FDA creates medical device development tool program to speed up evaluation, approval process — 4 insights

The FDA created its voluntary Medical Device Development Tools program to help speed up the medical device evaluation and approval processes.

Here's what you should know:

1. Through the new program, developers can submit a tool for consideration. The FDA can decide whether to "qualify" it. FDA qualification means a device functions as described and does so accurately.

2. The FDA announced it would only qualify tools if there's a high level of publically available information, so the device development community will have an understanding of the device's potential benefits beforehand.

3. The FDA believes qualified tools speed up medical device development by reducing reliance on animal testing as well as minimizing test duration or necessary sample size.

4. The FDA is offering the qualification for three types of tools:

  • Clinical outcome assessment tools
  • Biomarker tests
  • Nonclinical assessment models

For more information on the qualification process, click here.

More articles on supply chain:
Hurricanes Irma, Maria could create medical device shortages — 6 insights
Dr. M. Jonathan Worsey earns national supply chain award — 4 insights
Holy Name Medical Center taps CareCloud for 35 ambulatory practices — 3 key notes

© Copyright ASC COMMUNICATIONS 2017. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

 

Top 40 Articles from the Past 6 Months