First Mistake: Not Involving a Regulatory Affairs Professional in the Early Development Stages

Developing a medical device without regulatory affairs input often leads to a delayed launch and increased costs. The complexity of the US FDA and EU regulations and standards can be confusing to startup companies. Regulatory affairs professionals can give you guidance on the eventual classification of your device, which defines the level of documentation required to obtain approval. Identifying and mitigating risks early in the development process is also essential for ensuring the safety and efficacy of the medical device.  Regulatory affairs professionals can help assess regulatory risks associated with the device’s design, intended use, manufacturing processes, and clinical data requirements. We advise clients to check in with regulatory professionals early and often when designing a new medical device.

Second Mistake: Underestimating the Cost of Bringing a Medical Device to Market

The costs associated with bringing a medical device to market are substantial. Depending on the device’s risk classification, companies can expect to spend hundreds of thousands, if not millions, of dollars as they take their device from concept to clearance. Understanding the costs associated with regulatory compliance, product development, manufacturing, clinical trials, and marketing allows manufacturers to create realistic budgets and secure adequate funding.

 Companies risk underestimating their financial needs without a clear understanding of these expenses, leading to funding shortages and delays in product development or market entry. Cost estimation provides insight into potential financial risks associated with the development and commercialization process. Manufacturers can identify areas where costs may exceed projections and develop contingency plans to mitigate financial risks. Additionally, understanding the cost implications of regulatory requirements helps companies assess the feasibility of bringing their device to market within budgetary constraints.

Third Mistake: Overly Broad or Unsubstantiated Claims

The US FDA and EU regulatory body require medical devices to undergo rigorous testing and evaluation to ensure their safety and effectiveness. The Indication for Use for the device must be focused and accurate. Making your Indication for Use overly broad risks rejection from your approval authority. We often advise clients to apply for a narrow indication on their first submission and then expand that indication on subsequent submissions.

Making exaggerated or unsupported claims about a medical device’s capabilities raises concerns. Marketing material must balance a fine line between “fluffery” and unsubstantiated claims.  Off-label usage does occur, but device manufacturers are prohibited from marketing a device for any use other than the approved Indication for Use. Engaging in misleading marketing practices undermines the ethical responsibility healthcare providers uphold and can harm patients by promoting ineffective or unsafe treatments. Making multiple unsubstantiated claims about a medical device can have severe consequences for startup companies, including regulatory sanctions, legal liabilities, damage to reputation, market rejection, loss of investor confidence, and ethical concerns. Startups must prioritize transparency, integrity, and evidence-based communication when promoting their products in the healthcare industry.

Fourth Mistake: Weak Document Control and Quality Management System

The US FDA and the EU regulatory body require medical device manufacturers to establish and maintain robust quality management systems (QMS) to ensure the safety and effectiveness of their products. A weak QMS can lead to non-compliance with regulatory requirements, potentially resulting in delays in product approval or market withdrawal. Document control and QMS are essential for maintaining the integrity of critical documents, such as design specifications, manufacturing procedures, and quality records. Without effective document control, companies risk using outdated or incorrect documents, which can compromise the safety and efficacy of the medical device. 

A weak QMS may also lead to inconsistencies in product quality and performance. Document control and QMS are crucial in identifying, assessing, and mitigating risks associated with developing, manufacturing, and distributing medical devices. Inadequate document control makes it difficult to track changes and updates, increasing the likelihood of errors or deviations that could pose risks to patient safety. A weak QMS may also result in inadequate risk management practices, leaving the startup vulnerable to potential hazards and liabilities.

 Traceability is essential in the medical device industry to ensure accountability and facilitate recalls or corrective actions when necessary. A robust document control system enables the startup to track the history and status of documents throughout their lifecycle, including revisions, approvals, and distribution. Without proper document control, tracing the origin and handling of critical documents becomes challenging, impeding the ability to effectively address quality issues or regulatory inquiries.

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May 15, 2024

Time is Running Out: All MDD Certificates Expire May 26th, 2024

Roseville, MN, 05-15-2024 – All MDD certificates are set to expire May 26th, 2024. To continue manufacturing devices after this date with a CE mark, OR to import them into the EEA, devices must either have an MDR certificate OR have an MDD extension per MDR Amendment 2.

“Companies need to track their MDD products currently selling in the European Union and understand that anything restocked after May 26th needs to be MDR compliant.” said Tracy Eberly, CEO of Fang Consulting.

Sell-Off

Within the EEA, MDD products that have already been placed on the market may continue to be sold or put into service indefinitely unless limited by shelf-life/ expiration date. Selling off to countries outside the EEA will depend on the local market requirements and must be assessed individually. Please note that there are countries outside the EEA that also require MDD products to be placed on the market prior to May 26th, 2024.

How to Prepare

• Complete NB MDR applications ASAP for any products you intend to extend for MDD. Submissions must occur by May 26th, 2024, for those devices to be eligible for extension.
• Ensure your supply chain controls will not allow import (including returns) into the EEA of devices with an expired certificate.
• If extending devices using MDR Amendment 2, make sure that countries outside the EEA are aware so they can update their local licenses to take advantage of the extension period.

Contact: 

Tracy Eberly

President & CEO

tracy@fangconsulting.com

612.230.9909

About Fang Consulting

Established in 1999, Fang Consulting provides Regulatory Affairs and Quality Assurance consulting services to medical device manufacturers. From start-ups to global industry leaders, our established presence ensures efficiency, covering both pre-market and post-market device phases. We assist clients in navigating the complex nature of the regulatory landscape. Fang Consulting ensures compliance with medical device laws and regulations in every geography throughout the product lifecycle.

Contact Fang Consulting at 612.230.9909 to learn about how our team can assist your company in navigating Regulatory-related issues.

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See the full press release here.

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The De Novo classification request provides a pathway to classify novel devices (class I or class II) for which general and/or special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.

A predicate must have the same or similar intended use and technological characteristics that do not raise different questions regarding safety and effectiveness. The process has been termed “De Novo” because it requires the agency to evaluate novel devices anew.

There are 2 options to submit a DeNovo request:

• After receiving a not substantially equivalent (NSE) determination was received in response to a 510(k) submission.
• Upon the requestor’s determination that there is no legally marketed predicate device.

De Novo request:

When it is determined there is no legally marketed predicate device, a direct De Novo request can be made without a preceding 510(k) submission and “Not substantially equivalent” determination.   The success of a De Novo request that is filed without a preceding 510(k) or without a Pre-Submission will depend more on how comprehensive a search was conducted for a potential predicate device, clear identification of health risks and special controls (if applicable), and adequate valid scientific evidence to support granting the De Novo request. A Pre-Submission related to a future anticipated De Novo request should contain sufficient information to provide guidance on the test methods and protocols that should be used for the collection of non-clinical and/or clinical data.

De Novo Approval:

If the De Novo request is granted, the new device is authorized to be marketed and must comply with applicable regulatory controls. A new classification regulation for the device type is established and permits the device to serve as a predicate device for future 510(k) submissions. For class II devices, special controls will also be identified.

If the De Novo request is declined, the device remains in class III and the requester may not legally market the device. The requestor will need to submit a new request to pursue marketing authorization for the device.

De Novo Withdrawal:

The FDA considers a De Novo request withdrawn if the requester submits written notice to withdraw, if Additional Information responses or deficiencies are not addressed within 180 calendar days after the date of the request or if the requester does not permit FDA facility inspection and access to records.

Fang Consultants can assist with predicate device searches to support 510(k) submissions or if needed, a De Novo Request.

Source

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-process-evaluation-automatic-class-iii-designation

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A 510(k) is a pre-market submission to the FDA that demonstrates that a medical device is safe and effective, and that it is substantially equivalent to a device that is already legally marketed in the US. Essentially, a manufacturer seeking to market a new or modified medical device submits a 510(k) to the FDA to prove that their device is substantially equivalent to an already approved device, known as a predicate device, that it should also be considered safe and effective for its intended use.

The 510(k) process is named after the section of the Federal Food, Drug, and Cosmetic Act that created it. It is designed to expedite the review of new medical devices by allowing manufacturers to rely on previous FDA determinations of safety and effectiveness for similar devices. This saves time and resources for both the FDA and the manufacturer, while still ensuring the safety and efficacy of new devices entering the market.

For more information on how Fang Consulting can guide you through the complicated 510(k) submission process, or any other medical device regulation needs, contact our team today at (612) 230-9909 or fill out our contact form.

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The COVID-19 pandemic has had a profound impact on public health and the economy worldwide. In response, the US Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) to accelerate the availability of medical products needed to address the pandemic. As the public health emergency declaration approaches its expiration date in the US, it’s important to understand how this impacts EUAs and the availability of medical products.

An EUA is a regulatory mechanism that allows the FDA to authorize the emergency use of medical products during a public health emergency. Under an EUA, medical products can be used for their intended purpose, even if they have not undergone the typical rigorous testing and approval process. The EUA mechanism was used extensively during the COVID-19 pandemic to make medical products, such as vaccines, available to the public in record time.

The public health emergency declaration was first issued in the US on January 31st, 2020, and has been extended several times since then. The current expiration date for the declaration is May 11th, 2023. The expiration of the public health emergency declaration does not mean that all EUAs will be revoked, but it does mean that the FDA will no longer have the authority to issue new EUAs.

Medical products that have already received an EUA will remain available for emergency use, but they will be subject to ongoing review and evaluation by the FDA. This means that any potential safety concerns that arise with EUA products will continue to be closely monitored, and the FDA may take action to modify or revoke the EUA if necessary.

While the expiration of the public health emergency declaration does not automatically revoke existing EUAs, it may impact the availability of some medical products. For example, some manufacturers may choose to discontinue production of products that were only authorized under an EUA once the declaration has expired. This could result in supply chain disruptions and impact the availability of certain medical products.

In conclusion, the expiration of the public health emergency declaration in the US does not mean that all EUAs will be revoked, but it does mean that the FDA will no longer have the authority to issue new EUAs. Medical products that have already received an EUA will remain available for emergency use, but ongoing evaluation and monitoring will continue to ensure their safety and effectiveness. The impact on the availability of medical products will depend on a variety of factors, including the willingness of manufacturers to continue production and ongoing regulatory oversight.

The post Public Health Emergency Expiring: What Will Happen to EUA’s? appeared first on Fang Consulting.

• Premarket Notification (510(k)) submissions
• De Novo requests
• Premarket Approval Applications (PMAs) and PMA supplements
• Product Development Protocols (PDPs)
• Investigational Device Exemption (IDE) submissions
• Humanitarian Device Exemption (HDE) submissions

The release of this guidance has become a topic of controversy, prompting over 1,800 comments expressing concern from the public. Many comments reflect manufacturer concerns, as requirements will be greatly increased to satisfy the QSR, creating a compliance burden throughout the industry. To satisfy these increased requirements, the FDA recommends manufacturers integrate a Secure Product Development Framework (SPDF) into their quality management systems. The SPDF approach has not been seen in this context before, but it seems to reflect the agency’s increased interest in TLPC considerations. The agency expects that manufacturers will perform cybersecurity testing throughout the SPDF. After the device is on market, cybersecurity testing should continue to be performed regularly to ensure continual protection. Though the concept of the SPDF is being introduced through this document, very little information is provided on how it works what exactly is needed to ensure compliance. Software developer BeanStock Ventures commented on this issue, requesting that the FDA provide more information about the SPDF. “Why name a new process, instead of incorporating into the already existing design control processes? The security attributes described in the rest of this draft guidance reference design control process. There is very little explanation for what is SPDF,” the comment stated.

Along with the confusion regarding increased requirements and the introduction of the SPDF, there is also controversy regarding language in the document that many found to be confusing and misleading. A comment from Philips Healthcare states “We urge the FDA to include language around scaling the required/ recommended security processes/ information in accordance with the risk profile of the device… determined be the manufacturer,” as well as “recommendations for medical device manufacturers… need to be made clear what deliverables are requirements and which ones are not… The language within the guidance does include ‘must’, ‘may’, and ‘should’—which certainly suggests requirements.” Philips, along with multiple other healthcare companies such as Fisher & Paykel, expressed a strong desire for the FDA to update the guidance and state in clearer terms what exactly is required from manufacturers in this new submission process. Similarly, many feel that the current draft of the guidance is “repetitive, lengthy, and difficult to read” (BeanStock Ventures). This is not surprising, as the 2022 draft guidance is over five times larger than the 2018 version.

Overall, this controversial change is an interesting development, but certainly not set in stone. The FDA urged the public to comment on the draft guidance until July 7^th, but the flood of comments has not ceased, and will likely lead to an extension of that deadline. Due to the number of issues found by the public, it is likely more changes will be made before anything is finalized. We will continue to investigate and update you on any new developments as they occur.

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By Lily Vucenich  |  July 17, 2022

On July 6^th, 2022, the European Commission released an updated version of the EUDAMED timeline. This version delays important milestones by exactly 1 year, meaning the “full functionality” of EUDAMED is delayed as well. Though the European Commission has stated in the past that EUDAMED is voluntary, Importers can require companies to submit their data in order to continue selling through them. Additionally, after posted transition periods, once “full functionality” is achieved it will be mandatory to submit devices to EUDAMED prior to selling within the European Union.

What does this mean for you?

1. Do not procrastinate. While this extra time might seem like a reason to celebrate, it is not advisable to delay submitting your data to EUDAMED. Given extra time for the industry to prepare for these transitions, it is crucial to not make the mistake of putting off your data preparation and submission.
2. Use the delay to your advantage. The process of gathering and collecting data to meet the standard is longer than one may think. It is important to maintain your momentum and continue to gather proper data, as well as set up a product ID standard.

 

Confusing? We can help you figure it out. Fang Consulting can help your company figure out the complex regulations and data requirements that come with the EUDAMED updates. Contact us at info@fangconsulting.com for a free consultation.

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