FDA requirements, and successfully enter the U.S. market.

Services

Regulatory Strategy & FDA Pathway
Quality Management Systems
Medical Device Design & Development
Verification & Validation
Manufacturing & Process Development
FDA Submissions
FDA Pre-Submissions

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