Tools and resources
Practical tools and references for medical device teams, from shelf-life calculations to the standards and FDA documents we work with every day.
FDA device and pathway checker
Answer a few questions to see whether FDA would likely treat your product as a medical device, which class it falls in, and which premarket submission it would need.
- Is it a device?
- Which class?
- Which submission?
Step 1 of 3 · Is it a device?
What is your product intended to do?
FDA looks at intended use: what you claim the product does, in labeling, marketing and on your website.
For education only, not a regulatory determination. Classification depends on your exact intended use and product code, and FDA makes the final call.
Accelerated aging time calculator
Estimate how long samples need in the chamber to simulate a target shelf life, using the Arrhenius-based method in ASTM F1980.
Accelerated aging time
46 days
In weeks
6.5
Aging factor (AAF)
8.00
AAF = Q10(T_AA − T_RT)/10, AAT = real time ÷ AAF, with one month taken as 30.44 days. An estimate for planning; confirm it against ASTM F1980 and your test protocol.
French to millimeters converter
Convert catheter and sheath sizes between French, millimeters and inches.
Type in any box. French size is the outer diameter in thirds of a millimeter: 1 Fr = 0.333 mm, so 9 Fr = 3 mm.
Commonly referenced standards
FDA regulations and guidance
- 21 CFR Part 820, Quality Management System Regulation
- FDA Recognized Consensus Standards database
- Q-Submission Program guidance
- Premarket Notification 510(k)
- The 510(k) Program: Evaluating Substantial Equivalence
Links open the official ISO, ASTM, FDA and eCFR pages.
Let's talk about your device
Tell us where your design stands and what milestone is next. Book a 30-minute intro call, or send a message and we'll reply by email.
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