US FDA has stringent regulations for medical devices entering the US market. For launching a new medical device in US, you need to mandatorily comply with all FDA medical device regulatory guidelines. Additionally, you need to secure the applicable approval type for your device. In this blog, we have discussed FDA regulatory pathways for new medical devices.
US FDA classification for medical devices
An understanding of the US FDA medical device classification system will help determine the FDA regulatory pathways for new medical devices. The US FDA medical device classification system is based on the level of risk the devices pose to patients and users. The medical devices have been broadly categorised into three classes:
- Class-I: Class-I devices pose minimal risk to patients and users and are simple in design. Examples: Bandages, tongue depressors, etc.
- Class-II: Class-II devices are moderate risk devices. They require more regulatory control to ensure safety and effectiveness. Examples: Infusion pumps, powered wheelchairs, etc.
- Class-III: Class-III devices are high risk devices that support or sustain life. They are required to prevent significant health impairment or present a potential risk of illness or injury. Examples: Pacemakers, heart valves, etc.
FDA regulatory pathways for new medical devices: In case of predicate device availability
When deciding on which regulatory pathway to follow, check whether your medical device has a predicate device. A predicate device is a legally marketed device that is similar to the new device in terms of technology, intended use, and labelling. Availability of a predicate device will determine the applicable FDA regulatory pathways for new medical devices. The applicant may choose 510(k) premarket notification for the new device. Notably, US FDA 510(k) covers low-risk Class I and II medical devices. Moreover, the process is less rigorous and cumbersome. The applicant is required to demonstrate the new device is substantially equivalent to a legally marketed predicate device. The application should be used to prove the new device is as safe and effective as the predicate device. Additionally, the new device’s features, including labeling, indications for use, and technological characteristics, should be similar.
The FDA will review the application. If the authorities feel the device is substantially equivalent to the predicate, they will clear the device for marketing without the need for additional clinical data.
FDA regulatory pathways for new medical devices: In absence of predicate device
In absence of predicate device, there are two FDA regulatory pathways for new medical devices. The applicable pathways will depend on the device class.
The de novo pathway:
For medical devices having no predicate device and are low to moderate in risk, De Novo classification process can be the best option. The De Novo pathway is the viable regulatory route for innovative devices posing minimal risk to patients. Moreover, the device should not fall in any existing classification regulation. The medical device manufacturer will have to file a De Novo application. Additionally, the probable risks and benefits of the device as well as how to mitigate risks using general and special controls have to be mentioned. FDA authorities will review the safety and effectiveness of the medical device based on clinical data and performance testing. Once satisfied, the FDA assigns the device a classification.
Once the De Novo is granted, the medical device can be marketed immediately. The classification will be published in the Federal Register. Additionally, the controls necessary to provide reasonable assurance of safety and effectiveness will be mentioned. The De Novo route is typically faster and less expensive than the pre-market approval (PMA) pathway. Furthermore, once the De Novo is granted, the device will be permitted to serve as a predicate for future 510(k) applications. If the De Novo Pathway application is rejected, the device cannot be marketed without further efforts by the applicant and acceptance by FDA.
Pre-market approval (PMA):
High-risk devices and those that do not qualify for the De Novo pathway will require pre-market approval (PMA). The PMA is a rigorous and comprehensive FDA review process evaluating the safety and effectiveness of the device. Medical device manufacturers are required to submit comprehensive data, including results from clinical trials, to the FDA for review. PMA is a stringent regulatory pathway. It requires extensive clinical and scientific evidence to demonstrate the device is safe, effective, and of high-quality.
Devices covered: Any Class III or high-risk devices that cannot be covered by 510(k) clearance or De Novo pathway requires PMA. To find out whether your medical device requires a PMA, use the three-letter product code to search the database. The product code is a short identifier indicating the type of device being made and its intended use.
The PMA application review usually takes 180 days. The timeline can vary depending on the complexity of the device and the quality of the data and evidence submitted. The PMA is particularly essential for high-risk devices that require thorough screening and evaluation for patient safety. Hence, the PMA can be time-consuming and costly.
Requirements for premarket approval (PMA)
- A PMA submission is required to have an in-depth description of the device and its intended use. Additionally, details about the device’s manufacturing processes, facilities, and controls will be required.
- Properties relevant to the disease or condition to be treated have to be mentioned. Additionally, a list of functional components and the methods of development have to be provided.
- An explanation of the device’s unique features and how it will address a specific medical need has to be mentioned.
- Clinical trial data, including study design, patient demographics, and statistical analysis, have to be provided.
- Laboratory test results demonstrating the device’s performance, biocompatibility, safety, and functionality.
- A robust quality management system (QMS)
- A thorough assessment of potential hazards associated with the medical device and plans to mitigate those risks.
- Proposed labels for the device, including instructions for use, safety warnings, and any other necessary warnings.
- A proposed post market surveillance plan for monitoring the device’s performance and safety after it is marketed.
- Compliance with good manufacturing practices (GMP)
The PMA submission has to be written carefully per guidelines and should be well structured. It should be complete, accurate, consistent, and include critical information. Moreover, it should be well organized for a quick approval. The PMA requirements are extensive and elaborate. We have provided an overview. For a detailed list of requirements, feel free to contact us. Only after thoroughly reviewing the data and the application, the FDA authorities will grant the PMA.
Pre-submission meetings: An invaluable opportunity for medical device manufacturers
The FDA regulatory pathways for new medical devices can be complex and confusing. However, the agency is highly supportive of manufacturers and applicants. It encourages open dialogue throughout the submission process. Pre-submission meeting is an invaluable opportunity for manufacturers to clarify their doubt. They can discuss their device and proposed regulatory pathway directly with the FDA, gain clarity on FDA expectations, and receive feedback on their regulatory strategy. Additionally, they can get their potential concerns clarified before submitting their formal application. Thus, by attending pre-submission meetings, manufacturers can significantly improve their chances of successful and timely FDA approval.
Pharmadocx Consultants: Your trusted consultant for navigating FDA regulatory pathways for new medical devices
All medical devices entering the US market must comply with the regulatory requirements formulated by US FDA. These regulatory requirements are in place to ensure safe, effective, and high-quality medical devices reach the patients. The regulatory pathway required will depend on various factors. Hence, navigating the US FDA regulatory pathways can be confusing. FDA has different regulatory pathways for new medical devices. Zeroing in on the correct regulatory pathway can be overwhelming. Email at [email protected] or call/Whatsapp on 9996859227 for a smooth US FDA regulatory journey.
