This article describes the new database of redacted 510k submissions that was recently made available online for immediate download by the US FDA.

Recently the FDA made redacted 510k submissions that were previously released through Freedom of Information Act (FOIA) requests available on-line for immediate download. There are 496 redacted 510k submissions available since November 2000–as indicated by the graph above. This is only a small fraction of the total number of 510k submissions, but the number that is available on-line will increase over time.

Types of redacted 510k Submissions

Of the 496 submissions, there is a mixture of submission types.

• 382 are traditional 510k submissions
• 97 are special 510k submissions
• 17 are abbreviated 510k submissions
• 14 were 3rd Party reviewed

What remains in a redacted 510k submission

The redacted versions do not include testing data, but you will find other goodies such as:

• 3rd Party SE memorandums (where applicable)
• Table of Contents
• Pre-market Notification Cover Sheet (i.e., FDA Form 3514)
• 510k Cover Letter
• Indications for Use (i.e., FDA Form 3881)
• 510(k) Summary
• Truthful & Accuracy Statement
• Device Description
• Executive Summary
• Substantial Equivalence Discussion (Partially Redacted)
• Summary of Biocompatibility Testing (Partially Redacted)
• Summary of Sterilization & Shelf-Life (Partially Redacted)
• Proposed Labeling
• Predicate Device Labeling
• Declarations of Conformity (i.e., FDA Form 3654)
• Deficiency Letter

This is valuable information that can be used to help select a potential predicate and to develop a verification and validation testing plan. If you are less experienced in the preparation of a 510k submission, it will help to see how other regulatory experts have organized their 510k submissions.

Learning more about redacted 510k submissions

To access this database, click on this link: Redacted FOIA 510k Database. To limit your search to only 510k submissions that are available as a redacted full 510k, just click on the box for “Redacted FOIA 510k.” If you are interested in learning more about how to make the most of this new resource, please sign up for my latest webinar on Monday, November 21 @ 9 am EST.

The article briefly explains the three types of 510k submissions and identifies when you should be submitting an abbreviated 510k instead of a traditional 510k.

Three types of 510k submissions

The FDA has three different target timelines for reviewing a 510k submission and issuing a decision regarding substantial equivalence (i.e., SE Letter):

1. Special 510k
2. Abbreviated 510k
3. Traditional 510k

Special 510k submissions

The first type is a special 510k submission. The FDA target timeline for a special 510k is 30 days, but you can only submit a Special 510k for a modification of your device that already has a 510k issued. Also, a Special 510k is only possible if the device modification requires a single technical discipline to review the change. For example, changes to software and materials require a review of software validation and biocompatibility. Therefore, two reviewer specialists must coordinate their efforts, and the review cannot be completed in 30 days. In this case, an abbreviated or traditional 510k must be submitted instead.

Abbreviated 510k submissions

The second type of 510k submission is an abbreviated 510k. The FDA target timeline for review is 60 days. If there is a recognized standard specific to the type of device you are submitting, or the FDA has issued a guidance document addressing that device classification, then an abbreviated 510k submission is recommended. For example, a dental handpiece (i.e., product code is ) has a special controls guidance document that explicitly written for dental handpieces, and the guidance states that an abbreviated 510k submission is recommended. Besides, the FDA recognizes the latest standard for dental handpieces: ISO 14457:2012 (FDA Doc # 4-206).

Traditional 510k submissions

The third type of 510k submission is a traditional 510k submission. The FDA target timeline for review is 90 days. If you are submitting a 510k for a new device, or the device modifications require more than one functional area of expertise, then a special 510k is not an option. If there is no recognized standard for the device type and the FDA has not issued the guidance of a special control for your device classification, then an abbreviated submission is also not an option. A traditional 510k submission is your only option in this case.

How frequently is an abbreviated 510k submission type used?

In September 2016, there were 260 510k SE decisions issued by the FDA. Here’s the breakdown by type:

• Special 510k – 47 submissions = 18%
• Abbreviated 510k – 8 submissions = 3%
• Traditional 510k – 205 submissions = 79%

In general, I think it requires a little more effort to write clear and concise summaries for the various sections of an abbreviated 510k than it does for a traditional 510k. But if you can get your product to market a month quicker then it’s worth it.

Additional Resources for 510k submissions

If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.

This article explains how to conduct design planning for a new medical device product launch that requires a 510k submission in 300 days or less.

One of the most valuable pieces of information you can receive is a plan for your medical device product launch. Some companies contact me, asking for help in implementing their quality system. You should be implementing this step last if you are a start-up company. Some companies contact me asking for help preparing their 510k submission. But you need to seek help much earlier. The best time to contact an expert for help with your product launch is 300 days before you want to launch your product.

Three Major Milestones of a Product Launch

Three major milestones must be completed before a medical device product launch can proceed. First, you need to complete the design specifications for your device. Second, you need to complete the design verification and validation activities and summarize this testing in a 510k submission or another type of regulatory submission. Third, you need to implement a quality system that meets the requirements of 21 CFR 820 and/or ISO 13485:2016. Each of these three major tasks can be completed in less than six months, but with proper planning and motivation, all three can be completed sequentially in less than one year for many products. Completing all three milestones in 300 days is possible.

Break Your Product Launch into Phases

Whenever I plan a design project, I break the overall product development into chunks that are easily understood, with measurable milestones, and I establish a timeline that is aggressive but possible. The design process typically has six phases, but several of these phases are shorter than you want, and the overall process is too long for a single chunk. Therefore, I decided to break the six phases into three pieces: 1) product development, 2) verification and validation, and 3) regulatory clearance. The end of the first chunk is marked by a “design freeze” where your team will conduct a design review and approve the final design outputs before you begin verification and validation of your product design. The second chunk is marked by the submission of a 510k or some other regulatory submission. The third chunk is marked by the completion of your quality system and receipt of your 510k clearance letter from the FDA.

How Long Should Each Phase of the Product Launch Be?

In the past, I would choose a timeline of approximately 3-4 months for each major phase of product launch. However, I have been learning a lot about goal setting, and I now target 100 days for the completion of most milestones. The reason is that 100 days is a time period over which most people can maintain their enthusiasm and motivation for completing a goal. If a goal takes longer than 100 days, then you should probably break down the goal into two or more smaller goals. If each of the three major phases of your product launch requires 100 days, then you can complete the overall product development and product launch within 300 days. One of the tools I recommend for planning and tracking your progress toward a 100-day goal is The Freedom Journal.

Product Launch Phase 1 – Your Design Plan

Your design plan should be the first thing you create. To create a design plan, you will need to identify the regulatory pathway–including all of the testing that is required for verification and validation of your new medical device. This design plan should identify all the design reviews, all the verification and validation testing that is required, and the regulatory approval process required before the product launch.

Product Launch Phase 2 – Preparing Your 510k Submission

Once you have approved your design outputs during the “design freeze,” now you need to complete the verification and validation testing, during this phase you will need to make sure that you have identified all the testing, and how many samples will be required for each test. You need to determine which steps of the testing process can be performed in parallel instead of performing tasks in series. For example, you will need to package and sterilize samples that are required for biocompatibility testing, but electrical safety testing samples can be non-sterile. Therefore, the packaging validation must be completed before biocompatibility testing, but the electrical safety and EMC testing can be performed in parallel with both activities. For most products, biocompatibility testing is one of the last tests that is typically completed, and the longest of these tests usually takes between 8-12 weeks. Therefore, 100 days is probably the fastest you can complete your verification and validation testing. During the entire verification and validation process, you should be preparing your 510k submission. This will ensure that the submission is ready when the last test report is received–instead of frantically rushing to complete the submission in just a few weeks at the end of the process.

Product Launch Phase 3 – Implementing Your Quality System

Many companies start their quality system at the beginning of the design process. However, you should only implement two procedures before completing your 510k submission: 1) design controls, and 2) risk management. These two procedures are needed to document your design history file (DHF) properly, and it is much harder to document your DHF after the design is completed. The balance of the procedures can be implemented in about 100 days, while your 510k submission should take between 90 and 180 days to receive clearance from the FDA. Therefore, you should be able to complete the quality system implementation before receipt of your 510k clearance letter.

“Rinse and Repeat” for Your Next Product Launch

Once you have completed your product launch, you should review the post-market surveillance from your customers during the first 90 days. I like to call this the 100-day review. One hundred days after the first product launch is the perfect time to conduct your first management review meeting. You should have your first internal audit completed during the first 100 days, and you should have a lot of great feedback from customers during the first 90 days of product use. Therefore, top management can review the customer feedback, internal audit results, and progress toward other quality objectives to identify improvement action items needed. These improvements may be quality system improvements and/or product improvements. One of the outputs of your first management review meeting should also be an identification of your next product development.

This article explains the content and format of a special controls guidance document issued for Class 2 medical devices regulated by the CDRH division of the US FDA.

There are many differences between Class 1 and Class 2 medical devices regulated by the FDA, but one of the primary differences is that many (not all) Class 2 medical devices have a special controls guidance document. Class 1 devices only have “general controls.” These “special” guidance documents can be found on the FDA website by searching the guidance document database. The title of each guidance document typically begins with “Class II Special Controls Guidance Document.” The middle of each title specifies the device type, and the end of the title states, “- Guidance for Industry and FDA Staff.” However, there are many exceptions.

Status of a Special Controls Guidance Document

A guidance document may be a final guidance or a draft guidance. Only the final guidance is considered official, however, draft guidance often indicate what the FDAs current thinking is on a topic. Draft guidance documents sometimes take years before they are approved as a final guidance. Sometimes the draft is so controversial that it will even be withdrawn. The FDA also publishes a list each year of planned guidance documents for the next fiscal year. Some of the final versions of special controls guidance documents were written in the 1990’s, but these documents remain the current final guidance until a new final guidance is approved. Often there is no urgent need to update a guidance document, because there are one or more active ISO Standards specific to the product classification and the standard(s) is recognized by the FDA.

Outline of a Recent Special Controls Guidance Document

Here is the general outline that is currently being used by the FDA for a special control guidance document for Class 2 devices:

1. Introduction
2. Topic – Background
3. Pre-Market Notification – Background
4. Scope
5. Risks to Health
6. Specific Device Description Requirements
7. Performance Studies
8. Device Specific Labeling
9. References

Each product classification has the potential for slightly different requirements due to the differences in types of devices. For example, in vitro diagnostic products do not have animal studies and typically have human clinical study requirements for the performance section of the guidance document. However, an implant is more likely to have details about the materials of construction, biocompatibility and sterilization.

Searching the Guidance Database

There are 8 fields that are searchable for the guidance database.

1. Product
2. Date Issued
3. FDA Organization
4. Document Type
5. Subject
6. Draft or Final
7. Open for Comment
8. Comment Closing Date on Draft

For a De Novo application, I sometimes need to create a proposed draft special controls guidance. For this activity, I prefer to find a representative template. In order to do this, I will typically use four of these search fields. First, I narrow the product field to “medical devices” and the FDA organization to “CDRH.” Second, I select “guidance documents” for the document type. Finally, I select “premarket” for the subject and “final.” This narrows the list to 374 documents. Not all of the 374 documents are specific to a product classification, because some of these documents cover more general premarket issues such as risks of wireless telemetry.

You can further narrow your search by adding a word or words to the keyword search field. Therefore, if you are looking for a specific guidance you can find it very quickly.

Format of Special Controls Guidance Documents

If you submit a proposed draft guidance to the FDA (anyone can do this), there is no specific required format. However, I recommend copying the most recent format used by the FDA in order to minimize the amount of work required by the FDA for modifying the guidance prior to publishing your guidance as a draft. You also do not need to include all the sections of a guidance. Some of the guidance documents only update certain sections where technological characteristics have recently changed significantly. Most importantly, if you have a strong reason for deviating from what the FDA has always done–do it. The format of guidance documents has changed since the 90’s and will continue to do so.

Additional Resources

If you are preparing a premarket notification (i.e., 510k submission), you might have more questions than just guidance document availability. You might be interested in purchasing “How to Prepare Your 510k in 100 Days” or the on-line 510k Course or one of our Live 510k Workshops.

In this article, you will learn how we created a device description template that can be used for US FDA and CE Marking submissions.

Webinar Training

Medical Device Academy also created a webinar on completing this device description template.

This device description template addresses the FDA Refusal to Accept (RTA) guidance document requirements. The template also serves as a summary technical document (STED) for submission to a Notified Body for CE Marking. You would think that it’s tough to screw up the device description, but the FDA screening reviewer is completing a new refusal to accept (RTA) checklist. That checklist has specific requirements for a device description. If you copy the device description from your draft IFU, you will probably receive an RTA letter on Day 15 of the RTA screening process. The review “clock” is reset to zero, and you have to revise your device description and re-submit.

Note regarding changes in the device description template:

The RTA Checklist is no longer relevant for 510k submissions. 510k must now be submitted using the new FDA eSTAR submission templates. This template is your attachment to meet the “Comprehensive Product Description and Principles of Operation Documentation” requirement. However, the FDA now conducts a technical screening rather than completing the RTA checklist. The section numbers are also no longer applicable in a 510k submission.

There are four specific requirements (questions 9-12) in section “B” of the RTA checklist, which is titled “Device Description.” In addition, there are similar requirements for inclusion in a device description for technical files and design dossier submissions to Notified Bodies. Rather than creating two different device description documents, I prefer a template that addresses each regulatory requirement in a single controlled document. Therefore, I created a template for the 510k submission device description with the following headings for Section 11 of the 510k submission:

• Product or Trade Name

• General Description – The general description must be consistent with the device description in the labeling, and this section of the document is intended to address section 13 of the refusal to accept (RTA) checklist.

• Indications for Use – We recommend keeping this separate section of the device description. You should copy the content of FDA Form 3881 verbatim, or the reviewer will indicate that your submission is inconsistent. In the eSTAR, the indications for use can be automatically populated in the 510(k) Summary from FDA Form 3881. We also have a webinar on indications for use.
• List of Devices – A list and description of each device for which a 510(k) clearance is requested in the submission. The list may refer to models, part numbers, sizes, etc. This document section addresses section 14c of the refusal to accept (RTA) checklist. Combining this section with section 3 of the template may be helpful, providing a table with a UDI device identifier for each product listed (if available).
• Intended Patient Population – The medical condition to be diagnosed and/or treated, and other considerations such as patient selection criteria.
• Intended User(s) -Each potential user group should be identified, and it should be stated if the device is intended for use by a healthcare professional, a layperson or both. Finally, this section should indicate if the device is for prescription use, over-the-counter use or both.
• Principles of operation of the device – This document section addresses section 14a of the refusal to accept (RTA) checklist.
• Risk class and applicable classification rule – This is only required for CE Marking, and we typically exclude this from our device description in a PreSTAR or eSTAR submission for the FDA. If you are preparing a device description for CE Marking, the risk classification is based on Annex VIII (MDR) and MDCG 2021-24.
• Conditions of Use (i.e., Environment of Use) – A description of proposed conditions of use, such as surgical technique for implants; anatomical location of use; user interface; how the device interacts with other devices; and/or how the device interacts with the patient. This section should also state where the product is used (i.e. home use or clinical use). This section of the document is intended to address section 14b of the refusal to accept (RTA) checklist.
• Novel Features – This is required for CE Marking, but in a 510k submission, we are trying to demonstrate how the subject device is equivalent to the predicate instead of highlighting novel features. Therefore, any novel features in a 510k should be technological characteristics that you can provide a justification and/or testing to support. This section is not for marketing.
• Components – Description of components, accessories, other medical devices, and other products that are not medical devices intended to be used in combination with the device. The 510k number should identify each component/accessory part of a previous submission. Any component(s)/accessory(s) that have not received prior clearance should also be identified. Sometimes, a side-by-side table for USA and EU markets is needed for accessories that are used in different markets. This document section addresses section 12a, b, and c of the refusal to accept (RTA) checklist.
• Accessories – Description of accessories, other medical devices, and other products that are not medical devices, which are intended to be used in combination with the device. Each accessory that was part of a previous submission should be identified by the 510k number. Any accessory(s) that have not received prior clearance should also be identified. This document section addresses sections 15a, b, and c of the refusal to accept (RTA) checklist. In the eSTAR, there is a subsection at the end of the Product Description section titled “System/Kit Components and Accessories.” If your device is intended to be marketed with multiple system/kit components or accessories, then you must attach a list of those components or accessories in the PreSTAR or eSTAR (see screenshot below).

• Configurations/Variants – Description or a complete list of the various configurations/variants of the device that will be available
• Functional Elements – General description of the key functional elements, formulation, composition, and functionality—including labeled pictorial representations (e.g., diagrams, photographs, and drawings)
• Raw Materials – This section is a duplicate of the section included for biocompatibility. Any raw materials incorporated into components of the device that are intended to make direct contact with the human body or indirect contact with the body should be listed. Any colorants should be included in this list of raw materials.
• Technical Specifications – Technical specifications of the device and any variants and accessories that would typically appear in the product specification are made available to the user, e.g., in brochures, catalogs, and the like.
• Drawings, Schematics, Illustrations, Photos and/or Figures – Representative engineering drawing(s), schematics, illustrations, photos, and/or figures of the device. This document section addresses section 14d of the refusal to accept (RTA) checklist. These drawings, photos, videos, etc. can be attached to the PreSTAR or eSTAR using the button shown in the screen capture below. The FDA requests schematics, drawings, or photos of the product packaging as an attachment to the PreSTAR or eSTAR as well. The best thing to attach for this requirement is a work instruction that illustrates where labeling is applied to the device and the different levels of packaging. This will describe the packaging and how the device is packaged and labeled.

• Similar & Previous Generations of the Device – Reference to similar and previous device generations. Ensuring these devices are included in the clinical evaluation report is important. If submitting a 510k submission, you want to ensure that any devices are registered and listed with the US FDA in the same product category. Creating a table that organizes the “similar” devices by intended use and technological characteristics may be necessary for a device with multiple predicates.
• Requirements Specific to the Special Controls Guidance Document – This template section addresses section 12 of the refusal to accept (RTA) checklist. When you complete the classification section of the PreSTAR or the eSTAR, the PDF template should automatically identify and Special Controls Guidance Documents that are applicable (see example below).

The last section of the device description is for any unique requirements specific to the special controls guidance document for the product classification I am working on. However, most of the requirements for a device description are met by the previous items in my outline. Therefore, I created a table that outlines each requirement of the Special Controls Guidance Document, and I provided a cross-reference to the section of the outline that includes this requirement. If requirements are not covered elsewhere in the document, I address them in the table. If there is no Special Controls Guidance Document, then I state that no Special Controls Guidance Document exists for the product.

This article summarizes five alternatives that medical device manufacturers have for regulatory approval in the US when a 510k submission predicate device cannot be identified.

The premise behind the FDA 510k regulation is that your new device is substantially equivalent to another device (i.e., predicate device) that is already on the market. Therefore, you only need to submit a premarket notification to the FDA instead of a premarket approval (PMA) submission. Most 510k submissions reference a similar device manufactured by a competitor, but what do you do when you can’t find a predicate device?

Your 5 Options if you cannot identify a 510(k) predicate device

1. Conduct a Clinical Study and Prepare a PMA Submission = $$$ + 2 years min.
2. Prepare a De Novo Submission = avg. review time was 307 days in 2019
3. Submit a 510k with Your Best, Poor Choice & Expect One of Two Responses: Refusal to Accept (RTA) or Not Substantially Equivalent (NSE)
4. Request a Pre-Sub Meeting with the FDA = 60-day Delay at the front of Project
5. Submit a 513(g) Request to the FDA = $ + 60-day Delay at Front of Project

Option 1 – Clinical Study & PMA preparation

If you cannot identify a predicate device, you may need to conduct a clinical study to demonstrate that your new device is safe and efficient. Some devices even require an investigational device exemption (IDE) approval from the FDA if the risks of the device are significant. If your device presents significant risks, likely, the De Novo process (Option #2 below) will not be an option, and the device will be considered a Class III device by the FDA. In this case, the fastest pathway to regulatory approval is a modular PMA submission. The minimum timeline for this type of submission is typically two years, and the FDA user fee for a PMA submission is very high–unless you are a start-up company and this is your first product. The following FDA webpage summarizes the process for a modular PMA.

Option 2 – De Novo Classification Request if there is no predicate device

Originally the De Novo process was created with IVD products in mind where the technological characteristics are nearly identical between the two devices. Still, the intended use is different (i.e., the device is used to diagnose a different disease). The problem with the original process is that you had to submit a 510k and have it rejected before you were allowed to submit a De Novo application. Now the De Novo process allows two pathways. A company can submit a 510k, have it rejected with a “not substantially equivalent” (NSE) letter, and then submit a De Novo application. The new option allows a company to skip the initial 510k submission and submit a De Novo application first. This extends the decision time from 90 days to 120 days, but the previous option took even longer. We recorded a webinar on the De Novo Classification Request Process in 2019. The FDA also recently updated the De Novo webpage to summarize the regulations related to the De Novo new final rule. The following FDA webpage summarizes all the De Novo Classification Requests recently granted.

Option 3 – Submit a 510k with whatever device you found

This is probably not your best approach, but sometimes it’s worth a shot to see what the FDA will say instead of waiting to schedule a pre-submission meeting, and this approach doesn’t eliminate option #2. There are two likely outcomes from this approach. First, the reviewer screening your 510k submission during the 15-day, refusal to accept (RTA) process will determine that you have not selected a suitable predicate device, and you will receive an RTA letter. In this case, you have an answer in just 15 days. You should never accept your first RTA letter. You should make the requested changes the reviewer indicates and re-submit. The FDA’s goal is to have all submissions make it through the RTA process on the second try. Therefore, you might have more success on the second try with another predicate or just by fixing other problems the reviewer identified.

The other possible outcome of this approach is that you will make it through the RTA process, but your submission will be determined to be NSE. In this case, you will receive an NSE letter from the FDA, and it will suggest options–typically a PMA or a De Novo submission. If a De Novo submission is a good option, it will be stated in the letter.

Option 4 – Request a pre-sub meeting to discuss a potential predicate device

If you are not able to identify a suitable predicate, you might consider preparing a classification rationale and selecting a potential predicate. Then this information can be summarized in a pre-submission meeting request to the FDA. The FDA will respond within 75-90 days from your submission. If you are still developing your device and you have not started any performance testing, then this option may be your best approach. I recently recorded a webinar on pre-submission meeting requests.

The webinar includes specific dos and don’ts for pre-submission meetings. There is also final guidance for the pre-submission program that was released last year on February 18, 2014. The FDA pre-submission guidance document was updated again on January 6, 2021, and we recorded a webinar on pre-submission meeting requests.

Option 5 – Submit a 513(g) application to identify the regulatory pathway

When a company has difficulty identifying a 510k submission predicate device, the FDA recommendation is to submit a 513(g) application. As I indicated in a past blog, the 513(g) process may not be your best choice for two reasons. First, the 513(g) process takes 60 days before the FDA responds. Second, the 513(g) process has a user fee that is higher than hiring a consultant to do the same research. Since the FDA 513(g) response is “non-binding,” the FDA’s opinion doesn’t necessarily hold any more weight than an experienced consultant. Therefore, paying a consultant to do the research and then requesting a pre-sub meeting is probably a better approach, but the timeline for a 513(g) submission is slightly shorter.

Do you still have questions about 510(k) predicates?

Rob Packard recorded an updated webinar on the topic of predicate selection. If you are interested in this topic, please register for the webinar. The updated webinar was recorded on March 28, 2022.

This explains the differences between the regulatory pathways for a Humanitarian Use Device (HUD) or HDE and 510k submissions.

HDE Application

In September 2019, the FDA released a final guidance document explaining the regulatory process for a Humanitarian Device Exemption (HDE) Application. HUD designation is for a product that affects less than 8,000 patients per year in the United States. The limitation of 8,000 There are three steps required before a HUD may be used at a user facility:

1. HUD Designation Request to Office of Orphan Products Development (OOPD)
2. HDE Application to Center for Devices and Radiological Health (CDRH)
3. Investigational Review Board (IRB) approval of using the HUD

Note: The above regulatory pathway may not apply to combination products. In the case of combination products, you should contact the Office of Combination Products (OCP).

Major Differences between the HDE Application and a 510k submission

• Unlike the 510k process, HDE approval is device approval rather than “clearance” for marketing and distribution.
• If another equivalent (an actual term used is “comparable”) device is already being legally marketed, then the FDA may not approve an HDE application. In contrast, the first requirement for the determination of substantial equivalence of a subject device for a 510k submission is that the predicate device must be a legally marketed device that is equivalent.
• There are no user fees, while 510k submissions generally are subject to FDA user fees; pediatric-only products are an exception to the requirement for 510k user fees.
• There is no requirement to demonstrate the effectiveness of devices in an HDE application. Instead, devices approved for HDE must provide an acceptable benefit/risk analysis.
• HDE-approved devices are not generally eligible to make a profit. Any device that a manufacturer intends to sell for more than $250 requires a report issued by an independent public accountant.
• IRB approval for the use of HUD-approved marketing is required, but IRB approval is not for a clinical study, and IRB approval is not required in the case of an emergency.

The FDA guidance document also explains how HDE approval is different from pre-market approval (PMA).