US FDA Medical Device Classification and Determination 101

This article gives you a high-level, 3-step overview of the process for making a US FDA medical device classification. Handy links to applicable regulations and guidance documents are included to help you navigate the FDA classification process.

To begin, determine if your product meets the FDA’s definition of a medical device, drug, cosmetic, or biologic. This will help identify which regulations are applicable.

The first step to determine your product’s regulation is to compare the intended use, labeling, and claims to the definitions found in the regulations. Labeling and claims include any written or pictorial images that accompany your product or are included in website pages and/or other forms of advertisement. Compare them to the definitions provided in the regulations:

• Medical Device: Section 201(h) of the FD&C Act
• Drug: Section 201(g) of the FD&C Act
• Cosmetic: Section 201(i) of the FD&C Act
• Biologic: Section 351 of the Public Health Service (PHS) Act

FDA Guidance: FDA issued a Guidance Document which details the classification process focusing on the differences between drugs and devices.

For this example, we determined the product meets the definition of a medical device. The next step is to classify your medical device by identifying which product code applies.

To determine classification, access the FDA’s classification database to research device names and associated product codes and the classification designated under the Code of Federal Regulation (CFR). The product codes are groupings designated by FDA based on intended use. The CFRs designated under 21 CFR Parts 862 – 892 further describe the device and state if special controls are required.

• FDA Classification Database
• FDA Database CFR Title 21

Researching Competitor Devices: Locate similar competitor devices that are cleared by 510(k) or approved by PMA or De Novo decisions search the following FDA databases.

• FDA 510(k) database
• FDA PMA database
• DE Novo-database

Exploring Alternative Paths: If aware of a competitor product but unable to locate the regulatory path in the above databases look to the Registration and Device Listings database to see what product code the competitor is listing the comparable device under.

• FDA Establishment Registration & Device Listings

If the device determination is still unclear, or a good match in product code is not found, you can consider asking FDA.

Informal Feedback: There are two ways to ask FDA for feedback on a device determination or classification question; email CDRH for an informal determination or the take the formal 513(g) approach. FDA has made available a couple Guidance Documents which describes the 513(g) process and associated user fees.

Informal process for simple questions:

• No User Fees
• Email necessary information to CDRH device determination mailbox at DeviceDetermination@fda.hhs.gov
• Typically, a 15-day response time

Formal Approach: The types of questions that FDA will accept via the 513(g) process are those related to device determination, classification, and regulatory pathway. Questions that are not suitable for the 513(g) process are those on performance-data requirements or reclassification. These are best suited for the FDA’s Q-Sub process.

Guidance Documents: Understanding the Process and Fees: 513(g) Determination Request for complex questions:

• Send User Fees to CDRH (FY2024 MDUFA standard Fee is $6,528)
• FDA Form 3601 Medical Device User Fee Cover Sheet
• Prepare information packet per 513(g) Guidance Document
• eStar submission is voluntary
• eCopy requirements required
• Typically, a 60-day response time
• FDA issues a formal letter with recommendation on classification and pathway, or an indication the device falls under enforcement discretion.

Celegence can assist you in device type determination, classification, regulatory pathway, and identification of which regulations apply. We offer regulatory subject matter experts experienced in various therapeutic areas including Anesthesiology, Cardiovascular, Dental, Gastroenterology and Urology, General and Plastic Surgery, Ophthalmic, Orthopedic and Radiology with over 30+ years’ experience in regulatory affairs. Celegence can provide support for your project including a complete regulatory strategy or custom fit your needs with a few select or all the items listed below:

• Determine product type; medical device, cosmetic, drug, biologic, or combination product.
• Choosing the appropriate FDA Product Code and applicable CFR(s).
• Identify regulatory pathway; Exempt, 510(k), PMA, De Novo, HUD, EUA, BLA, NDA, IDE, etc.
• If a combination product; prepare and submit a Request for Designation (RFI).
• If device but unclear, prepare and submit a 513(g) submission to CDRH.
• Identify applicable regulations and associated guidance documents.
• Prepare and submit 510(k), PMA, De Novo, HUD, EUA, BLA, NDA, ANDA, RFI, and IDE, submissions.
• Prepare, submit, and conduct FDA Q-Sub meetings.

Celegence, led by Sonia Veluchamy is more than a regulatory consulting firm. We are a strategic partner specializing in both medical devices and pharmaceutical submissions. Celegence provides regulatory strategy consulting and can help you navigate the complexities of FDA guidance interpretation and FDA interactions. If you need any assistance with FDA submissions, then reach out to us at info@celegence.com or contact us online for more information.