Three Wise Dames

Marketing in the Life Science Industry

Simply Described: FDA Review of Medical Devices March 13, 2013

FDA Logo BetterWhen I learned about the regulatory process that a medical device goes through to get to market, I learned about it on-the-job from experienced medical device communications colleagues, clients and their regulatory counsel.  Since then, I’ve looked for resources to pass on to other teammates or students to explain the process, which can be complex. I’ve found some really good descriptions of the process a drug or biologic undergoes (one of my favorites is by my colleague Mark Senak), but nothing that really works for medical devices.  (If you have a resource, please share it!)

So, here’s what I’ve developed and shared (with the caveat that I am not a regulatory expert.  I have a lot of experience with FDA-regulated products, and I’m offering this from a communications perspective.)

Devices are can go through two different processes at the FDA: The 510(k) and the Premarket Approval (PMA). Every year the FDA reviews thousands of 510(k) submissions, which is about 10 times as many PMA applications.

510(k) Clearance

Approximately 90% of device applications that the FDA receives annually go through the 510(k) process. This is a premarketing submission made to the FDA to demonstrate that the device to be marketed is as safe and effective (substantially equivalent) as a device that is already being legally marketed. This process on average takes under five months, although it can range from three months to about a year. Because it usually requires no clinical trials or research it also requires less investment and presents less financial risk to investors.

However, changes are underway.  The FDA is now requiring some devices going through the 510(k) process to have supporting clinical data, requiring a trial. This is generally the case when there is a new technology or a request for a new indication for use. When a study is required, it is the same as an IDE study (explained below).

Premarket Approval

A PMA is an extensive application submitted to the FDA to request approval to market. Unlike a 510(k), a PMA is based on the FDA’s determination that “there is sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.” (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm)

This process generally takes at least five years, and often longer.  Here’s the process at a glance:

  • Feasibility studies are usually animal studies, and may include other kinds of economic and market research.
  • Investigational Device Exemption (IDE) approval is required from the FDA before in-human trials can begin.  An IDE trial can be a small, pilot or proof of concept study, or it could be a large pivotal trial.
  • In the medical device world, a pivotal trial is considered large when it includes several hundred patients, vs. the several thousand that may be included in a trial for a drug or biologic.
  • All PMAs for a first-of-its kind-device require an advisory committee review.  (I’ve never worked on a project going through the PMA process that didn’t have an advisory committee meeting.)
  • Of the three decisions the FDA can make, two are clear-cut: The device is approved or not approved. An approvable letter is a lot less clear-cut.  It means that the review is complete, but the FDA wants the company to address a few things, such as labeling, or setting up an inspection. When the issues are addressed to the FDA’s satisfaction, then the device may be approved.

Important Lingo

  • The FDA clears 510(k) submissions and products receive 510(k) clearance.
  • The FDA approves PMA applications and products receive FDA approval.

Other Good Resources

Mann Foundation

FDA PMA Overview

FDA 510(k) Overview

WSJ: Too Fast or Too Slow?

This information reflects my experience in working with FDA-regulated products.  Please only use this is a guide, and if you need the final word on matters, talk to your regulatory expert!

©2013 All rights reserved. This article may be shared in part or whole with credit given to author and link to Merryman Communications

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Why my toes are blue with stars March 1, 2013

Colorectal Cancer advocacy

Ready for Colorectal Cancer Awareness month and One Million Strong website kick off

March is colorectal cancer awareness month

Blue is the designated color and stars are the symbol for hope.

Many years ago, the National Colorectal Cancer Round Table (NCCRT) began using the blue star as a unifying emblem for Colorectal Cancer advocacy. Dozens of organizations and thousands of individuals show their support by wearing blue stars in the month of March. As you see events in your communities, I encourage you to participate to raise awareness and get screened. This is the most easily preventable cancer and it is also becoming more survivable even when diagnosed at late stages.

In the US, over 1 million people are survivors of colorectal cancer.

To kick off 2013 festivities, I am in Times Square to support the launch of One Million Strong #1MilStrong a campaign created by Fight Colorectal Cancer. The goal of the campaign is to increase awareness for prevention, screening, treating and beating colorectal cancer. All day we will be spreading the excitement from these activities:

  • Free yoga sessions by Lululemon
  • Dance class/party with James Darling and music by DJ Jay McElfresh
  • Cancer survivor group photo
  • A strong arm pose-off with a visit from WBO Middleweight Champion Peter “Kid Chocolate” Quillin
  • And don’t miss Prevent Cancer‘s Super Colon, an interactive exhibit that offers a close-up look at a healthy (and unhealthy) colon with tips about screening and early prevention

When on the One Million Strong website you can:

  • Make a pledge to be strong, talk to your doctor about screening, be an advocate, urge family and friends to take action
  • Learn more about colorectal cancer advocacy
  • Discover how supporting colorectal cancer organizations improves healthcare for everyone

Fight Colorectal Cancer is one of the leading advocacy groups for this preventable, treatable and beatable cancer. I am proud to be on the team representing:

  • The Colon Club which uses out-of-the-box ways to promote prevention and screening especially for men and women under 50 years old that are symptomatic and/or at risk for developing colorectal cancer. The Colossal Colon and Colondar models will be on tour throughout the year raising awareness in a community near you.
  • Third Eye Colonoscopy which developed the Third Eye Retroscope device to help physicians see behind the folds and flexures in the colon where adenomas (pre-cancerous polyps) like to hide. This breakthrough technology allows physicians to see more of the colon which leads to increased detection of adenomas.

I hope you will follow the fun today on Twitter, FacebookGoogle+, YouTube, Pinterest, and LinkedIn and share with your networks so we can “get behind a cure” in March!

(C) 2013 eGold Solutions; all rights reserved.

 

 
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