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The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2019. The Federal Food, Drug and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2019, which apply from October 1, 2018, through September 30, 2019.
Section 738 of the FD&C Act (21 U.S.C. 379j) establishes fees for certain medical device applications, submissions, supplements, notices, and requests, for periodic reporting on class III devices; and for the registration of certain establishments. Under statutorily defined conditions, a qualified applicant may receive a fee waiver or may pay a lower small business fee.
The FDA medical device user fees will increase by about four percent for the agency’s 2019 fiscal year.The latest FDA user fee increases are much less substantial than those put in place last year. The FY 2019 revenue from adjusted fee is projected to be $207,708,611.
The medical device user fee rates for the fiscal year 2018 were significantly increased by 33% or more (under the Medical Device User Fee Amendments of 2017 (MDUFA IV)). The standard fee for 510(k) premarket notification submissions increased around 125% (from $4,690 to $10,566). The FDA created the De Novo applications fee for the first-time last year.
Read more about this update in our whitepaper.
<p style="margin: 0in 0in 10pt;"><span>When the first Generic Drug User Fee Act (GDUFA I) was enacted in 2012, The FDA’s Office of Generic drugs (OGD) was trying to manage a growing backlog of regulatory applications. The introduction of user fees to the generic drug approval process permitted FDA to increase resources to address the increasing review and inspection demands. In addition, GDUFA I set forth performance goals for the FDA over a 5-year span, resulting in reductions in both the generic drug application backlog and application review times. </span></p>
“Retro.” “Vintage.” “Nostalgic.” These can be great terms to describe that classic car you have your eye on, but they are not great when describing your primary drug product packaging. Many of today’s drug products are still packaged with elastomer formulations and designs that were first developed over 50 years ago.<span> </span>Generic companies that simply replicate the innovator packaging could be affecting their operation negatively for many more years to come.<span></span><p> </p>
The combination product market has seen a significant amount of growth,<sup>i</sup> driven primarily by the rise in chronic disease indications, the demands for self-administered therapies and technological advancements. The use of combination products simplifies the process of drug administration for the patient and/or the caregiver and, in some cases, allows the patient to receive treatment at home rather than having to travel to a medical facility. However, there are many challenges that need to be navigated as one considers the transition from a vial system to a needle-based combination product.
On September 7th, 2023, a long-awaited final guidance was issued by the Food and Drug Administration (FDA) - Application of Human Factors Engineering Principles for Combination Products: Questions and Answers. The document is intended to be used in conjunction with other human factors related guidance and available national and international standards, such as AAMI HE75 and IEC 62366. In this latest guidance, the agency provides its view on best practices for conducting human factors activities for combination products either comprised of a device and a drug or a device and biologic.
One of the increasing trends in the world of drug-device combination products is the use of platforms for drug families, delivery device technologies, and primary packaging.
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