Refuse to Accept Policy

Refuse To Accept outlines the basis on which the FDA decides whether a 510(k) submission meets required acceptability standards and if it should be further considered for a substantive review. I...

Intended use and indications for use

There is always some uncertainty when it comes to distinguishing between intended use and indications for use. Most people often interchange the terms during usage. We have made a concise table ...

eCopy

eCopy(electronic copy) is done as a part of submission package for CDRH (Centre for Devices and Radiological Health).

It is an essential part of:

510(k)De novoPMA (Pre market appro...

510(k) flowchart

FDA has laid out characteristics essential for the review of 510(k) submission. It is important to be aware of the following flowchart before the actual submission is made :

Source: FDA g...

510(k)

510(k) is a pre-market submission filed at the FDA by the manufacturer who intends on  releasing a medical device into the market. A 510(k) basically demonstrates that the device to be mark...

PMA Submission

Medical devices that have a high risk associated with them require a pre-market approval (PMA). A PMA is a detailed document that requires clinical data to substantiate the claims made for a par...

Wearables

Elexes often provide start-to-finish regulatory and quality services to clients. One such example is a start-up that was developing a novel wearable device to monitor vital signs.The company nee...

Active devices

A medical device company asked Elexes to prepare a regulatory strategy for an active device. The goal was to bring their product into the US and European markets by complying with all applicable...

Invasive Devices

At Elexes, we have assisted companies that already have FDA clearance for a particular medical device and want to make changes to this existing device to meet their users’ needs, serve a new pat...

Food and Cosmetics

Elexes has created numerous supplement fact sheets for dietary supplements, the nutritional label for foods, and has also reviewed labels of cosmetic products to make sure that there are no drug...