Articles By Sara Jerome
-
Senators Push For Regenerative Medicine Study
11/18/2013
A bipartisan group of senators wants the U.S. Government Accountability Office (GAO) to assess federal involvement in regenerative medicine. In a letter to the GAO, the senators framed it as a step toward ensuring that federal funding in this arena is being used efficiently, especially in light of the budget crisis.
-
FDA Recognizes 12 IEEE Technology Standards For Medtech Communication
11/18/2013
IEEE, a professional association for the technology industry, commended the FDA this week for recognizing 12 IEEE 11073 health informatics standards that enable communication between medical, healthcare, and wellness devices and with external computer systems.
-
FDA Unveils List Of Soon-To-Be Published CDRH Guidance Docs
11/14/2013
The FDA rolled out a list of guidance documents that the CDRH plans to publish in the next fiscal year, according to a recent entry in the Federal Register. The list is broken down into "A-list" documents, which the agency "fully intends to publish," and "B-list" documents, which it will publish as resources permit.
-
Da Vinci Robotic Surgery System Gets Mixed Reviews In New FDA Report
11/13/2013
The FDA released the results of an investigation into Intuitive Surgical’s da Vinci Surgical System in the wake of increased publicity resulting from product recalls, media coverage, and litigation. The agency conducted a survey with surgeons from hospitals of various sizes who each performed 70 to 600 surgeries using the da Vinci surgical robot over the last three years.
-
Government Sitting On $85 Million In Sequestered FDA User Fees
11/11/2013
Federal sequestration has pulled about $85 million in user fees from the FDA, and more cuts may be coming, according to the White House's Office of Management & Budget (OMB).
-
Supreme Court Hears Patent Fight Between Medtronic, Boston Scientific
11/8/2013
Two medical technology giants appeared before the Supreme Court this week in a case that could have far-reaching consequences for how device makers defend their patents.
-
India's Medical Device Bill Raises Concerns For Manufacturers
11/7/2013
Medical device companies are lobbying Indian officials against creating harsher punishments for breaches by tech manufacturers than those imposed by international standards. The Advanced Medical Technology Association (AdvaMed) told the Parliament of India in a recent filing that all the regulations for medical devices should align with widespread best practices, such as those set by the International Organisation for Standardization (ISO) and International Medical Device Regulators Forum (IMDRF).
-
Regulators Flesh Out Details On International Medical Device Audit Program
11/5/2013
Regulators in Australia, Brazil, Canada, and the U.S. are taking the next step toward streamlining the quality system inspection process for medical devices across international borders, under the Medical Device Single Audit Program (MDSAP). An MDSAP pilot program exploring that possibility will launch in January, the FDA said in a document released last week.
-
CDRH Playing Catch-Up On Device Reviews After Shutdown
11/1/2013
The FDA has fallen behind on its medical device review process as a result of the 16-day partial shutdown of the federal government last month. The agency was unable to process 100 sumbissions it received during the lapse, and it's bracing itself for a wave of submissions in the coming weeks from companies that withheld submissions or were awaiting small business designations during the furlough.
-
FDA Report Examines Personalized Medicine Regulations, Challenges, And Opportunities
11/1/2013
Maximizing growth in the field of personalized medicine will require new technology solutions for mining the vast quantities of data that have become available in recent years. That is one of the observations in a new FDA report seeking to identify challenges within this emerging medical domain. The report, released this week, sought to clarify the agency's current and future role in personalized medicine.