How Much Does It Cost to Register a Medical Device with the FDA in 2027? 

The FDA charges fees for almost all of its activities. FDA fees for your device registration will depend on the device classification and can vary considerably. However, if you are considered a small business by the FDA, you may be eligible for reduced fees on regulatory submissions.  

At MedEnvoy Global, we have represented over 10,000 medical devices and have been working directly with the FDA for decades. Our experience gives us a thorough understanding of the shifting and complex fee structure for bringing a medical device to market, and we offer end-to-end support throughout the process for foreign and domestic establishments. 

If you want an assessment of how much you might owe, as well as assistance applying for cost-reduction opportunities, contact our FDA regulatory specialists today.  

Annual Establishment Registration Fee for 2027 

The numbers below reflect official FY 2027 Medical Device User Fee Amendments (MDUFA) user fees, which change annually on October 1 of each year. Also note that the Establishment Registration Fee is an annual recurring cost and is not eligible for the standard Small Business reduction. However, small businesses can save significantly on certain application fees. 

For 2027, the annual establishment registration fee is $13,785.  

Most establishments are required to pay this fee every year, as well as additional fees depending on your device’s classification.  

Other required fees for medical devices include: 

510(k) exempt (Mostly Class I, some Class II): 

● Application Fee: $0 (Exempt) 

● Establishment Registration: $13,785 

● Total Standard Fees: $13,785 

● Total Small Business Fees: $13,785  

510(k) (Mostly Class II, some Class I and Class III):  

● 510(k) Application Fee: $28,653 (Standard 510(k)) or $7,163 (Small Business) 

● Establishment Registration: $13,785 (this fee is not due at the time of the 510(k) submission) 

● Total Standard Fees: $42,438 

● Total Small Business Fees: $20,948 

Premarket Approval (Class III): 

● PMA Application Fee: $636,732 (Standard) or $159,183 (Small Business) or $0 (small business, one-time fee waiver) 

● Establishment Registration: $13,785 (this fee is not due at the time of the PMA submission) 

● Total Standard Fees: $650,517* 

● Total Small Business Fees: $172,968* 

*Once approved, keeping a Class III device on the market requires paying an Annual Periodic Reporting Fee of $22,286 ($5,572 for small businesses) on top of your annual $13,785 Establishment Registration fee. 

De Novo Classification: 

● PMA Application Fee: $191,000 (Standard) or $47,755 (Small Business) 

● Establishment Registration: $13,785 however, this fee is not due at the time of the De Novo submission 

● Total Standard Fees: $204,785 

● Total Small Business Fees: $61,540 

These fees don’t include any testing or clinical trial costs required for your device. FDA fees make up only a portion of your overall go-to-market budget, especially if you are marketing a Class II or III device that requires extensive testing or human trials. 

Who Has to Pay The Annual Fee? 

If your establishment is involved with the distribution and production of medical devices to be commercially distributed in the United States, you must register annually with the FDA. With annual registration comes annual fees.  

The following types of domestic establishments are expected to pay the annual fee: 

• Contract manufacturers, including contract packagers 

• Contract sterilizers 

• Any establishment located in a foreign trade zone involved with the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for commercial distribution in the United States 

• Initial importers 

• Establishments that maintain complaint files as requested under 21 CFR 820.198 

• Manufacturers of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user 

• Manufacturers, including kit assemblers 

• Manufacturers of custom devices 

• Relabelers 

• Repackagers 

• Reprocessors of single-use devices 

• Specification developers 

• US-based manufacturers of export-only devices 

The following types of foreign establishments are expected to pay the annual fee: 

• Contract manufacturers, including contract packagers 

• Contract sterilizers 

• Custom device manufacturers 

• Foreign exporters of devices located in a foreign country 

• Foreign manufacturers 

• Establishments that maintain complaint files as required under 21 CFR 820.198 

• Manufacturers of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user 

• Relabeler 

• Repackager 

• Remanufacturer 

• Reprocessors of single-use devices 

• Specification developers 

Visit this page for a complete breakdown of which establishments must register and pay fees. 

Standard Fee VS Small Business Fee 

If you want to pay the small business fees instead of the standard fees, the FDA needs to approve your status as a small business. Do not submit your application until the FDA has sent an official Small Business Determination approval. To do so, you’ll need to go through the Small Business Determination (SBD) program.  

This determination makes a significant difference in your FDA fees. For example, the standard fee for a PMA submission is over $650,000, but if you qualify for a small business, that could drop it down to under $172,968. That’s a decrease of nearly 75%. 

Whether you qualify depends on what benefit your establishment is seeking. Since the program is divided into three tiers, you will need to prove that the gross sales or receipts of your establishment and affiliates are less than $100 million, $30 million, or $1 million.  

The $1 million tier has the strongest benefits, including a registration fee waiver, tax credits, and some baseline exemptions. For businesses with sales under $30 million, they qualify for a “first premarket application/report” fee waiver. Businesses with sales under $100 million qualify for the reduced small business fee in certain submissions. 

Applying for this program involves submitting tax returns and completing the 3602N form. At MedEnvoy Global, we can determine if you qualify for the SBD program and walk you through the process of applying. 

Ways to Save Money on FDA Medical Device Registration 

In addition to the SBD program, there are other ways to reduce fees when registering medical devices with the FDA. We can help you determine how these might apply to your establishment: 

• First-time waiver – If your establishment qualifies for the $30 million or less tier, you can qualify for a one-time waiver for your very first premarket approval (PMA), portmarketing requirement (PMR), or biologics license application (BLA) submission. 

• Hardship waiver – If your establishment qualifies for the $1 million or less tier, and you have paid the annual establishment registration fee in a prior fiscal year, and you are facing a financial hardship (such as bankruptcy), the FDA could waive the establishment registration fee. 

Some budget best practices that can help avoid unnecessary fees and penalties include: 

• Confirming the timing – Don’t jump the gun on paying for the registration fee. Ensure that your product is cleared before you pay a fee for a product that cannot be sold yet. 

• Meeting the deadline – You must pay the registration fee between the window of October 1 and December 31. There is no financial penalty if you miss this window, but your registration becomes inactive and your product cannot legally be sold.  

How Can MedEnvoy Global Help 

Navigating the fee structure of the FDA medical device system can be stressful, overwhelming, and costly if fees and deadlines are overlooked. With decades of experience and tens of thousands of medical devices represented, our team knows how to ensure full compliance with FDA registration fees.  

We can act as your designated FDA Agent, communicating with the FDA on your behalf while managing your registration and device listing. We offer full end-to-end support throughout a variety of submission pathways, which includes: 

• Creating a custom strategy for your ideal pathway to approval 

• Preparing and submitting documentation 

• Translating feedback from the FDA into actionable steps to incorporate their guidance  

• Implementing and enhancing quality systems in your establishment to meet FDA requirements 

• Providing guidance on designing and conducting clinical trials 

• Offering post-approval support to maintain compliance throughout a product’s life-cycle 

Contact our team of experts today to learn how MedEnvoy Global can help your medical device reach new markets.