Monday, October 12, 2009 1:57:11 PM
http://www.massdevice.com/news/industry-leaders-express-concern-fda-clamps-down-510ks
September 30, 2009 by MassDevice staffAn internal memo leaked by the <em>Wall Street Journal</em> indicates that the Food & Drug Administration intends to make its 510(k) approval process for medical devices even more stringent, prompting alarm from industry leaders.
An internal Food & Drug Administration memo leaked by the Wall Street Journal indicating that the Food & Drug Administration plans to tighten up its 510(k) approval process for medical devices has industry leaders expressing concern.
According to the memo, written by FDA device evaluation office head Donna-Bea Tillman, the agency is already clamping down on the 510(k) process, by which the majority of medical devices are approved.
"It's Autumn, and change is in the air. This is particularly true for our 510k program," Tillman wrote, according to the Journal, adding that in order to "get a better lay of the land" branch chiefs are now required to pass along applications for devices with a new "indication" or use "that you have never cleared for that device type."
That's a deviation from former FDA protocol, two FDA scientists told the newspaper. But new protocol is "just the first of what I am sure will be many things that we will be doing to strengthen the 510k and all of our other programs in the months ahead," Tillman wrote.
Thomas Sommer, president of MassMEDIC, the Massachusetts medical device industry council, told MassDevice that the 510(k) procedure, which is used for devices that are "substantially equivalent" to products already on the market, is one of the world's most stringent approval processes.
"Our concern as an industry is that this change in protocol will bring us back to the days in the mid-1990s when 510(k)s took well over a year for FDA to clear," Sommer told us. "This industry is one of the most heavily regulated industries. It complies with FDA guidelines and regulations on everything from developing products to manufacturing to marketing and sales. Companies do a very good job of complying with a vast web of regulations.
"Our companies already comply with the toughest product review protocol in the world. It's viewed as the gold standard and most companies are delighted to go though the process, because it means they have achieved the highest certification of safety and effectiveness in the world."
A Johnson & Johnson spokeswoman sounded a similar note in speaking with the Journal, saying that adding evidentiary requirements to the 510(k) process "would raise development costs substantially while also creating barriers to market entry that would reduce competition."
The FDA, in addition to its own internal review of the process, commissioned the Institute of Medicine for a $1.3 million study examining whether the 510(k) process protects patients and promotes innovation and what changes, if any, are needed.
Another closely watched issue is a proposed 10-year, $40 billion tax on medical device makers included as part of the healthcare reform push in Washington. The national medical device industry council, AdvaMed, issued a study today claiming that the proposal would double the industry's existing tax burden.
The study, by Robert Carroll, former U.S. Treasury Dept. tax analyst and Tax Foundation senior fellow, found that the proposed tax would increase the medical device industry's tax rate from 23 percent to nearly 50 percent.
That, in turn, is likely to shift innovation overseas, according to the report, and could also drive up healthcare costs as the tax increase is passed on to medical device firms' customers.
Its most onerous impact would be on fledgling device firms that aren't yet showing a profit, AdvaMed president and CEO Stephen Ubl said in a statement. That's because nearly 3,000 device makers with no profits would be due to pay a total of $600 million in annual taxes under the proposal, according to the study.
Recent TENX News
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 09/27/2024 12:14:24 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 09/13/2024 04:15:07 AM
- Form SC 13G - Statement of Beneficial Ownership by Certain Investors • Edgar (US Regulatory) • 09/10/2024 09:19:47 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 08/30/2024 08:20:02 PM
- Form SC 13G - Statement of Beneficial Ownership by Certain Investors • Edgar (US Regulatory) • 08/19/2024 10:48:03 PM
- Form SC 13G - Statement of Beneficial Ownership by Certain Investors • Edgar (US Regulatory) • 08/19/2024 08:15:15 PM
- Form SC 13G - Statement of Beneficial Ownership by Certain Investors • Edgar (US Regulatory) • 08/15/2024 08:19:12 PM
- Form SC 13G - Statement of Beneficial Ownership by Certain Investors • Edgar (US Regulatory) • 08/14/2024 10:47:35 PM
- Form SC 13G - Statement of Beneficial Ownership by Certain Investors • Edgar (US Regulatory) • 08/14/2024 07:19:24 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2024 08:45:45 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/13/2024 08:30:22 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/12/2024 12:35:42 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/08/2024 11:43:25 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/08/2024 11:42:23 PM
- Biotech Soars Following Oversubscribed $100M Private Placement Announcement • AllPennyStocks.com • 08/06/2024 08:55:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/06/2024 11:23:52 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/13/2024 08:32:09 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/21/2024 09:01:41 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/21/2024 09:00:50 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/14/2024 08:01:36 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/14/2024 01:01:43 PM
FEATURED Element79 Gold Corp. Reports Significant Progress in Community Relations and Development Efforts in Chachas, Peru • Oct 9, 2024 10:30 AM
Unitronix Corp Launches Share Buyback Initiative • UTRX • Oct 9, 2024 9:10 AM
BASANITE INDUSTRIES, LLC RECEIVES U.S. PATENT FOR ITS BASAFLEX™ BASALT FIBER COMPOSITE REBAR AND METHOD OF MANUFACTURING • BASA • Oct 9, 2024 7:30 AM
BNCM COMPLETES MERGER WITH DELEX HEALTHCARE • BNCM • Oct 8, 2024 9:54 AM
CBD Life Sciences, Inc. (CBDL) Reaches Unprecedented Heights With Explosive Growth and Strategic Expansion in 2024 • CBDL • Oct 8, 2024 8:00 AM
Unitronix Corp. to Invest $3 Million in USA Unity Coin Project • UTRX • Oct 7, 2024 7:08 AM