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 the risk associated with the device. Hence, it is vital to classify the medical device properly. Furthermore, understanding the difference between FDA 510(k) and PMA is vital. These two regulatory pathways are applicable to different classes of devices. Additionally, their process, document required, associated costs, and effort required vary. Hence, our blog on FDA 510(k) vs PMA will highlight the difference in their scope, applicable device type, and process.
FDA 510(k) vs PMA: A brief overview
Both FDA 510(k) and PMA are FDA regulatory approval pathways for medical devices entering the US market. However, there is considerable difference between FDA 510(k) and PMA, which medical device companies should be aware of. We have highlighted the major differences between FDA 510(k) and PMA.
FDA 510(k) clearance process is a less rigorous process used for approval of medium-risk medical devices, such as Class I and II devices. This process is used for devices having a predicate device. The 510(k) clearance process is usually faster than PMA.
On the other hand, premarket approval (PMA) is rigorous and comprehensive meant for medical devices with higher risk, Class III or above. Additionally, PMA is used for medical devices that are novel and have no predicate device. The time required for PMA is considerably longer than that of 510(k) clearance.
What is the difference between FDA 510(k) and PMA?
We have discussed in-depth the difference between FDA 510(k) and PMA with respect to devices covered, requirements, and process.
What is US FDA 510(k)?
US FDA 510(k) is a premarket notification process used to demonstrate the device in question is as safe and effective as the “substantially equivalent” device being sold legally in the US. This process involves evaluating and comparing the device with the “substantially equivalent” device already being sold in the US market. This similar product or “substantially equivalent” device is known as a predicate device. The 3 types of US FDA 510(k) are as follows:
- Traditional 510(k): This is the original 510(k) and can be used in any situation.
- Special FDA 510(k): This type of FDA 510(k) is required when there is a modification in the device but the modification will not impact the intended use of the device.
- Abbreviated FDA 510(k): When the submission is based on FDA guidance documents, demonstrates compliance with special controls for device type, or follows a voluntary consensus standard.
Devices covered
US FDA 510(k) covers low-risk Class I and II medical devices. These devices must have a substantially equivalent predicate device. Furthermore, if a significant change is introduced to a legally marketed device, a US FDA 510(k) premarket notification will be required. A modification that could substantially affect the device’s safety, effectiveness, or intended use will be considered a “significant change”. Moreover, domestic medical device and IVD manufacturers who are trying to introduce new devices to the US market will have to secure the FDA 510(k) clearance. Additionally, re-labellers or re-packers who make device labelling changes will also require this clearance.
Requirements for 510(k) clearance
The following basic information will be required for securing 510(k) clearance:
- The device’s name
- The device classification
- Actions taken to abide by performance standards
- Location the device will be launched in the market
- A comparison with other similar devices
- A financial certification
- Clinical trial data, if applicable
- Potential ideas for labels and advertisements that will properly demonstrate the device’s use
US FDA 510(k) process
US FDA 510(k) is a premarket notification having a specific format. The progress 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.
The US FDA 510(k) submission must be sent to the appropriate FDA centre. The regulatory officials will validate the comparison providing evidence for substantial equivalence claims. Until the applicant has received a response from the FDA confirming their device’s clearance, they are not permitted to market their device.
What is premarket approval (PMA)?
As per FDA classification, Class III medical devices are devices that can “support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.” Hence, all devices belonging to Class III or higher risk level require a premarket approval (PMA) because of the effect they have on human life. A rigorous and comprehensive FDA review process evaluating the safety and effectiveness of the device is conducted. Only after successful review of the device the PMA is granted.
Devices covered
Any Class III or higher risk device that cannot be covered by 510(k) clearance 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.
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.
- Compliance with good manufacturing practices (GMP)
- Clinical trial data, including study design, patient demographics, and statistical analysis.
- 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.
The PMA requirements are extensive and elaborate. We have provided an overview. For a detailed list of requirements, feel free to contact us.
Premarket approval process
The PMA application is usually submitted by an individual, corporation, government agency, etc. having access to the data and information about regulatory controls. The application must include administrative elements as well as scientific and clinical data for review and approval by the FDA. 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.
FDA 510(k) and PMA: Key differences
- FDA 510(k): An FDA 510(k) submission is used to provide the FDA with documented evidence proving the medical device in question is substantially equivalent to a predicate device. An FDA 510(k) clearance usually requires 90 days and is a relatively less rigorous process. It is less costly and results only in FDA “clearance.”
- PMA: A premarket approval (PMA) is more in-depth and comprehensive than FDA 510(k) submission. PMA is used to prove a new device is safe and effective using data obtained from clinical trials with human participants. The approval process requires 180 days. It is reserved mainly for high-risk devices. A PMA application has a more extensive approach and is more expensive than FDA 510(k). As PMA requires substantial evidence that the device is safe and effective, it results in FDA “approval”.
Navigating the US FDA 510(k) and PMA regulatory pathways can be a tough task. Simply email at [email protected] or call/Whatsapp on 9996859227 and we will reach out to you. With our support, your application has very high chances of swift and hassle-free approval.
