Ways tomake your medical device available in the US market

 

Medical devices marketedin the US market are subject to the regulatory controls ofthe Federal Food, Drug, and Cosmetic Act (FD&C Act) and additionally the laws in Title 21 - Code of Federal laws (21 CFR) elements 1-58, 800-1299. The regulatory controls and commerce pathwayshelp assess the risk posed bythe device and are needed for assurance of safety and effectiveness of the medical devices. The regulatory pathways include: Premarket Notification (510(k)), Novo Classification Request, Exempt, Premarket Approval (PMA), development Protocol (PDP), Humanitarian Use Exemption (HDE), and Biologics License Application (BLA).

Broadly, the steps to bring a device to the market can be covered in three steps:

1.        Classify the device

2.        Select the appropriate regulatory pathway

3.        Establishment registration and device listing

Classification of devices

The regulatory pathway for each device varies based on the complexity of the device and the risk posed by the device. The US FDA has a risk-based classification system for medical devices. Accordingly, medical devices are classified as:

Ø  Class I or low risk device

Ø  Class II or medium risk device

Ø  Class III or high-risk device

This classification of devices is made based on the intended use and indications for use.

Selection of the regulatory pathway

There are different pathways available to medical device manufacturers to place their devices in the US market.

510(k) Clearance (Pre-Market Notification)

Majority of the Class II devices and some of the Class I devices are cleared for sale in the US via the pre-market notification pathway. In a 510(k) submission, manufacturer is required to compile and submit evidence demonstrating the safety and effectiveness of the proposed device by proving substantial equivalence to a predicate device. Under the 510(k)-notification pathway, predicate device is a legally marketed device already cleared by US FDA for sale in the US. 510(k) dossier compilation includes documenting the similarities and difference between the proposed device and the predicate device. FDA takes anything between 30 and 90 days for processing a 510(k) application.

Premarket Approval (PMA)

Class III devices generally are brought to the US market via the pre-market approval pathway. Other devices with no predicate device also general employ the PMA pathway. One of the highlights of the PMA pathway is the need for good evidence proving safety and effectiveness of the proposed device which is generally collated from a clinical trial. FDA generally takes 180 days to process a PMA application.

De Novo Request

The De Novo pathway is good alternate for novel device of significantly lower risk for which a suitable predicate may not be available. However, manufacturer must ensure that the risks associated with the proposed device between low to moderate and is adequately mitigated through risk control. The typical turnaround time from FDA for De Novo is around 120 days. 

Humanitarian Device Exemption (HDE)

A Humanitarian Device Exemption pathway is applicable for devices that are developed to treat or diagnose conditions that affects small or rare populations -fewer than 4000 individuals in the US per year. FDA states that for a device to be considered as a humanitarian use device, other comparable devices with the same intended use must not be available on the market. US FDA takes around 75 days to review the HDE application. The submission contents are similar to that required for a PMA submission with the exception of data from clinical investigations.

Custom Device Exemption (CDE)

Any device customized to meet the needs of a specific patient will be subjected to the custom device exemption pathway. Such devices are exempt from 510(k) or PMA submissions but must comply with other requirements including:

·         Design Controls (21 CFR Part 820)

·         Medical Device Reporting (21 CFR Part 803)

·         Labeling (21 CFR Part 801)

·         Corrections and Removals (21 CFR Part 806)

·         Registration and Listing (21 CFR Part 807)

 

Other processes from US FDA to enable regulatory planning for medical devices

Q-Submission process

US FDA enables discussions with them to help manufacturers explore the different regulatory pathways available to them for bringing their device to the market. The guidance for the Q-submission program lists out the different way’s manufacturers can approach US FDA for feedback or meetings with US FDA.

Investigational Device Exemption (IDE) pathway

This pathway is for medical device prototypes which are subjected to controlled studies to collect clinical data to demonstrate safety and effectiveness.

Emergency Use Authorization (EUA)

Emergency Use Authorization may be initiated by US FDA to fulfil any emergency need as determined by US FDA.