December 1, 2011

Cover Story

Best Companies To Work For

What makes a business a Best Company to Work For? Is it by offering a robu...Read More

Featured Articles

2012 Economic Forecast

A Friend in Need

Sections

Around Utah
Around Utah

Lessons Learned
Change Agent

Focus
Custom Made Employees

Economic Insight
Economic River Rafting

Industry Outlook
Entrepreneur

Legal Briefs
LLC Update

Executive Living
Natural History Museum of Utah

EntrepreneurEdge
Rising Up the Ranks

Regional Report
Southern Utah

TechKnowledge
Step by Step

Editor's Note
Utah Ranks No. 1 Again

Money Talk
Why Aren’t Banks Lending?

Spotlight
Con Wadsworth

Spotlight
Mark Tuffin

Players
Players

Article

Step by Step

The FDA Keeps a Watchful Eye on the Medical Device Industry

Spencer Sutherland

December 1, 2011

Each year, thousands of new medical devices enter the commercial market. But before any of these products land on the shelf, they must pass through the gatekeeper—the U.S. Food and Drug Administration. Though the FDA’s approval process can be complicated, timely and often expensive, there are a few things that can simplify the experience.

The FDA Classification System

Having spent more than 25 years in the medical device industry, Stephanie Erskine is no stranger to the nuances of working with the FDA. “The FDA’s mission is to protect public health,” says Erskine, who has served as chief regulatory affairs officer at Merit Medical for nearly a decade.

“If I’m developing a device, I have to first look at its class within the FDA classification scheme,” Erskine says. “That [classification] will drive the regulatory process to either clear a device for market or get the device approved for market.”

The FDA has established three classes of medical devices, based on the level of regulatory control required to assure the product’s safety and effectiveness.

Class I devices—those subject to general controls, such as drainage catheters, occlusive wound dressings and scalpels—pose the least risk to users and are thus the least burdensome to bring to market.

Though Class I devices must be listed with the FDA, they generally do not need to go through the agency’s review process. For these devices, “a manufacturer takes complete responsibility for manufacturing the device in accordance with the quality system regulations,” Erskine explains. Once the requirements have been met, the manufacturer is free to launch the product.

Clearance for a Class II device—such as a diagnostic catheter, guide wire or vascular introducer—is a bit more complicated. These products are required to go through the FDA’s pre-market notification review process. To do so, a manufacturer must complete a pre-market notification submission [510(k)] that contains data demonstrating the device’s safety and effectiveness. Some Class II devices also require human clinical trials.

A new Class II device will also be cleared if the manufacturer can show that it is “substantially equivalent” to a device that is already on the market. The FDA has 90 days to review a manufacturer’s 510(k), but recent changes at the agency have resulted in this process often taking much longer.

The Rigorous Approval Process

“Class III devices involve a much more rigorous process,” Erskine says. Devices in this category, including those that support or sustain life, pose serious potential risks, or that need added control measures to demonstrate safety and effectiveness, require more oversight from the FDA.

Whereas a Class I device must only be listed with the FDA, and a Class II device must be cleared by the FDA, a Class III device must be approved by the FDA.

“Generally speaking, human clinical studies are required for Class III devices in order to demonstrate their safety and effectiveness,” Erskine says. Her company is currently conducting a human clinical trial for a Class III device, an embolic for the treatment of hepatocellular carcinoma.

The manufacturer is responsible to develop the clinical trial protocol, which must then be approved by the FDA. “There is usually a lot of back and forth before both parties come to an agreement on exactly what the trial size will be, how many patients will be enrolled, whether it needs to be multi-center or single site, etc.,” Erskine says. “The negotiation process can take quite a while.”

Though the FDA does not oversee the actual clinical trials, it may conduct audits to make sure all regulations are being followed. After the trials have been completed, the manufacturer’s test and clinical data are reviewed by the FDA. If the data demonstrate the device’s safety and effectiveness, the agency will approve the device for marketing.

A Changing Regulatory Landscape

Beyond the rigors of the complicated applications and clinical trials, manufacturers must also be willing to ride the tides of a changing FDA.

“The most challenging part of working with [the FDA] is that it’s a moving target,” Erskine says. In addition to substantial turnover within the agency, the FDA frequently releases new guidance documents, changes direction on several different topics, and reevaluates the 510(k) process.

“Sometimes the agency will have a change in their thinking or in their way of reviewing a device that goes above and beyond what they have published in guidance documents,” she adds. “That makes it even more critical to engage them in discussions prior to our submissions.”

Though review time has a tendency to lag, Erskine says the pace at which new medical products are being developed is rapidly accelerating. “We fully believe in expanding our product offering to better meet practitioners’ needs in the markets we serve,” Erskine says of Merit Medical, which shows no signs of slowing down.

Utah Business Social
UB Events View All
Health Care HeroesUtah Business Event
Oct 21, 2014
Please join us, along with our sponsors, MountainStar Healthcare, and Roseman University in honor...
Content Marketing BootcampUtah Business Event
Oct 28, 2014
Please join Utah Business Magazine and Adobe, along with our other sponsors: Boostability, Right ...
Sustainable Business Awards 2014Utah Business Event
Nov 13, 2014
Utah Business magazine along with presenting sponsor Big D Construction, is pleased to announce t...
Community Events View All
St. George Book Festival - Author Appearances
Oct 21, 2014
Free to the Public Locations: Washington County Schools, Bookstores, Libraries & St. George C...
InDesign Level 1
Oct 21, 2014
Come see why InDesign is gaining popularity in the desktop publishing world. In this 14-hour, int...

info@utahbusiness.com  |  90 South 400 West, Ste 650 Salt Lake City, Utah 84101   |  (801) 568-0114

Advertise with Utah Business

Submit an Event

* indicates required information
* Event Name:
Price (general):
Website (if applicable):
Coordinator's Name:
Coordinator's Email:
Coordinator's Phone:
Venue Name:
Venue Address:
Venue City:
Venue Zip:
Event Capacity:
Date(s):
to
* Event Description:
  Cancel