Regulatory Focus™ > News Articles > New 510(k) Pilot Program Aims to Take the Frustration out of Submissions

New 510(k) Pilot Program Aims to Take the Frustration out of Submissions

Posted 01 May 2014 | By Alexander Gaffney, RAC 

Each year in the US, millions of Americans choose to utilize the services of an online tax preparation service like TurboTax, H&R Block, TaxACT and others. The Internal Revenue Service (IRS) has also gotten into the business of making it easier to file with its own Free File Software, available to consumers making less than a certain income.

Despite its cost, the software is popular because it makes filing taxes-ordinarily a time-consuming, confusing and otherwise difficult task-relatively easy. Consumers of the product enter information based on simple questions, and that information is then automatically formatted by the programs and submitted to the IRS electronically.

Now the US Food and Drug Administration (FDA) appears poised to rip a page from the IRS handbook in the hopes of making it easier for medical device manufacturers and sponsors to submit product applications to it electronically with the help of a new program.

New Pilot Program

As explained by FDA, its new 510(k) eSubmissions Program will help guide companies through the construction and submission of a premarket notification [510(k)] application, "eliminating the need for a hard copy or a compact disk."

The hope, FDA said, is that the program will be able to increase adherence and compliance with its various regulatory requirements and recommendations. The "guided interface" will have several features to "ensure appropriate regulatory submission standards and recommendations are met or considered," FDA said in a Federal Register notice announcing the program.

The net benefit to both FDA and industry should be more compliant 510(k) submissions and less time-consuming application submissions and reviews.

Who Can Participate?

For now, the program will only accept unbundled, traditional 510(k) submissions for classified devices -not third party 510(k)s or combination products, FDA said.

The program is set to start under a pilot phase available to a "limited" number of interested sponsors whose products are reviewed by the Office of Device Evaluation's (ODE) Division of Cardiovascular Devices Cardiac Diagnostic Devices Branch or Peripheral Interventional Devices Branch.

Devices reviewed by those branches include:

  • blood pressure monitors
  • implantable hemodynamic electrophysiology monitors
  • arrhythmia detectors
  • electrocardiograms
  • multiparameter monitors
  • diagnostic computers
  • external defibrillation devices
  • diagnostic catheters
  • stents
  • atherectomy catheters
  • embolic protection devices
  • angioplasty catheters
  • embolectomy catheters
  • guidewires, introducers, guide/support/infusion catheters

Other Details

The pilot program will remain open for new submissions through 30 September 2014, though FDA said it's possible it may close sooner or later than that depending on its resources and needs for the program. Between 50 and 100 submissions will be accepted.

The agency has also released a user guide for the program. The program itself is available for download on FDA's website.

If the pilot program goes well, other types of devices may soon be allowed to participate, FDA said.


FDA Statement

Federal Register Announcement


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