The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices.
Center for Devices and Radiological Health (CDRH)
Physician burnout: Meet patient safety
The majority of doctors in America today care deeply about their patients. After all, they’re the ones that have personal relationships with them. They’re the ones who sit with them, speak with them eye to eye, feel their pain, and witness first-hand the scourge of disease on the human body and psyche.
FDA releases January 510(k) clearances
January 2013 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD January 2013
FDA details changes to medical device review groups
The FDA this week provided updates on the revamped Office of In Vitro Diagnostics & Radiological Health, formerly known as the Office of In Vitro Diagnostic Device Evaluation and Safety.
The Center for Devices & Radiological Health subsection will oversee in-home and laboratory diagnostic tests, radiological medical devices and radiation-emitting non-medical products, and will be responsible for implementing the Mammography Quality Program established federally in 1992.
FDA launches new device guidance website
The FDA launched a new medical device guidance website, aiming to streamline the way the agency publishes and solicits comments on guidance documents developed by the Center for Devices & Radiological Health.
The new site includes a docket for comments where stakeholders can offer suggestions, propose draft language and comment on the priority of topics for guidance during 2013.
FDA unveils reorganized device review unit | MassDevice.com On Call
MASSDEVICE ON CALL — The FDA’s medical device review arm unveiled a new organization scheme, adding a pair of new review divisions and 12 new branches.
The Center for Devices & Radiological Health began operating under the new plan at the start of the month, featuring separate divisions for surgical and for neurological/physical medicine devices.
The agency hopes to "reduce the manager to staff ratios and better align product areas as well as accommodate the new MDUFA hires that will be coming into the Center," according to the FDA Law Blog.
FDA releases April 2012 PMA approvals
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 120
Summary of PMA Originals Under Review
Total Under Review: 66
Total Active: 29
Total On Hold: 37
Number Greater Than 180 Days: 1
FDA’s Shuren: “The canary in the coal mine is actually singing these days”
The FDA has made important strides in improving its medical device review process, devices chief Dr. Jeffrey Shuren said this week.
Since beginning an audit of the agency’s med-tech review procedures nearly 2 years ago, fewer medical device market applications have been sent back to companies and average decision times are on the decline, Shuren told an audience at the Memphis Bioworks Assn. Monday.
Internal FDA disputes may affect regulatory outcomes for medical devices
Internal disputes at the FDA’s Center for Devices & Radiological Health need better management in order to avoid disruptions to the medical device review process, according to the U.S. Dept. Of Health & Human Services’ Office of the Inspector General.
Although most of the disputes involved disagreements over fulfilling agency requirements, some may have come from lack of clarity and uncertainty about the submission process, according to the OIG.
GOP Sens. Burr and Coburn team up for PATIENTS’ FDA Act
Sens. Richard Burr (R-N.C.) and Tom Coburn (R-Okla.) introduced a new bill today aimed at reducing the medical device industry’s regulatory burden.
The duo’s "Patients’ Act" (Promoting Accountability, Transparency, Innovation, Efficiency and Timeliness at FDA) would "ensure that the FDA is held accountable for its performance goals and is fulfilling its public health mission on behalf of patients in a predictable and timely manner, including decisions on life-saving drugs and devices," according to a press release.
FDA: Safety, efficacy, public health – and economy?
FDA officials and consumer advocates balked yesterday at legislative attempts to alter the federal watchdog agency’s mission statement to include promoting job growth, competition and economic growth.
A U.S. House version of a bill reauthorizing FDA user fees for medical devices and pharmaceuticals would include economic obligations FDA officials said would distract from the agency’s responsibility to patients.