Modifying an approved medical device is more than a technical challenge; it’s a strategic business decision. Whether you’re aiming to enhance performance, reduce manufacturing costs, or add a new feature, your commercial goals are directly tied to regulatory requirements. For any Class III device, implementing a change that could affect its safety or effectiveness means preparing and submitting a PMA supplement. This process is not a roadblock to innovation but a structured part of it. Successfully managing your supplement submission ensures that your strategic improvements can reach the market compliantly, protecting your investment, your reputation, and the patients who rely on your technology.
Key Takeaways
- Choose the Right Supplement Pathway: The type of supplement you submit dictates your entire project timeline and data requirements. Correctly identifying the right path from the start is the most critical step for creating a realistic budget and go-to-market strategy.
- Build a Clear and Complete Submission Package: Your submission must tell a convincing story. Provide a detailed rationale for the modification, support it with robust testing data, and follow all electronic formatting rules to prevent simple rejections and reduce FDA questions.
- Maintain Compliance After Approval: Gaining approval is a milestone, not the finish line. You must integrate the approved change into your Quality Management System, continue post-market monitoring, and adhere to all reporting conditions to ensure long-term compliance and patient safety.
What is a PMA Supplement?
Think of a PMA supplement as an official update to your device’s original Premarket Approval (PMA). It’s a formal submission you send to the FDA when you plan to make a change that could potentially affect the safety or effectiveness of your approved medical device. This isn’t just a minor notification; it’s a critical step that allows the FDA to review and approve your proposed modifications before they are implemented. This process ensures that your device remains safe and effective for patients throughout its entire lifecycle.
Successfully getting a device through the initial PMA process is a massive achievement. The supplement process is designed to protect that hard-won approval and maintain the public’s trust in your product. Whether you’re changing a manufacturing process, updating the design, or altering the labeling, the PMA supplement is the regulatory pathway to get it done correctly. It serves as a formal amendment to your original application, providing the FDA with the necessary data to evaluate the impact of your changes and give you the green light to proceed.
First, What is Premarket Approval (PMA)?
Before we get deeper into supplements, let’s quickly recap what a Premarket Approval (PMA) is. The PMA process is the FDA’s most stringent regulatory pathway for medical devices. It’s reserved for Class III devices—those that pose the highest risk to patients, such as life-supporting or life-sustaining devices like pacemakers or heart valves. Because of the high-risk nature of these products, the PMA application requires extensive scientific and clinical evidence to prove the device is both safe and effective for its intended use. It’s a comprehensive and demanding process, but it’s the necessary standard for bringing high-risk, innovative medical technology to the market.
Why Do You Need a PMA Supplement?
Once your device has earned its PMA, your work isn’t over. The device you manufacture a year from now might not be identical to the one you originally got approved. You might find a better material, a more efficient manufacturing technique, or want to update the software. Any change that could impact the device’s safety or effectiveness must be reported to and approved by the FDA through a PMA supplement. This requirement is in place to ensure the device continues to meet the original standards of safety and effectiveness, protecting patients from unvetted changes. It’s a key part of post-market surveillance and lifecycle management.
Identify When a Device Change Requires a Supplement
Knowing when to submit a supplement is crucial for staying compliant. According to FDA regulations, you must submit a PMA supplement for review and approval before making any change that has the potential to affect your device’s safety or effectiveness. The specific requirements cover a wide range of modifications. Common triggers include changes to the device’s design or performance, new or different materials, significant alterations to the manufacturing process or facility, and updates to the sterilization method. Even changes to the labeling, such as adding new indications for use or warnings, require a supplement. Proactively identifying these changes is the first step in a successful submission strategy.
Explore the Types of PMA Supplements
Once you’ve determined that a change to your medical device requires a PMA supplement, the next step is figuring out which type to submit. The FDA has established several different pathways for PMA supplements, and the one you choose depends entirely on the nature and significance of your modification. Think of it like different lanes on a highway—some are for express trips, while others are for heavy cargo that needs careful inspection. Choosing the wrong one can lead to delays, extra questions from the FDA, and unnecessary headaches. Understanding the distinctions between each supplement type is the first step toward a streamlined and successful submission process. Let’s walk through the five main types so you can confidently identify the right path for your device’s update.
Panel-Track Supplements
This is the most intensive review pathway, reserved for major changes that could significantly alter your device. Think of a completely new design or a new indication for use—changes so substantial they often require new clinical data from patient studies. The FDA will conduct a thorough review, sometimes bringing in an advisory panel of outside experts to weigh in. Because the stakes are high, this process is the most rigorous and time-consuming of all the supplement types. It’s essential to have a robust data package ready before heading down this path.
180-Day Supplements
If your change is significant but doesn’t quite rise to the level of a Panel-Track Supplement, the 180-Day Supplement is likely your route. This pathway is for important modifications that affect the device’s safety or effectiveness. Common examples include major changes to the design, materials, software, or labeling. The FDA has up to 180 days to review your submission, which will likely need to be supported by new non-clinical lab testing to validate the change. It’s a comprehensive review for substantial updates that require careful FDA oversight.
Real-Time Supplements
For more minor modifications, the Real-Time Supplement offers a more collaborative and faster process. This is intended for smaller changes to your device’s design, software, sterilization, or packaging, as long as the modification doesn’t change the device’s intended use. The “real-time” part refers to the review process itself, where you can schedule a meeting with the FDA to discuss and review the change together. This direct interaction can help resolve questions quickly and accelerate the approval timeline for less risky updates.
Special PMA Supplements
This supplement has a very specific and important purpose: to implement a change that improves the safety of your medical device. This could be a modification to address a newly identified risk or to enhance a safety feature. What makes this pathway unique is that it’s the only one that allows you to distribute your modified device before receiving FDA approval. You must submit the supplement and can then implement the change. It’s designed to get critical safety enhancements to patients as quickly as possible.
30-Day Notices
Sometimes, the change you need to make is not to the device itself, but to how it’s made. A 30-Day Notice is used for modifications to your manufacturing processes or procedures that could affect the device’s safety or effectiveness. It’s important to note this doesn’t cover changes to the manufacturing facility’s location or fundamental design changes. After you submit the notice, the FDA has 30 days to review it. If you don’t hear back with questions or a request to file a different supplement, you can implement the change.
Assemble Your PMA Supplement Submission
Once you’ve figured out which type of PMA supplement you need, the next step is to build a comprehensive and persuasive submission package. Think of this as creating a detailed story for the FDA reviewer—one that clearly explains the change, why it’s necessary, and how you’ve proven it maintains the device’s safety and effectiveness. A disorganized or incomplete submission can lead to delays, requests for more information, or even a rejection. Getting it right from the start is your best strategy for a smooth review process.
Putting together a strong submission involves more than just filling out forms. It requires careful planning and attention to detail across several key areas. You’ll need to gather all the necessary documentation, compile robust supporting data, detail your quality control processes, and ensure everything is formatted correctly according to FDA guidelines. Each piece of the puzzle, from the technical data to the cover letter, plays a critical role in demonstrating your commitment to compliance and patient safety. Let’s walk through the essential components you’ll need to assemble for a successful submission.
Gather Your Required Documentation
The foundation of your PMA supplement is the documentation that describes the change in detail. According to the FDA, a PMA supplement is required for any modification that could affect your device’s safety or effectiveness. Your goal is to provide a complete picture of what’s changing and why.
Start by clearly identifying your original PMA number. Then, provide a thorough description of the modification, whether it’s a change in design, materials, or manufacturing process. This section should include updated device descriptions, revised labeling or packaging inserts, and any relevant engineering drawings or schematics. Be specific and transparent. The reviewer needs to understand the “before” and “after” to properly evaluate the impact of your proposed change.
Compile Supporting Data
Every claim you make about your device modification must be backed by solid evidence. The type and extent of data you need will depend on the nature and risk level of the change. A minor change might only require data from bench testing or material characterization, while a more significant change, like a new indication for use, will demand comprehensive clinical or non-clinical study results.
Your submission should present this data in a clear, organized, and easy-to-follow format. This includes the full study protocols, raw data, and a summary of the results and your conclusions. The FDA needs to see that you’ve conducted the right tests to validate the change and that the results confirm the device remains safe and effective. As outlined in 21 CFR 814.39, this supporting data is a non-negotiable part of the submission.
Detail Your Quality Control Measures
The FDA needs assurance that your change is not a one-off success but can be consistently and reliably implemented. Your submission must demonstrate that the modification is managed under your established Quality Management System (QMS). This means providing documentation on your design controls, risk management activities, and process validation associated with the change.
You should also outline your plans for post-market monitoring. This includes adhering to the Medical Device Reporting (MDR) regulation and any specific PMA Conditions of Approval from your original submission. Showing that you have robust quality control and a plan for ongoing surveillance gives the FDA confidence that you are prepared to manage the device throughout its entire lifecycle, ensuring patient safety long after the supplement is approved.
Follow Electronic Submission Guidelines
How you submit your package is just as important as what’s in it. The FDA has specific technical requirements for electronic submissions, and failing to meet them can result in an immediate refusal to accept your file. This can cause significant and completely avoidable delays. Most PMA submissions are now handled through the FDA’s eCopy or eSTAR programs.
Before you submit, take the time to carefully review the most current FDA guidance on electronic submissions. Ensure your files are in the correct format, named according to the proper conventions, and organized as specified. Following these guidelines precisely shows the FDA that you are diligent and professional, and it helps your submission move into the review queue without any administrative hiccups.
Write a Compliant Cover Letter
Your cover letter is the first document the FDA reviewer will see, and it sets the tone for your entire submission. It should serve as a clear and concise roadmap for your application. A well-written cover letter goes beyond a simple greeting; it’s a critical tool for guiding the reviewer through your package efficiently.
Be sure to include your original PMA number, the legal name of your company, and the specific type of PMA supplement you are submitting (e.g., 180-Day Supplement, Special PMA Supplement). Provide a brief but comprehensive summary of the proposed change and a clear rationale for it. Finally, include a detailed table of contents that outlines every document included in the submission. This helps the reviewer quickly locate information and understand the structure of your argument.
Device Changes That Require a PMA Supplement
Once your device has Premarket Approval, your work with the FDA isn’t over. Any time you plan to make a significant change to your device, you need to consider whether it requires a PMA supplement. The FDA’s primary concern is that the modification doesn’t negatively affect the device’s safety or effectiveness. Let’s walk through some of the most common changes that will have you preparing a supplement submission.
Manufacturing and Facility Changes
If you’re planning to move production to a new factory or facility, you’ll need to file a PMA supplement. This applies to any location where your device is made, processed, or packaged. The FDA needs to review and approve this change to confirm that the new environment and processes won’t compromise your device’s quality or performance. It’s a critical step to ensure that the standards established in your original PMA are maintained, regardless of where the manufacturing takes place. The FDA provides detailed guidance on PMA supplements and amendments to help you prepare the right documentation for this type of change.
Design and Component Modifications
Innovating on your approved device is a great way to stay competitive, but it often requires FDA approval. Any modification that could affect the safety or effectiveness of your device—including changes to its design, components, or core functionality—necessitates a PMA supplement. This could be anything from altering a physical feature to swapping out an internal part. Before you implement these changes, the FDA must review them to ensure they don’t introduce new risks or alter how the device performs. Think of it as getting a green light to ensure your improvements are officially recognized as safe and effective for users.
Introducing New Materials
Switching the materials used to build your device might seem like a simple update, but it’s a significant change in the eyes of the FDA. A PMA supplement is required when you introduce new materials or alter the manufacturing process in a way that could impact the device. This is because a new material can change how the device interacts with the body, its durability, or its overall performance. The FDA needs to assess these changes to confirm that the device remains safe and effective. Your supplement should include data demonstrating that the new material meets all necessary quality and safety standards.
Sterilization Method Changes
Sterilization is a critical process for many medical devices, and any change to your method requires a PMA supplement. Whether you’re switching from ethylene oxide to gamma irradiation or simply adjusting the parameters of your current process, the FDA must review it. The goal is to ensure the new sterilization method effectively eliminates microorganisms without damaging the device or leaving harmful residues. Submitting a supplement allows the agency to verify that your device will continue to be sterile and safe for patient use after the change is implemented, preventing any compromise to its integrity or effectiveness.
New Indications for Use
If you discover your device can be used for a new medical purpose, that’s a fantastic opportunity to expand your market. However, you can’t start marketing it for that new purpose without FDA approval. Adding a new indication for use requires a PMA supplement. The FDA needs to review clinical or non-clinical data that supports the device’s safety and effectiveness for this new application. This process ensures that any new claims you make are backed by solid evidence and that the device performs as expected for its expanded purpose, protecting both patients and your business.
What to Expect During the FDA Review
Submitting your PMA supplement is a huge milestone, but the work isn’t over yet. The FDA review process is an active phase that requires your attention and preparedness. Think of it less like waiting for a grade and more like a collaborative dialogue with the agency. The FDA’s goal is to ensure the device’s continued safety and effectiveness, and your role is to provide clear, comprehensive information to support your proposed changes. Knowing what’s coming can help you manage timelines, allocate resources, and respond to the FDA efficiently. Let’s walk through the key stages of the review so you can feel confident and in control.
Know the Review Timeframes
Understanding the FDA’s review clock is essential for your business planning. After the agency approves a PMA, you must submit a PMA supplement for review and approval before you can make any change that affects the safety or effectiveness of your device. The type of supplement you submit dictates the review timeframe, which can range from 30 to 180 days. For example, a 180-Day Supplement is for significant changes, while a 30-Day Notice is for minor modifications. Accurately classifying your change is the first step to setting realistic expectations for when you can implement it. Misclassifying a change can lead to delays and additional questions from the agency, so it’s critical to get it right from the start.
Prepare for Information Requests
It’s common for the FDA to have questions during its review. Being ready for these information requests can prevent your submission from stalling. The agency may ask for clarification, additional data, or further justification for your proposed change. If your company submits a “major” amendment, such as new study data, the FDA’s review time can be extended by up to 180 days. To minimize delays, your initial submission should be as complete as possible. Anticipate potential questions and include the supporting data upfront. When you do receive a request, a prompt, thorough, and well-organized response demonstrates your commitment to compliance and can help keep your review on track.
Understand FDA Communication Protocols
Effective and professional communication with the FDA is key to a smooth review. The agency has established protocols for interaction, and following them shows you’re a serious and knowledgeable partner. The FDA is more accessible than many people think; for instance, the agency allows stakeholders to send in comments about its guidance documents at any time. This openness creates opportunities for dialogue and clarification. For your submission, you’ll have a designated point of contact at the agency. Keep your communication clear, concise, and focused on the topic at hand. Documenting all interactions provides a clear record and helps ensure everyone is on the same page throughout the process.
Anticipate Potential Decision Outcomes
At the end of the review, the FDA will issue a decision. The most common outcomes are approval, approvable, or not approvable. It’s also important to understand your responsibilities after a decision is made. For example, the PMA Conditions of Approval outline ongoing obligations. The FDA states that if an event is subject to reporting under both the MDR Regulation and your PMA’s “Conditions of Approval,” you must submit the required reports within specific timeframes. Being prepared for these post-approval requirements, including potential reporting and record-keeping, ensures you can maintain compliance long after your supplement is approved. This foresight helps you integrate the approved change into your quality system without any compliance gaps.
Consider the Business Impact
Submitting a PMA supplement is more than just a regulatory task; it’s a strategic business decision with wide-ranging effects. Before you even begin compiling documents, it’s crucial to step back and look at the bigger picture. How will this change and the subsequent submission process affect your company’s finances, market position, and internal resources? Thinking through these impacts ahead of time helps you build a realistic strategy, secure the necessary budget and buy-in, and prepare your teams for the road ahead. A well-considered plan can be the difference between a smooth approval and a costly, drawn-out process that stalls your growth.
Factor in the Costs
The financial investment for a PMA supplement goes far beyond the FDA submission fees. You need to account for the cost of any additional testing, clinical data generation, and potential outside consulting expertise required to support your application. Internally, consider the staff hours that will be dedicated to preparing the submission and responding to FDA inquiries. The PMA process is often dreaded by manufacturers precisely because of these financial and operational uncertainties. Creating a detailed budget that anticipates both direct and indirect costs will prevent surprises and ensure your project is adequately funded from start to finish.
Assess the Impact on Market Access
Any modification that requires a PMA supplement cannot be implemented until you receive FDA approval. This waiting period can directly impact your product’s availability and your ability to respond to market demands. If the change is intended to improve the device or expand its use, a lengthy review could delay your entry into new markets or leave you vulnerable to competitors. A change affecting the safety or effectiveness of your device must be properly vetted, so it’s essential to build the FDA’s review timeline into your commercialization strategy to set realistic expectations for your launch and sales teams.
Evaluate Your Competitive Position
The PMA supplement process can either strengthen or weaken your position in the marketplace. Successfully gaining approval for a new feature or indication for use can give you a significant competitive advantage. On the other hand, if competitors are able to make similar modifications through a less stringent pathway, you might find yourself falling behind. It’s important to analyze the regulatory landscape and understand how your proposed changes stack up against what others are doing. This strategic insight will help you prioritize modifications that offer the greatest return and solidify your place in the market.
Plan Your Resource Allocation
A successful PMA supplement submission requires a dedicated team and a clear allocation of resources. This isn’t a task that can be squeezed in between other projects. You need to assign specific team members to manage the submission, gather data, and serve as the point of contact for the FDA. Your planning should also account for ongoing compliance duties. For instance, you must continue to meet all existing reporting requirements, including those under the MDR Regulation and the original Conditions of Approval for your PMA. Proactive resource planning ensures the submission process runs smoothly without disrupting your day-to-day quality and regulatory obligations.
Maintain Compliance and Manage Risk
Getting your PMA supplement approved is a huge milestone, but it’s not the end of your regulatory journey. Once your modified device is on the market, your focus shifts to maintaining compliance and proactively managing risk. This ongoing process is crucial for ensuring patient safety, protecting your business from potential penalties, and upholding your reputation. A solid post-approval strategy involves staying on top of your quality system requirements, continuously assessing risk, monitoring your device’s performance in the real world, and having a clear plan to manage any future changes. Think of it as a system of checks and balances that keeps your operations smooth and your device safe for the long haul. By integrating these practices into your workflow, you can confidently manage your device’s entire lifecycle while staying in good standing with the FDA.
Meet Quality System Requirements
Your quality management system (QMS) is the backbone of your compliance efforts. After your device modification is approved, you must continue to adhere to all established quality system regulations. This means any change, no matter how small it seems, needs to be documented and evaluated through your established processes. The FDA is clear that after it approves a PMA, an applicant must submit a PMA supplement for review before making any change that could affect the device’s safety or effectiveness. Diligent record-keeping, consistent process validation, and regular internal audits are non-negotiable. This ensures that every device you produce consistently meets the approved specifications and maintains the highest standards of quality and safety.
Develop a Risk Assessment Strategy
A proactive risk assessment strategy is essential for identifying potential issues before they become serious problems. Your initial risk analysis was a key part of your PMA submission, and this process should continue throughout your device’s lifecycle. For every change you consider, you need to evaluate its potential impact on device safety and performance. Choosing a less stringent regulatory pathway without proper justification can be risky. As one study points out, this could mean devices are modified without the adequate rigor of regulatory review, potentially missing safety risks. A robust risk management plan helps you make informed decisions, justify your chosen supplement type, and demonstrate your commitment to patient safety to the FDA.
Plan for Post-Approval Monitoring
Once your modified device is available to the public, you have a responsibility to monitor its performance and report certain events to the FDA. This is a critical part of post-market surveillance. Your plan should detail how you will collect, analyze, and act on data from complaints, clinical studies, and other sources. The FDA’s Conditions of Approval for a PMA often include specific reporting requirements. If an event is reportable under both the Medical Device Reporting (MDR) regulation and your PMA conditions, you must submit the required reports within the specified timeframes. Having a clear, documented procedure for this ensures you meet all your obligations and can respond quickly to any safety signals.
Create a Compliance Maintenance Plan
A compliance maintenance plan acts as your roadmap for staying on track with all regulatory requirements long-term. This living document should outline your procedures for handling future device changes, managing documentation, and preparing for potential FDA inspections. It should also include timelines for specific submissions. For example, for certain changes, you may be able to use a 30-day notice, which allows you to distribute the device 30 days after the FDA receives your submission, provided the agency doesn’t raise any objections. By mapping out these processes in advance, you can manage changes efficiently, minimize disruptions to your distribution, and ensure your team is always prepared to meet FDA expectations.
Set Your PMA Supplement Up for Success
Submitting a PMA supplement can feel like a major hurdle, but with the right strategy, you can make the process much smoother. A successful submission isn’t just about filling out forms; it’s about demonstrating a clear, well-documented, and compliant approach to your device modification. By focusing on meticulous preparation and proactive planning, you can build a strong case for your supplement and minimize the back-and-forth with the FDA. Let’s walk through the key steps to get your submission ready for a successful review.
Aim for Flawless Documentation
Your goal is to submit flawless documentation from the get-go. The FDA defines a PMA supplement as the submission required for any change that affects the safety or effectiveness of your approved device. Think of your submission package as the complete story of your modification. It needs to be clear, comprehensive, and easy for the reviewer to follow. This means including detailed descriptions of the change, robust supporting data, and a clear rationale. Incomplete or confusing documentation is one of the quickest ways to receive questions from the FDA, which inevitably leads to delays. Taking the time to organize and polish your PMA supplements and amendments will pay off.
Manage Your Timeline Effectively
Understanding and planning for the FDA’s review timeline is critical for your business operations. Different supplements have different clocks. For example, with a 30-Day Notice, you can typically distribute your device 30 days after the FDA receives your submission, unless the agency contacts you with concerns. Other supplements, like a 180-Day Supplement, have a much longer review cycle. It’s essential to identify the correct pathway for your change and build a realistic project timeline around it. Always factor in extra time for preparing the submission and for the possibility that the FDA may have questions that pause the review clock. Effective timeline management prevents launch delays and keeps your internal teams aligned.
Integrate Regulatory Planning Early
Don’t treat your PMA supplement as a final checklist item. Instead, integrate regulatory planning into the earliest stages of your product modification process. According to 21 CFR 814.39, you must submit a supplement for review and approval before making a change that affects the device’s safety or effectiveness. By involving your regulatory team from the start, you can design your modifications with compliance in mind. This proactive approach helps you identify the necessary testing and documentation requirements upfront, saving you from costly and time-consuming rework later. It ensures that your product development and regulatory strategies are perfectly in sync.
Avoid These Common Pitfalls
One of the most significant mistakes a manufacturer can make is choosing a less stringent regulatory pathway than required. While it might seem like a shortcut, this approach can backfire. Attempting to modify a device without an adequate regulatory review can introduce unforeseen safety risks and lead to serious compliance issues down the road. Other common pitfalls include submitting insufficient data to support the change, failing to provide a clear scientific rationale, or having inconsistencies across different sections of your submission. Double-checking that your evidence is robust and your arguments are sound is a crucial final step before you submit.
Related Articles
- Navigating the Regulatory Pathway for Medical Devices – Guide
- Your Guide to Regulatory Pathways for Medical Devices
Frequently Asked Questions
What’s the real difference between an original PMA and a PMA supplement? Think of your original Premarket Approval (PMA) as the foundational license that allows your high-risk medical device on the market. It’s the result of a massive effort to prove your device is safe and effective from the ground up. A PMA supplement, on the other hand, is an update or amendment to that original license. You use it to get FDA approval for a specific change you want to make to your already-approved device, ensuring the product remains safe and effective as it evolves.
How do I know for sure if a change I’m making requires a supplement? The guiding principle is whether your proposed change could potentially affect the safety or effectiveness of your device. This is a broad standard that requires careful judgment. There isn’t a simple checklist, but common triggers include modifications to the design, materials, manufacturing process, or even the labeling. The best approach is to conduct a thorough risk assessment for any change you consider. If you’re on the fence, it’s always wiser to prepare a supplement than to risk non-compliance.
What is the most common mistake companies make with their PMA supplement submissions? A frequent pitfall is providing insufficient data to justify the change. It’s easy to underestimate the level of evidence the FDA needs to see. Your submission must include a strong scientific rationale backed by solid testing data that proves your modified device is just as safe and effective as the original. A submission with weak or incomplete data almost always results in questions from the FDA, which can cause significant and costly delays in the review process.
Can I start selling my modified device while the FDA is reviewing my supplement? In almost all cases, no. You must wait for the FDA to officially approve your supplement before you can implement the change and distribute the modified device. The single exception is the Special PMA Supplement. This specific pathway is reserved for changes that are intended to enhance the safety of your device. It allows you to make the safety improvement and distribute the device after you’ve submitted the supplement but before you receive final approval.
What happens if I make a change without getting the required supplement approved? Making a significant change to your device without the necessary FDA approval is a serious compliance violation. This can lead to significant regulatory actions, including warning letters, fines, mandatory product recalls, and damage to your company’s reputation. It puts your original PMA in jeopardy and, most importantly, can introduce unknown risks to patients. The supplement process exists to protect both the public and your business.