FDA Reigns in “Grandfathered” Devices
A new business report called “Cosmetic Surgery Procedures and Products” offers extensive analysis of the cosmetic surgery industries in both America and Europe.
This report was created by Global Industry Analysts, Inc. and is available through researchandmarkets.com, based in Dublin, Ireland. The report examines the two industries a bit differently.
The American market is analyzed in terms of both its cosmetic surgery products and its procedures.
The study range goes back to 2006 and extends through 2015.
It examines the surgical equipment and chemical products that are made available in America, in relation to the cosmetic work that we pay to have done. This continues to include implants, injections, surgeries and skin surfacing.
The European market, on the other hand, is analyzed only in terms of its cosmetic procedures for the years 2008, 2010 and 2013.
The report begins by showing the differences in both industries, and then it ends by showing how they compete.
To create this report, which runs 320 pages, the data was taken from primary and secondary research.
The report also includes profiles of more than 70 companies that are key players in the market, such as Johnson and Johnson, the Mentor Corporation and DermaMed, U.S.A.
In 1976, the FDA began requiring new, high risk, class 3 medical devices to undergo rigorous testing before being made available for use.
Of course, some of these devices were already in use, so they were “grandfathered in” with the understanding that eventually they’d be required to submit the same kind of data required for new devices.
Almost 20 years later, in 1994, the FDA began to follow through on the 149 categories of high risk medical devices.
By 2000, only 82 had not yet been required to submit their data. But today, 27 categories of devices still have not filed the required testing results, and the final deadline is looming. All but two categories must have their data submitted by August 7th of this year.
In addition to heart defibrillators, hip joints and spinal screws, Class 3 devices include breast and pectoral implants.
The devices in question fall into 25 categories, and because new devices are often based off old ones, some products approved just last month may need to undergo an FDA review.