EMC China Lab

Do Class I Medical Devices Need a 510(k)?

Views :
Update time : 2024-07-27

Manufacturers aiming to market Class II medical devices (and some Class I and III devices) or in vitro diagnostic devices (IVD) in the United States must submit a 510(k) premarket notification to the FDA. Most Class I and some Class II products can directly undergo company and product registration without submitting safety and effectiveness reports to the FDA.

 

Do Class I Medical Devices Need a 510(k)?(图1)


Device Classification

The FDA has classified over 1,700 unique types of medical devices, which are listed in 16 categories (or panels) within the Code of Federal Regulations (CFR). Determining whether your device is a Class I, II, or III medical device begins with identifying the relevant panel.

 

What is a Class I Medical Device?

Class I medical devices have minimal contact with patients and minimal impact on their overall health. These devices typically do not interact with internal organs, the circulatory system, or the central nervous system. Approximately 47% of medical devices are Class I, and about 95% of these are not subject to regulatory processes.

 

If a medical device is considered exempt, it does not require a 510(k) premarket notification or premarket approval (PMA) before being sold in the United States. However, manufacturers must register their facilities and products with the FDA. They must also comply with the general control measures applicable to all classes of medical devices, including those for adulteration, misbranding, device registration, record-keeping, and good manufacturing practices.

 

Examples of Class I Medical Devices

- Enema kits

- Stethoscopes

- Latex gloves

- Bandages

- Bedpans

- Tongue depressors

- Surgical masks

- Irrigating dental syringes

 

What is a 510(k)?

A 510(k) refers to a premarket notification process mandated by Section 510(k) of the Federal Food, Drug, and Cosmetic Act. Applicants must submit a safety and effectiveness report to the FDA, demonstrating that the device is substantially equivalent to a legally marketed predicate device. If approved, the applicant receives a 510(k) number, signifying that the device is as safe and effective as the predicate device.

 

Determining Your Medical Device Classification

The FDA has categorized over 1,700 unique medical devices into groups within the Electronic Code of Federal Regulations (eCFR). Identifying your device's category within these groups is the first step in determining whether it is a Class I, II, or III device. The 16 panels are:

 

- Anesthesiology

- Cardiovascular

- Chemistry

- Dental

- Ear, Nose, and Throat

- Gastroenterology and Urology

- General and Plastic Surgery

- General Hospital

- Hematology

- Immunology

- Microbiology

- Neurology

- Obstetrics and Gynecology

- Ophthalmic

- Orthopedic

- Pathology

- Physical Medicine

- Radiology

- Toxicology

 

To classify your medical device, start by selecting the appropriate panel. For example, to classify a blood pressure cuff, select the cardiovascular panel, then choose "blood pressure cuff" under cardiovascular diagnostic devices. The classification page will indicate that blood pressure cuffs are Class II devices based on performance standards.

 

510(k) Submission Requirements

A typical 510(k) submission includes:

 

1. Cover letter and table of contents (including attachments)

2. Truthfulness declaration (using FDA's standard template)

3. Registration number (or a statement if not yet registered)

4. 510(k) summary or statement

5. Product information:

   - Device name

   - Classification

   - Performance standards

   - Product identification

6. Substantial equivalence comparison (SE)

7. Device description:

   - Intended use

   - Operating principle

   - Power source

   - Components

   - Photos

   - Process diagrams

   - Assembly drawings

   - Structural diagrams

8. Safety and effectiveness information:

   - Design and testing data

9. Biocompatibility information

10. Color additive information (if applicable)

11. Software validation (if applicable)

12. Sterilization information (if applicable):

   - Sterilization method

   - Validation

   - Product packaging

   - Labeling

 

Note: Inapplicable items can be omitted. For instance, passive devices do not need software technical files or software test results, and most mature products do not need clinical trial results.

 

Specific Advantageous Services

1. Annual registration and product listing on the FDA website:

   - Product premarket approval (510(k), exempt 510(k))

   - Maintaining active status of company accounts

2. Dun & Bradstreet number query and activation

3. Product classification and code matching

4. Application for creating FDA UDI-DI and GUDID accounts

5. GUDID database entry of critical device information

6. FDA standard testing

 

By understanding these processes and requirements, manufacturers can ensure compliance and facilitate the successful market entry of their medical devices in the United States.


Email:hello@jjrlab.com


Leave Your Message


Write your message here and send it to us


Related News
Read More >>
Electric Kettle RoHS Testing Electric Kettle RoHS Testing
04 .06.2025
Electric kettle RoHS testing is essential for export. China JJR Lab offers fast, reliable RoHS testi...
Display RoHS Testing Display RoHS Testing
04 .06.2025
Display RoHS testing ensures EU compliance by limiting hazardous substances. Testing starts at $450....
electric blanket rohs testing electric blanket rohs testing
04 .06.2025
Electric blanket RoHS & CE testing for EU market compliance. China JJR Laboratory provides certi...
ISO 10993-5 Tests for In Vitro Cytotoxicity ISO 10993-5 Tests for In Vitro Cytotoxicity
04 .03.2025
ISO 10993-5 in vitro cytotoxicity testing evaluates the toxicity of medical devices and biomaterials...
FDA Designated Cytotoxicity Testing Laboratory FDA Designated Cytotoxicity Testing Laboratory
04 .03.2025
FDA-designated cytotoxicity testing lab, JJR China, offers FDA-compliant biocompatibility testing wi...
Cytotoxicity Testing Labs Cytotoxicity Testing Labs
04 .03.2025
Cytotoxicity testing ensures medical device safety. JJR Lab provides compliant certification, meetin...
Introduction to UL94 Flammability Testing Introduction to UL94 Flammability Testing
04 .03.2025
UL94 is a key plastic flammability test for safety and compliance in electronics, automotive, and mo...
Canada Electrical Product Compliance Certification Canada Electrical Product Compliance Certification
04 .03.2025
JJR Lab tests electrical products for compliance with Canadian standards (CSA C22.2/UL), ensuring th...

Leave Your Message