The Advanced Medical Technology Assn. said it is "generally pleased" with what it saw from the Food & Drug Administration’s proposed plan to re-vamp the process by which a majority of medical devices are cleared for market but warned that the proof is in the pudding.
Cautiously optimistic was the word from LifeScience Alley after the FDA released details Wednesday on current and future plans for changes to the 510(k) medical device approval process.
Most of the changes announced today by the Center for Devices and Radiological Health to the 510(k) pre-market notification program for medical devices are favorable to the device industry.
That industry’s made a long practice of advocating for more clarity in the 510(k) process while insisting that there’s nothing fundamentally wrong with the program — by which more than 3,000 medical devices are brought to the U.S. market every year.
Changes to the path by which the vast majority of medical devices hit the U.S. market will help make the U.S. more competitive against European innovators, according to the agency’s top device official.
Dr. Jeffrey Shuren told reporters during a conference call that the changes the Food & Drug Administration plans to make this year to the 510(k) clearance program will help narrow a looming innovation gap between the continents while ensuring the safety of American patients.
"A key piece here is increasing predictability and reducing uncertainty. That is what we’ve heard time and time again," Shuren said.
Medtronic Inc. (NYSE:MDT) CEO William “Bill” Hawkins reacted positively to changes the Food & Drug Administration announced today for its 510(k) program, calling them a “positive sign” that regulators are open to working more collaboratively with industry but denying that the medical device industry won a round in the fight against stricter regulation.
The Food & Drug Administration announced that it plans to make 25 changes to its 510(k) medical device clearance program this year, but will hold off on any major moves until after the release of an Institute of Medicine report scheduled for the summer.
The watchdog agency’s Center for Devices and Radiological Health said it would implement changes including the streamlining of the “de novo” review process for lower-risk devices, more clarity on when medical device manufacturers must submit clinical data in a 510(k) submission and the creation of a council to improve regulatory science.
The Food & Drug Administration’s Center for Devices and Radiological Health will release its proposed changes for the 510(k) regulatory pathway for medical devices, President Barack Obama revealed today.
In an opinion piece for The Wall Street Journal, on how to make U.S.’s regulatory systems more efficient, Obama included one sentence regarding the the process for which 2,654 new medical devices were cleared for market last year.
The Food & Drug Administration’s Center for Devices and Radiological Health saw 29 percent increase in complaints last year, logging a record high of 171 in 2010.
The surge in complaints is less dramatic than the 45 percent increase the agency saw from 2009 to 2010, but the number of contacts, comprised of complaints, disputes and inquiries the agency fielded rose from 250 to 414, up 66 percent.
U.S. marshals seized all the dental devices from a Fla.-based company after a Food & Drug Administration inspection turned up violations in the company’s manufacturing processes.
Acting under court order from the FDA, the marshals on Jan. 5 and 6 removed the products from Hialeah, Fla.-based Rite-Dent Manufacturing Corp., according to the watchdog agency. The seized property is valued at valued at $208,910, the agency said.
Spire Corp.’s (NSDQ:SPIR) medical device unit sued Creganna-Tactx Medical subsidiary Catheter and Disposable Technology Inc. over an alleged breach of contract related to the manufacture of hemodialysis catheters.
The unit, Spire Biomedical Inc., yesterday filed a suit in U.S. District Court in Massachusetts alleging that CDT failed to assemble the catheters in accordance with its designs.
AngioScore Inc. recalled its 0.018″ OTW-design AngioSculpt PTA scoring balloon catheter.
"A small number" of the devices fragmented while in use, and though no injuries have been reported, the Food & Drug Administration branded the recall as Class I.