FDA Class 1 Medical Device

Picture the last time you reached for a simple adhesive bandage or a manual stethoscope. Although these tools feel ordinary, the U.S. Food and Drug Administration (FDA) still regulates them—just under the lightest level of oversight, known as Class I. In the FDA’s three-tier system, Class I medical devices carry the lowest risk to patients and users, yet they must still meet specific rules to reach (and stay on) the market. 

This guide breaks down everything you need to know about FDA Class I devices—from exemptions and regulatory requirements to labeling and real-world examples—so you can navigate compliance with confidence and get your product in caregivers’ hands faster.

What is an FDA Class 1 Medical Device 

The FDA assigns every medical device to one of three risk-based categories under Section 513 of the Federal Food, Drug, and Cosmetic (FD&C) Act and the implementing regulations in 21 CFR Parts 860–892. Class I represents the lowest-risk tier. A device falls into Class I when “general controls alone are sufficient to provide reasonable assurance of safety and effectiveness” — meaning no special or premarket approval controls are normally required. 

Class I devices share several defining characteristics: 

• Low potential for harm. They are not intended to support or sustain life, nor are they “life-supporting or life-sustaining” as defined in 21 CFR 860.3.  

• Well-established technology. Most Class I products have a long history of safe use and well-understood designs, so broad “general controls” (registration, listing, labeling, quality systems, and adverse-event reporting) are considered adequate.  

• Grouped by generic type. FDA has cataloged more than 1,700 generic device types and organized them into 16 specialty “panels” in 21 CFR Parts 862-892. Each entry specifies the device’s intended use and class designation, allowing manufacturers to match their product to an existing regulation. 

In practical terms, if your product fits the definition of an existing Class I generic type and does not introduce new risks, you will likely follow the most streamlined regulatory path available—subject only to general controls, and often exempt from premarket notification requirements. (Those exemptions and their limits are covered in the next section.) 

FDA Class 1 Medical Device Exemptions 

Even though Class I represents the lowest-risk tier, the FDA still expects manufacturers to follow general controls (registration, listing, labeling, complaint handling, and adverse-event reporting). The good news: many higher-burden rules simply do not apply to most Class I products. 

1. Premarket Notification [510(k)] Exemptions 

• Scope of the exemption. Roughly 74 % of all Class I device types—about 572 generic entries—are exempt from submitting a 510(k) before marketing. fda.gov 

• Legal basis. Exemptions are granted under FD&C Act § 510 (l) and codified in 21 CFR Parts 862-892.  

• Reserved devices & limitations. A small subset labelled “Reserved” still requires a 510(k) because of additional risk factors or novel features. Check the Medical Device Exemptions 510(k) and GMP Requirements database for footnotes and limitations. 

2. Good Manufacturing Practice / Quality System (GMP/QSR) Exemptions 

• Partial or full relief. Many Class I devices are also exempt from the GMP requirements in 21 CFR Part 820, except for § 820.180 (records) and § 820.198 (complaint files), which always apply. 

• How to confirm. Each classification regulation (21 CFR 862-892) states whether design controls or the broader QSR subparts are waived for that specific device type. 

3. How to Verify Your Device’s Exempt Status 

1. Locate the generic type in the CFR or FDA Product Classification database. 
2. Read the exemption note—look for phrases such as “exempt from 510(k)” or “exempt from GMP except §§ 820.180 and 820.198.” 
3. Check footnotes in the exemptions list for any special limitations (e.g., only certain indications qualify). 
4. Document the rationale in your technical file; FDA investigators will expect evidence that you confirmed the exemption. 

4. Obligations That Still Remain 

• Establishment registration (annual) and device listing (21 CFR 807). 

• Correct labeling per 21 CFR Part 801 (covered in a later section). 

• Medical Device Reporting (MDR) for adverse events (21 CFR 803). 

• Corrections and removals reporting, if applicable (21 CFR 806). 

Understanding these exemptions lets manufacturers streamline time-to-market without overlooking the baseline controls FDA still enforces. In the next section, we’ll map out every general control that does apply to Class I devices—and how to satisfy them efficiently. 

Regulatory Requirements for a Class I Medical Device 

Under the FD&C Act and Title 21 of the Code of Federal Regulations (CFR), Class I devices must still meet “general controls” even when many are exempt from 510(k) and most of Part 820. The essentials are outlined below, with the governing CFR parts and FDA links for deeper reference. 

Core Requirement	Key CFR Part(s)	What You Must Do	Notes for Class I Devices
Establishment Registration & Device Listing	21 CFR 807 Subparts B–E	Register your facility with FDA and list every device you commercially distribute; verify or update each year between Oct 1 – Dec 31.	Applies to all Class I firms—no exemption.
Quality System Regulation (QSR)	21 CFR 820	Follow good manufacturing practice. Most Class I devices are exempt from design controls and other subparts, but records (§ 820.180) and complaint files (§ 820.198) always apply.	Check your device’s specific entry in 21 CFR 862–892 to confirm the exact scope.
General & UDI Labeling	21 CFR 801; 21 CFR 830	Provide an accurate label that includes manufacturer info, intended use, and any required warnings. As of Sept 24 2023, Class I devices must also bear a Unique Device Identifier (UDI) unless specifically excepted.	OTC instructions, IFU, and language requirements still apply.
Medical Device Reporting (MDR)	21 CFR 803	Submit a report within 30 calendar days of learning your device may have caused or contributed to a serious injury, or immediately if a death has occurred.	Importers and user facilities have parallel duties; voluntary reporting remains encouraged.
Corrections & Removals	21 CFR 806	Notify FDA within 10 working days if you initiate a field correction or removal to reduce a risk to health or remedy a legal violation.	Not required if the action is solely a market-quality enhancement or already reported under MDR.

Practical tips for Class I manufacturers 

1. Document your exemptions. Keep a copy of the CFR section showing any 510(k) or GMP waiver in your technical file—investigators will ask. 
2. Leverage electronic systems. Digital complaint logs, CAPA workflows, and automated UDI generation simplify record-keeping and audit readiness. 
3. Monitor guidance updates. FDA periodically revises QSR (e.g., the QMSR final rule aligning with ISO 13485) and UDI enforcement timelines. Staying current avoids surprise gaps. 

Meeting these general controls is the price of market entry—skip them and FDA can detain imports, issue warning letters, or mandate recalls even for low-risk devices. In the next section, we’ll walk through the streamlined approval pathway (or lack thereof) most Class I products enjoy and the small subset that still require a 510(k). 

Approval Process of Class 1 Medical Devices 

The word “approval” is a misnomer for most Class I products—what the FDA requires is either simple listing (for the 510(k)-exempt majority) or a streamlined premarket notification [510(k)] for the small group of “Reserved” devices.
   

Regulatory Pathway	Who Must Follow It	Core Steps (in order)	Statutory / Typical Timeline	Endpoint
Exempt Listing (≈ 93 % of Class I devices)	Any device whose regulation in 21 CFR Parts 862-892 states “510(k) exempt.”	1. Establishment Registration in FDA Unified Registration & Listing System (FURLS). 2. Device Listing—identify the product code and regulation number. 3. Implement required general controls (records, labeling, MDR, etc.).	Registration & listing must be completed before commercial distribution; update annually (Oct 1 – Dec 31).	Device may be marketed immediately once listing is active.
510(k) Clearance (“Reserved” Class I devices—≈ 50 types)	Products specifically marked “Reserved” in their CFR entry or that exceed exemption limits (e.g., novel indications).	1. Confirm “Reserved” status in Medical Device Exemptions 510(k) & GMP database.  2. Prepare an electronic 510(k) using the eSTAR template (mandatory for submissions after Oct 1 2023).  3. Pay user fee (discounted small-business rate if qualified). 4. Submit via CDRH Portal or ESG. 5. FDA Acceptance Review (≤ 15 days) → Substantive Review (goal 60 days) → Final decision (statutory 90 days).	~90 FDA days (clock pauses for Additional Information requests).	FDA issues a 510(k) clearance letter; firm can then list and market.

Key Details & Best Practices 

• Verify status early. Use the Product Classification database to cross-check your product code, regulation number, and whether it is 510(k)-exempt or Reserved.  
• No 510(k) ≠ no oversight. Even exempt devices must register, list, comply with labeling (UDI included), maintain complaint files, and submit MDRs where required. 
• When exemptions don’t apply. A device loses its exemption if it: 
• • Is intended for a use different from the identified generic type; 

• • Operates using novel technology raising new safety/effectiveness questions; or 

• • Is combined with a drug or biologic constituent. In these cases, FDA may require a 510(k) or even a De Novo request.  
• Leverage eSTAR. FDA’s structured PDF template automates completeness checks and speeds the technical screening phase—most “Refuse to Accept” issues are avoided when eSTAR is used. 
• Keep an “administrative file.” Whether exempt or not, maintain proof of registration/listing, your 510(k) clearance (if applicable), and rationale for exemption; inspectors regularly request this documentation. 

With the pathway confirmed, the next compliance hurdle is labeling—and even Class I devices face detailed rules there. The following section drills into Part 801 and UDI obligations you must meet before shipping product. 

Labeling Requirements for Class I Medical Devices 

Even the lowest-risk devices can be pulled from the market if the label is wrong. FDA treats mislabeling as misbranding under Sections 502(a) and 502(f) of the FD&C Act, so every Class I firm must follow the device-labeling framework in 21 CFR Part 801 and, for unique device identifiers, 21 CFR Part 830. 

1. Mandatory Elements on the Principal Display Panel 

• Statement of identity – the common/usual name or an established descriptive term. 

• Manufacturer name and business address – must be the party that initially labels the device for commercial distribution (subsidiary addresses alone are not sufficient). 

• Intended use / indications – clear enough that the average clinician can grasp who, what, and when the device is for; avoid implied claims that move the product into Class II or III. 

• Adequate directions for use (§ 801.5) – step-by-step instructions, preparation, and any special handling; “Rx Only” products can rely on professional disclosure, but most Class I devices are OTC and must spell this out. 

• Warnings, cautions, contraindications – e.g., latex allergy statement (§ 801.437) if natural rubber is present. 

• Lot, batch, or serial number – enables traceability for complaint investigation; strongly encouraged even when not explicitly mandated by QSR exemptions. 

Tip: Keep wording and fonts legible at the point of use; Part 801 does not dictate font size, but inspectors cite firms when small or glossy text is unreadable. 

2. Unique Device Identifier (UDI) Obligations 

Deadline met: All Class I device labels and packages produced on or after Sept 24 2023 must carry a UDI and be listed in the Global UDI Database (GUDID), unless a specific exception or alternative applies.  

• UDI structure – two segments: 

• Device Identifier (DI): fixed, identifies the labeler and model/version. 

• Production Identifier (PI): variable, may include lot, serial, expiry, etc. 

• Direct marking – reusable Class I devices intended to be reprocessed between uses must bear a permanent UDI on the device itself (§ 801.45). 

• Consumer-health exceptions – certain low-risk retail items (e.g., elastic bandages) may defer GUDID submission under the consumer health product policy, but the label still needs a scannable UDI.  
• Legacy numbers (NDC/NHRIC) retired – FDA ended the grace period; those codes cannot appear on devices labeled after Sept 24 2023.  

3. Special-Situation Labeling in Part 801 

Scenario	Key Section	What to Include	Notes
In-process sterile goods shipped to contract sterilizer	§ 801.150(e)	Prominent “Unsterilized—For Sterilization Only” statement; agreement on handling	Prevents unsterile product from reaching users. fda.gov
OTC devices sold retail	§ 801.61–801.62	Net quantity, retail-oriented instructions, and any graphics needed for lay users	Must be understandable by non-professionals.
Prescription-only Class I devices (rare)	§ 801.109	“Rx Only” legend in a box or standout type	Directions for professional use may be supplied separately.

4. Electronic Instructions for Use (e-IFU) 

FDA permits e-IFU only for specific hospital-use devices or under enforcement discretion. Class I manufacturers should assume a paper IFU is required unless qualifying under a declared electronic-labeling guidance. 

5. Record-Keeping & Change Control 

• Retain copies of every label version for two years after the device’s last production lot (§ 820.180) even if your device is otherwise QSR-exempt. 

• Use a formal change-control procedure—label revisions that omit a UDI character or alter indications can trigger recalls or MDR events. 

6. Common Pitfalls Cited in FDA 483s 

1. Omitted manufacturer address on private-label products. 
2. UDI barcode too small or low-contrast for scanners. 
3. Outdated cautionary language left on artwork after a design tweak. 
4. Failure to update GUDID after DI changes or company name changes. 

A Class I label may look simple, but every line is governed by Parts 801 and 830. Treat label creation like any other controlled process—verify elements, affix a compliant UDI, retain proof, and you’ll avoid the misbranding trap. Next, we’ll anchor these requirements with concrete product examples to show how they apply in the real world. 

Examples of FDA Class 1 medical device 

Below are three concrete examples straight from an FDA device-classification briefing. Together they illustrate how wide-ranging—and generally low-risk—Class I products can be.  

• Elastic bandages – Common first-aid wraps used for compression or minor support. Their simple, non-powered design poses minimal risk, so general controls (labeling, complaint files, MDR) are considered sufficient. 

• Hand-held manual surgical instruments – Think scalpels, forceps, clip appliers, or biopsy brushes. Because they are non-powered, reusable, or disposable, and already have a long history of safe clinical use, they remain in Class I unless modified in ways that introduce new hazards. 

• Differential culture media – Prepared nutrient formulations that help laboratories distinguish between bacterial species. While used in diagnostic workflows, these media neither sustain life nor directly treat patients, keeping their risk profile and classification low. 

These examples underscore the diversity of Class I devices: everyday wound-care supplies, basic surgical tools, and even routine lab reagents can all share the same low-risk regulatory tier when general controls alone assure safety and effectiveness. 

How Qualityze Can Help with Class I Medical Device Compliance and Regulations

The FDA makes it clear: even the lowest-risk devices must comply with general controls—registration, listing, labeling, complaint files, records, and (when applicable) good manufacturing practices. Qualityze’s cloud-native EQMS automates those touch-points so you can meet every item in 21 CFR without drowning in spreadsheets.  

1. Establishment Registration & Device Listing

• • Automated reminders alert you when the annual Oct 1–Dec 31 renewal window opens. 

• • Pre-configured forms capture the exact data fields FDA’s FURLS portal requires, minimizing re-keying errors. 

• • Versioned evidence packs store registration certificates and device-listing confirmations for auditor review.  

2. Labeling & Misbranding Protection

• • A controlled artwork library enforces approval workflows, so every label bears the correct identity statement, manufacturer address, directions for use, and UDI. 

• • Electronic change-control links label revisions to risk assessments, preventing untracked edits that could trigger misbranding findings. 

3. Complaint Handling & MDR Readiness

• • Centralized intake captures complaints, flags potential reportable events, and drives 30-day MDR timelines with dashboards. 

• • Built-in decision trees mirror FDA MDR criteria, ensuring “caused or contributed” logic is applied consistently.  

4. Records & Reports Per § 519

• • Secure record modules retain device history files, traceability logs, and service records—searchable and locked against alteration for the life of the product plus archive years. 

• • Configurable retention rules guarantee you can produce any record FDA might request under Section 519 authority. 

5. Quality System Elements That Always Apply

• • Even when most of Part 820 is exempt, § 820.180 (records) and § 820.198 (complaint files) remain. Qualityze delivers both out of the box, with electronic signatures and full audit trails aligned to current GMP principles.  

6. Corrective Actions & Field Notifications

• • If you must repair, replace, or refund under Section 518, Qualityze CAPA system ties corrective actions to affected lots and auto-generates customer-notification lists, streamlining recall-class determinations.  

7. Real-Time Compliance Intelligence

• • Role-based dashboards consolidate KPIs—open complaints, impending registration renewals, label change status—giving executives a single view of FDA compliance health. 

• • Audit-ready reports export in seconds, so investigators spend less time waiting and more time closing inspections. 

General controls may be lighter than a PMA, but they are still far-reaching. Qualityze EQMS Suite weaves each requirement from the FDA’s General Controls for Medical Devices into an integrated, traceable workflow—helping Class I manufacturers stay market-ready without excessive administrative overhead. 

See it in action by requesting a free demo.