Free SmartSearch-‘Click here’-See FDA Med Device CFRs ( CFRs 800-898 List)

To Access SmartSearch+ Free, In 2 Steps

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About SmartSearch+

What is SmartSearch+

  • Unique Full-Text (*every word indexed*) US FDA.Gov contents search on ALL FDA Guidance PDF documents & 21 CFR regulations on one screen online for:  Drugs,  Biologics, and Devices (2700 FDA Guidance PDF documents & *94 FDA 21 CFRs*)

  • Works on mobile devices, tablets or laptops with browsers-no app store download, access ALL on one browser screen whether FDA Guidance PDFs or 21 CFRs

  • Full-text search means you are searching  actual published FDA contents inside PDF Guidance  &  contents of  21 CFR statutes not tags or metadata (*27664 total items*)

  • View   search results contents inside PDF Guidance  &  21 CFR  including Subpart, Scope, Section Number and Section Description online –no downloads needed!

It‘s like having FDA.Gov Guidance PDFs & 21 CFRs support staff in YOUR Pocket ! See the video below for proof of concept:

SmartSearch+ allows you to search for medical devices, biologics or drugs as though searching ACTUAL FDA.Gov website databases contents but BETTER!

  • All US FDA CDRH issued Medical Devices PDF Guidance & 21 CFRs (all 34 CFRs on Subchapter ‘H’)
  • All US FDA CDER issued Drugs PDF Guidance & 21 CFRs (all 51 CFRs on Subchapter ‘C’ & ‘D’)
  • All US FDA CBER issued Biologics PDF Guidance & 21 CFRs (all 11 CFRs on Subchapter ‘F’)

SmartSearch+ is now integrated in one app screen with OpenAI’s ChatGPT-3.5 Generative LLM (Large Language Model

FDA gov. search relies on meta data or tags assignment unlike SmartSearch Full-Text

FDA gov. search – if your search keyword doesn’t match FDA tags on summary, topic or Filename columns, You won’t find the PDF document nor 21 CFR status though discoverable (*since published by the FDA!*)

Why the FDA.Gov website search is abysmal – click 3-minute video below:
FDA.Gov Search for Guidance PDFs on devices as biosimilars

FDA.Gov Search Is A Hit or Miss

Zero (0) hits below searching Guidance PDFs on ‘DSCSA’ reference to ‘exemption’

But Finds One (1) hits when searching Guidance PDFs on ‘DSCSA’ reference to ‘dispensers’

US FDA.Gov search relies on metadata (or tags) assignments to match your search keyword – not  full-text contents search like SmartSearch+

Try the same search on FDA’s Database Search website.

🍳 OpenAI ChatGPT-3.5 NLP Chatbot - Sample Prompt/Reply to US FDA Regulations with DSCSA Query

Prompt ChatGPT-3.5 Generative LLM for FDA compliance by repackagers or wholesalers to meet DSCSA regulations ..
..then copy/paste from ChatGPT-3.5 generative reply to send email from the SmartSearch+ app screen in ONE place, no URL hyperlink switching

Click above to learn how SmartSearch+ plus Microsoft Teams Are A Match Made In Heaven

SmartSearch+ paired with YOUR Microsoft Teams are a ‘Match in Heaven’ to boost your FDA regulatory diligence or vigilance within Teams enterprise channels sharing and partners/vendors collaboration with 21 CFRs legal statutes compliance.
Believe it! click to listen why a former US FDA Deputy Director raves about SmartSearch+

Want to learn how you can boost SmartSearch+ productivity in your environment even more ?

Kick up a notch searching FDA then promote search results as Messages Post in your own Teams/channel environment for instant sharing and collaboration.

View Introduction To SmartSearch+ Slides

Learn More what makes SmartSearch+ unique un-matched against even FDA.Gov search with FDA's own contents Believe it!

Introducing US FDA eSTAR, Microsoft Teams and eSTARHelper​

US FDA eSTAR by CDRH
“What is it”? Why bother ?

US FDA launches eSTAR for 510K. De Novo, PMAs & other Premarket Notifications to follow
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Medical Device Regulatory Compliance & Microsoft Teams

Why host YOUR   eSTAR  Premarket 510(K) in Microsoft Teams 

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How eSTARHelper turbo-charges your FDA eStar Premarket Submissions

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Drug Supply Chain Security Act becomes mandatory November 2024. FDA’s DSCSA regulations are no less than a tectonic shift for the entire pharmaceutical drugs industry-are you READY?

DSCSA regulations are COMPLEX! Some apply to all drug undustry stakeholders, others only to certain roles, i.e. only for pharma manufacturers not others

Finding relevant FDA legal regulatory answers when DSCSA regulations is complex and challenging.e.g. what should repacker change with labeling when biiologics container or closure changes

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