Who We Serve: Device Class
Class I Device Manufacturers
Class I devices carry the lowest risk, and many of them are exempt from premarket notification. That is often read as exempt from the quality system altogether, which it usually is not. We help Class I manufacturers confirm what actually applies to their device and put the records inspectors still ask for in order.
Standards and Regulations to Know
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- 21 CFR Part 807Establishment Registration, Device Listing and Premarket Notification (510(k))
- 21 CFR Part 803Medical Device Reporting
- 21 CFR Part 806Reports of Corrections and Removals
- 21 CFR Part 830Unique Device Identification
- ISO 13485Quality Management Systems for Medical Devices
Typical Regulatory Exposure
Class I devices are subject to FDA's general controls, including establishment registration and device listing, labeling, medical device reporting, corrections and removals reporting, and the Quality Management System Regulation in 21 CFR Part 820, which incorporates ISO 13485:2016 by reference. Many Class I devices are exempt from premarket notification, and some are exempt from most quality system requirements, though records and complaint handling requirements typically still apply.
Exemptions are device-specific. They are listed in the classification regulation for each device type, and they come with limitations: a new intended use, a different technology or a change in how the device works can take a product outside its exemption. The right starting point is the classification regulation itself, read against your current labeling and design, not a summary someone wrote years ago.
Class I firms are still inspected. When FDA arrives, investigators work through the areas of Compliance Program 7382.850 that apply to you, and a firm that treated its exemption as a blanket pass often has thin complaint files, no documented reportability decisions and no record of how product changes were reviewed.
Where Audits Find Gaps
- 01
Exemption Scope Never Documented
Nobody can show which classification regulation the device falls under, what the exemption covers, or why recent changes did not take the device out of scope. An investigator may ask, and the answer should already be on paper.
- 02
Complaints Kept as Customer Service Tickets
Complaints sit in a shared inbox or a help desk tool, with no evaluation of whether each one could be a reportable event and no record of the investigation decision.
- 03
No Documented Reportability Decisions
Even when nothing has been reported to FDA, there should be a record showing each complaint was assessed against the medical device reporting criteria in 21 CFR Part 803.
- 04
Changes Made Without Review
Material, supplier or labeling changes go straight into production. Without a change record, there is no way to show the change was evaluated for its effect on the device or on its exemption.
- 05
Registration and Listing Out of Date
Products added, discontinued or renamed since the last annual registration are not reflected in the device listing.
- 06
Procedures Written for a Larger Company
A template QMS bought off the shelf describes processes the firm does not run, which turns every unfollowed procedure into a potential observation.
Relevant Standards and Regulations
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- 21 CFR Part 807Establishment Registration, Device Listing and Premarket Notification (510(k))
- 21 CFR Part 803Medical Device Reporting
- 21 CFR Part 806Reports of Corrections and Removals
- 21 CFR Part 830Unique Device Identification
- ISO 13485Quality Management Systems for Medical Devices
Relevant Services
Full Audit Readiness Assessment
Documents, records, evidence and interviews, checked against the specific audit you're facing next.
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
QMSR Transition
Bringing a QSR-era or ISO 13485 quality system in line with FDA's QMSR, which is now in effect.
Audits and Inspections You May Face
Questions
If my Class I device is exempt from 510(k), is it exempt from the QMSR too?
Not necessarily. Exemption from premarket notification and exemption from quality system requirements are separate, and both are defined device by device in the classification regulation. Even where most quality system requirements are exempted, records and complaint handling requirements typically still apply.
Does FDA actually inspect Class I manufacturers?
Yes. Class I firms are registered establishments and can receive routine or for-cause inspections. Complaints, reports to FDA or a recall can each lead to a visit.
What should a small Class I firm fix first?
Start with complaint handling and reportability decisions, since those requirements reach most Class I firms and are easy for an investigator to sample. Then document your exemption basis and bring your change records up to date.
Can you review a QMS we bought as a template?
Yes. Upload the procedures as they are, in whatever format you have. The AI-assisted first pass compares what the procedures say against the records you actually keep, and an advisor decides which procedures to simplify, keep or retire.
Class I Device Manufacturers
Get an Advisor's View of Your Quality System
Tell us about your devices and the audit or inspection ahead, and an advisor will scope an assessment for your kind of product. Please don't send confidential documents yet: secure upload is set up after onboarding.
