Content tagged with FDA

19 results

FDA releases top 3 medical device regulation goals

FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paper that FDA’s CDRH released today.


FDA plans reorganized “super office” for device regulation

The FDA is planning a new “super office” for its Center for Devices and Radiological Health department and the soon-to-be created Office of Product Evolution and Quality, according to a Regulatory Affairs Professionals Society report.


FDA lays out plans to improve post-market medical device oversight

The FDA today laid out plans for improving post-market medical device oversight, including a significant investment in its new National Evaluation System for health Technology.


FDA: Updated predicate devices will improve safety, efficacy in 510(k) clearances

The FDA yesterday released a notice explaining why it believes a push for modernizing predicate devices used in equivalence testing within the 510(k) clearance pathway will improve overall safety and effectiveness.


New FDA guidance explains electronic record requirements for medical device clinical trials

US Food and Drug Administration medical device regulators have published new draft guidance recommending proper use of electronic records and signatures in clinical investigations. The new guidance applies to clinical trial sponsors and investigators as well as Institutional Review Boards (IRB) and clinical research organizations (CRO) that must comply with 21 CFR Part 11 regulations pertaining to electronic records and signatures.


FDA Issues Guidance on Informed Consent Waivers for Minimal Risk Studies

The US Food and Drug Administration (FDA) on Monday issued a final guidance detailing the circumstances in which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants.


FDA Finalizes Guidance on Drug/Device Combination Product Classifications

The FDA finalized guidance on its process for assigning applications to a specific regulatory center, hoping to answer frequently asked questions from industry sponsors regarding whether their product will be classified as a drug or as a device.


FDA Medical Device Guidance Documents to be Issued in 2018

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has prioritized guidances for topics including Unique Device Identification, 510(k) premarket notification issues and voluntary consensus standards for its 2018 fiscal year.


FDA finalizes streamlined bundled, quarterly MDR reporting system

The FDA today announced it finalized its new Voluntary Malfunction Summary Reporting Program intended to streamline medical device manufacturer malfunction reporting.


FDA hopes new disruptive wearables will lead to ‘universal digital future in healthcare’

The FDA is hopeful that devices like the new Apple (NSDQ:AAPL) Watch, which is designed to provide on-the-spot electrocardiogram tests and detect atrial fibrillation, will lead to a “reimagination of healthcare delivery”.