Medical device testing requirements for 510 (k) submissions

Before a device, especially a medical device sponsor can determine the testing requirement for their device, they must correctly classify their device according to the FDA’s products  Classification database. They must also complete all design and development activities as defined in 21 CFR part 820.30, design control, as any test data submitted in a 510k.

The concept of “product classification” consists of dividing products according to specific characteristics so that they form a structured portfolio.What is product classification?

Classify Your Medical Device

Class I General Controls

  • With Exemptions
  • Without Exemptions

Class II General Controls and Special Controls

  • With Exemptions
  • Without Exemptions

Class III General Controls and Premarket Approval

The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. I

f your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing. All devices classified as exempt are subject to the limitations on exemptions.

Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892.

For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA’s have not been called for. In that case, a 510k will be the route to the market.

Product classification
                                Product classification of medical device

How to Determine Classification

Intended use

Device classification depends on the intended use of the device and also upon indications for use. For example, a scalpel’s intended use is to cut tissue. A subset of intended use arises when a more specialized indication is added in the device’s labeling such as, “for making incisions in the cornea”. 

Indications for use can be found in the device’s labeling, but may also be conveyed orally during sale of the product. A discussion of the meaning of intended use is contained in The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)]

Risk-based

In addition, classification is risk-based, that is, the risk the device poses to the patient and/or the user is a major factor in the class it is assigned. Class I includes devices with the lowest risk and Class III includes those with the greatest risk.

As indicated above all classes of devices as subject to General Controls. General Controls are the baseline requirements of the Food, Drug and Cosmetic (FD&C) Act that apply to all medical devices, Class I, II, and III.

To find the classification of your device, as well as whether any exemptions may exist, you need to find the regulation number that is the classification regulation for your device.

There are two methods for accomplishing this: go directly to the classification database and search for a part of the device name, or, if you know the device panel (medical specialty) to which your device belongs, go directly to the listing for that panel and identify your device and the corresponding regulation. 

If you already know the appropriate panel you can go directly to the CFR and find the classification for your device by reading through the list of classified devices, or if you’re not sure, you can use the keyword directory in the PRODUCT CODE CLASSIFICATION DATABASE.

In most cases this database will identify the classification regulation in the CFR. You can also check the classification regulations below for information on various products and how they are regulated by CDRH.

How to Determine if Your Product is a Medical Device

Device Determination Steps

The following steps may be helpful when trying to determine if a product is regulated by the FDA as a medical device.  

Step 1: Determine if your product meets the definition of a medical device per Section 201(h) of the Food, Drug & Cosmetic Act.

Step 2: Determine if an appropriate product classification exists for your product

Step 1: Determine if your product meets the definition of a medical device

The FDA considers a product to be a device, and subject to FDA regulation, if it meets the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act.

Step 2: Determine if an appropriate product classification exists for your product

Methods

Method 1: Search the Product Classification Database

You may search the FDA Product Classification Database to determine if there is an existing product classification that applies to your product:  

  • Use the Quick Search feature to search by keyword(s). Please note, you may need to conduct multiple searches using a variety of keywords that describe your product (for example, search both “stent” and “stents”). 
  • Use the Advanced Search feature to search by product code, regulation number, or device class.

Method 2: Search for Similar Devices

Search feature:

  • Premarket Approval (PMA) – Most Class III (high risk) devices require Premarket Approval (PMA) before they may be legally marketed. This database includes devices with Premarket Approval, and includes the approval order, Summary of Safety and Effectiveness, and labeling for the approved device (original PMAs and panel-track supplements).

 

  • Premarket Notification 510(k) – Most Class II (moderate risk) devices require 510(k) clearance from the FDA before they may be legally marketed. This database includes releasable 510(k) information.

 

  • De NovoDe Novo provides a possible route to classify novel devices of low to moderate risk. This database includes De Novo classification orders and transparency summaries.

 

  • Humanitarian Device Exemption (HDE) provides is a possible route to market medical devices that may help people with a rare diseases or conditions. This database includes devices with HDE approval, and includes the approval order, Summary of Safety and Probable Benefit, and labeling for the approved device.

Note: Most Class I and some Class II devices may not be listed in the databases referenced above because they are exempt and do not require the FDA’s review before marketing.

Method 3: Search for Similar Devices by Device Listing

You may search for a legally marketed device’s product classification by reviewing its device listing information. Device listing information can be found by searching the FDA’s Establishment Registration and Device Listing database, using either the Quick or Advanced Search feature.

Extracted Performance Standards for Product Code FXX/ medical device
      Extracted Performance Standards for Product Code FXX/ medical device

What to do if your product is not a medical device?

If your product does not meet the definition of a medical device, it may be regulated by another Center within the FDA. If you believe your product is regulated by another Center, you may contact that at Center to discuss the products they regulate.

Center for Biologics Evaluation and Research (CBER)

Regulates biological products.

Center for Drug Evaluation and Research (CDER)

Regulates human drugs.  If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product may be considered a drug.

Center for Veterinary Medicine (CVM)

Regulates products intended for animal use.

Center for Tobacco (CTP)

Regulates tobacco products..

Home-use devices 

Home-use devices present hazardous situations for the layperson. Devices sold Over-the-Counter (OTC) or by prescription are usually self-administered by a layperson in a home setting. A popular example of such a product is a hand-held, light-based laser device to treat full face wrinkles

Vertical vs. horizontal standards 

Two of the most important special controls are the FDA’s Guidance Documents (aka guidelines) and Recognized Consensus Standards (aka performance standards).

 Many FDA guidance documents and performance standards are product code specific (“vertical”) because they apply to a specific type of device (e.g., dental implant; product code DZE). However, other guidance documents and performance standards are not product code specific (“horizontal”) and cover several different types of devices across various Device Classification Panels. 

FDA regulatory information for product code FXX (including Guidance and standards)
     FDA regulatory information for product code FXX (including Guidance and standards)

 

 Recognized Consensus Standards Database Search for a mask/surgical (FXX)
       Recognized Consensus Standards Database Search for a mask/surgical (FXX)

Obtaining FDA clearance through the 510(k) process in the 21st century requires some form of device testing, likely to a known standard. It might also require other types of verification and validation activities related to the device’s design and performance. These critical items prove the safety and efficacy of the device and, in so doing, demonstrate substantial equivalence to the predicate device. 

If you are unable to make a device determination for your product after following the steps above, please contact the Division of Industry and Consumer Education (DICE).

If after reviewing the information provided on this webpage and contacting the Division of Industry and Consumer Education (DICE), you are still unable to make a determination, you may contact the Device Determination mailbox at DeviceDetermination@fda.hhs.gov.

You should include the following information within your Device Determination email request:

  • Intended Use (for example, What is the product supposed to treat or diagnose?)
  • Physical description and mechanism of action
  • Any claims you intend to publicly make about the product
  • Your contact information

If you would like a formal medical device determination or classification from the FDA, consider submitting a 513(g) Request. For instructions on how to submit a 513(g) Request, refer to the guidance document FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act Guidance (2012).

Source: 

Emergo – Whitepaper: Medical device testing requirements for 510 (k) submissions

FDA.gov

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