The final rule from the FDA establishes a new category of over-the-counter hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers.
The Experiential Learning Program (ELP) provides CDRH review staff with an opportunity to visit sites and gain a better understanding of the products they review. The 2023 ELP Site Visit Proposal period is open now until September 6, 2022.
Before product developers can more confidently design RWE studies and venture away from the traditional path of lengthy prospective studies, industry must overcome several challenges. This article provides insight on these barriers and perspective on how industry might fully realize the promise of RWE in the near-term to advance health care.
Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and clinical data may allow a clearer understanding of regulatory expectations to emerge.
The FDA does not intend to enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices, regardless of whether they are consumer health products, before December 8, 2022.
The committee will be discussing skin lesion analyzer technology and its application in detecting skin cancers in various patient care settings as well as the potential reclassification of approved computer-aided melanoma detection class III devices.
Guidance includes information about what’s protected—and what is not—when using period trackers and other health information apps on smartphones.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to concerns raised by medical device trade associations regarding future regulation of medical devices in the United Kingdom.
Evidence Partners and Akra Team Join Forces To Help Medical Device Companies Accelerate Completion of EU MDR and IVDR Submissions
The partnership brings together Evidence Partners’ literature review platform, DistillerSR, and Akra Team’s strategic regulatory services.
FDA Issues Final Guidance on Technical Performance Assessments of Quantitative Imaging in Premarket Submissions
Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.
