Skip to main content

Reauthorized Medical Device User Fees for FY 2008 - 2012

The legislation on the Medical Device User Fee Amendments of 2007 (MDUFA), is part of a larger bill — the Food and Drug Administration Amendments Act of 2007 (H.R. 3850) and according to this, a substantial reduction for all existing application fees have been proposed, while providing for new types of medical device user fees.
The new user fees are proposed for:
• Submission of a 30-day notice.
• Submission of a 513(g) request for classification information.
• An annual fee for periodic reporting on a class III device.
• An annual fee for the registration of a medical device establishment that is a manufacturer, a single-use device reprocessor, or a specification developer.
On the other hand all existing application fees are substantially reduced for PMA, Panel-track PMA Supplement, BLA Efficacy Supplement, as well as 510(k) Notification remarkably for small businesses in a range between -18 – 70%.

Follow this link to read more on this:
Medical Device User Fees Have Been Reauthorized for Fiscal Years 2008 - 2012

BayBiotech.NET

Comments

Post a Comment

Popular posts from this blog

Amendments for High Risk Device Type Regulatory Pathway

BayBiotech.NET Government Accounting Office (“GAO”) has issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”) in the January of 2009. Report mainly focused on Preamendment class III devices. Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA. Under the Safe Medical Devices Act of 1990, FDA was required either to reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency. GAO has urged FDA to take required steps to address the remaining class III devices that continue to be eligible for 510(k) review. As a result of the report, FDA has committed to address al...
Post a Comment
Read more

Harmonization by Doing (HBD): Japan & U.S. Collaboration

BayBiotech.NET HBD is an international cooperative effort by Japan and US for regulatory convergence for Medical Devices. The efforts are focused on to develop global clinical trials and address regulatory barriers for timely device approvals. To address the needs for additional evaluation, the HBD initiative is a pilot project launched jointly by FDA and MHLW-PMDA for the premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD is focused on Proof of concept by utilizing parallel development, application submissions and review of actual medical device projects. HBD Study intends to collect and analyze regulatory submission data from multiple applications in the U.S. and Japan. The purpose of the study is to further understand differences that may exist with format and content, to define best practices and to improve globally harmonized processes. To read more about the HBD program, follow the link: http://www.fda.gov/M...
Post a Comment
Read more

510(k) Summary or Statement

BayBiotech.NET A premarket notification from a manufacturer must include either a summary of the 510(k) safety and effectiveness information of the product upon which the substantial-equivalence determination is based or a statement that this information will be made available by the 510(k) applicant to any person within 30 days of a written request. As per FDA definition, these are the definition of Summary and Statements: Summaries are released by FDA regarding a 510(k) clearance when requested under the Freedom of Information (FOI) Act whereas Statements are used to arrange for this FOI request to be fulfilled by the 510(k) applicant. 510(k) Summaries: If a summary is included, it must be submitted with the 510(k) notification as per FDA guidelines. The summary must be complete and correct in order for FDA to complete its review of a 510(k) submission. FDA will accept summaries and amendments until it issues a determination of substantial equivalence. If a summary has be...
Post a Comment
Read more