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HINJ Testifies Before FDA on Need for Additional 510(k) Premarket Notifications

Silver Spring, MD, June 14, 2013 — HealthCare Institute of New Jersey (HINJ) President and Chief Executive Officer Dean J. Paranicas on Thursday delivered the following testimony at a meeting of the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) relating to “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.”

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I am Dean Paranicas, President and Chief Executive Officer of the HealthCare Institute of New Jersey (or HINJ).  On behalf of HINJ, I appreciate the opportunity to offer testimony today to the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on the subject of “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.”

HINJ is a trade association for the research-based biopharmaceutical and medical technology industry in New Jersey, which is a key driver of New Jersey’s economy.  HINJ serves as a unified voice for the industry and seeks to:

  • Advocate for policies and legislation that protects patient access to medicines, medical technologies and devices; and
  • Foster an innovation environment — both in New Jersey and nationally — that allows life sciences companies to research and bring to market the next generation of treatments and cures for the world’s patient community.

HINJ member companies directly employ over 51,000 people in New Jersey and are responsible for an additional 60,000 indirect jobs, and generate a total annual economic impact to New Jersey of over $24 billion.  Life sciences are the largest industry sector in our state.

There are currently 25 members of HINJ; our medical technology member companies include Abbott Point of Care, Inc.; BD; C.R. Bard, Inc.; Johnson & Johnson; Novo Nordisk, Inc.; and Stryker Corporation, all of which also are members of the Advanced Medical Technology Association (or AdvaMed), which has submitted materials on the subject matter of today’s hearing.

The views I express today on behalf of HINJ are closely aligned with those of AdvaMed, and the views expressed today by me on behalf of HINJ supplement those expressed by AdvaMed in its submission on the subject of today’s hearing.

We at HINJ recognize the importance of the 510(k) process as a critical component of FDA’s premarket review and clearance of medical devices. 

With respect to changes to existing devices already on the market, we agree with AdvaMed that manufacturers are indeed best situated to make initial submission determinations for device changes that “could significantly affect the safety or effectiveness” of a device in accordance with established procedures, and that not all changes of a type necessarily require new 510(k)s.

HINJ therefore supports AdvaMed’s view that the Agency’s 1997 guidance document, together with the Quality Systems Regulation (or QSR) issued in 1996, as revised by AdvaMed’s recommended modifications, should continue to be the appropriate foundation for determining when a premarket notification should be submitted for a modification or change to a legally marketed device. 

As no single type of change should be identified as always requiring or not requiring a new premarket notification, through substantial reliance on the QSR, each manufacturer should evaluate a device change through established procedures.

We believe this approach would strike the right balance and maintain the necessary direction and flexibility so that modifications are adequately assessed, and, when appropriate, submitted to the Agency.

The improvements to the 1997 guidance document recommended by AdvaMed calling for explicit requirements for manufacturers’ evaluation of changes, record-keeping of such changes and validation or verification testing, would reinforce confidence in the determinations of manufacturers regarding the need to submit premarket notifications for changes. 

This approach would provide the Agency with the necessary assurance that FDA-sanctioned processes are being followed and appropriately documented for these purposes, and preserve the Agency’s remedies where they may be required.

The 510(k) process is a key component of medical progress.  HINJ and AdvaMed believe it can be further strengthened in the ways I have described to support continued innovation, which is the lifeblood of the life sciences, while at the same time ensuring that patients have timely access to safe and effective devices and technologies.

HINJ commends FDA’s continued commitment to an open, public dialogue on these issues.  Thank you for your consideration of my comments today.