Friday, October 7, 2016

QD Syringe | QD Syringe Systems | The Next Generation Low Dead Space Syringe

A New Syringe Designed for greater Dose Control

The patented design of the QD Syringe includes several innovative concepts that also help make it one of the most versatile syringe products available. The QD Syringe consists of a patented cone tip with GlyFlo Technology™ designed as a ready to use draw down needle, eliminating time, needle dulling, hazardous waste and additional inventory ~ Unique bilateral fluid flow channels for easy draw and delivery of viscous liquids ~The QD Syringe is compatible with existing Luer Lock Hubs ~ The QD Syringe has a low dead space mating needle Hub available for up to 20 needle gauge sizes.

For More information contact: Christopher Green at:

Sunday, June 10, 2012

What does it mean when FDA "clears" or "approves" a medical device?

When FDA review is needed prior to marketing a medical device, FDA will either:


  1. "clear" the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or
  2. "approve" the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.

Whether a 510(k) or a PMA application needs to be filed depends on the classification of the medical device.

To acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is "substantially equivalent" to a device that is already legally marketed for the same use.

To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.

 Source ~

Wednesday, June 6, 2012

Is A New 510k Required For A Modification To Your Medical Device?

Is a new 510k required for a modification to the device? 



As described in 21 CFR 807.81(a)(3), a new complete 510(k) application is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device, or the device is to be marketed for a new or different indication.

When a 510(k) holder decides to modify an existing device, the holder must decide whether the proposed device modification(s) requires submission of a 510(k). It is not FDA's intent that a 510(k) must be submitted for every modification. However, all changes in indications for use require the submission of a 510(k). A change in indication for use includes prescription use to over the counter use. Deciding When to Submit a 510(k) for a Change to an Existing Device provides guidance to 510(k) holders on deciding when to submit a 510(k) for a change to an existing device.

Examples of modifications that may require a 510(k) submission include, but are not limited to, the following:
  • Sterilization method
  • Structural material
  • Manufacturing method
  • Operating parameters or conditions for use
  • Patient or user safety features
  • Sterile barrier packaging material
  • Stability or expiration claims
  • Design
FDA believes that the 510(k) holder is best qualified to determine when modifications to their device could significantly affect safety or effectiveness. Therefore, every modification to the device should be reviewed by appropriate personnel to determine if it affects safety or efficacy. Any design or labeling change to a device should be evaluated and documented in accordance with the 21 CFR 820, Quality System regulation. If it is determined that the modification is not significant, the basis for this decision should be documented with supporting data in the 510(k) holder's device master file. If it is determined that the modification is significant, a new 510(k) must be submitted to FDA.

There are no provisions for a 510(k) amendment or supplement to the existing 510(k). A new 510(k) must be submitted. However, FDA developed a streamlined 510(k) process for modifications to a device cleared under 510(k), called the Special 510(k).

 Source ~