Your personal guide to FDA regulations
FDA rules, explained like a call with a colleague.
Meet Fredda, your friendly AI expert* for FDA regulations and clinical trials. Call or text your question and get a clear, plain-language answer, plus a summary of the whole conversation.
- ✓ 24/7 availability
- ✓ Natural voice or text conversations
- ✓ Actionable summaries
FreddaHelp is not an official FDA-affiliated resource. It is meant to guide you in the right direction. For legal regulatory actions, always seek professional advice, including from the FDA.
Try a question
Pick what's on your desk today.
Sample answers show the format: plain language first, then the regulation, then where to go next.
YOU ASK
“What is a 510(k)?”
FREDDA ANSWERS
A premarket notification that shows your device is substantially equivalent to a legally marketed predicate device. Fredda helps you understand how predicates are chosen and what FDA expects the submission to cover.
SOURCE
21 CFR Part 807, Subpart E
Premarket notification procedures.
ASK NEXT
YOU ASK
“When does my study need an IND?”
FREDDA ANSWERS
Generally when you plan to test an unapproved drug or biologic in people, or study a new use of an approved one. Some studies can qualify for an exemption, and Fredda helps you check the criteria before you talk to FDA.
SOURCE
21 CFR Part 312
Investigational new drug application.
ASK NEXT
YOU ASK
“What has to be on a medical device label?”
FREDDA ANSWERS
General labeling rules cover items like the name and place of business of the manufacturer, packer or distributor, and adequate directions for use, plus a unique device identifier where it applies. Fredda points you to the sections that fit your device.
SOURCE
21 CFR Part 801
Labeling requirements for devices.
ASK NEXT
YOU ASK
“Do our e-signatures meet Part 11?”
FREDDA ANSWERS
Part 11 sets the criteria for electronic records and signatures to be trusted like paper: controls such as audit trails, limited system access and signature manifestations. Fredda turns it into a checklist you can review with your QA team.
SOURCE
21 CFR Part 11
Electronic records; electronic signatures.
ASK NEXT
What is FreddaHelp?
A regulatory guide you can actually call.
Fredda is an AI-powered assistant designed to navigate the complexities of FDA regulations and clinical trial inquiries. With access to curated databases and up-to-date information, Fredda gives you clear guidance on compliance, regulatory processes and best practices in the medical field, whether you're checking FDA guidelines or working through a clinical trial protocol.
Instant support
Press a button and talk to Fredda, like calling a friend or consulting an expert. Real-time answers, day or night.
Natural conversations
Ask the way you would ask a colleague, by voice or text, and follow up as much as you need.
Conversation tracking and summaries
Every question and answer, calls included, saved as a clear summary you can come back to.
Comprehensive database knowledge
Draws on FDA-curated databases such as openFDA, MAUDE and Drugs@FDA.
Ask out loud
Call or type your question about FDA rules, submissions or your clinical trial.
Get the why
Fredda answers in plain language and points you to the regulation, guidance or FDA database behind it.
Keep the summary
Your conversation is saved as a summary, ready to revisit or share with your team or advisor.
Who uses it
Built for the people who own the submission.
REGULATORY AFFAIRS
Sanity-check before you draft
Confirm which pathway and which sections apply before you spend a week on the wrong one.
CLINICAL RESEARCH
Answers between site visits
Informed consent, IRB and recordkeeping questions answered while you are on the move.
FOUNDERS
Speak FDA fluently
Get oriented on what a submission involves before you hire consultants or meet investors.
Pricing
Simple, straightforward pricing.
Try it out for free or pick the plan that fits how often you ask.
PRO PLAN
POPULAR$15 / month
- 50 questions per day
- Follow-up queries
- Comprehensive summary
- Store or delete history
ULTIMATE PLAN
$30 / month
- Unlimited questions
- Follow-up queries
- Comprehensive summary
- Store or delete history
- FreddaHelp flexible support
Prices in US dollars.
News & guides
All newsNews & guides
First articles coming soon.
We're writing plain-language guides to FDA submissions, clinical-trial rules and recordkeeping. Until they're up, Fredda can answer your question right now.
Fredda in your pocket. Ask from the lab, the plant or the airport.
24/7 availability · Instant response without waiting · Comprehensive assistant · Natural voice or text conversations · Accurate regulatory information · Tailored responses · Actionable summaries.
Right here in your browserTalk to Fredda