<h1 class="entry-title">Category: FDA</h1>

FDA DRAFT guidance for animal studies of medical devices…

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “General Considerations for Animal Studies for Medical Devices.” FDA has developed this guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies for medical devices. The intent of this draft guidance […]

FDA updates guidance for its 510(k) Refuse to Accept Policy…

FDA released updated guidance addressing its screening acceptance process for 510(k) notifications. FDA has also made corresponding changes to the associated ‘Acceptance Checklist for 510(k)s’. The revised guidance provides updates explaining the current procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be […]

FDA DRAFT guidance distinguishing device recalls from enhancements…

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements.” This draft guidance intends to clarify for industry when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and identify the reporting requirements […]

FDA announces availability of e-submission process for requesting CDRH export certificates…

On January 22, FDA announced via Federal Register the availability of an electronic submission process for requesting export certificates for products regulated by FDA’s Center for Devices and Radiological Health (CDRH). The e-process is aimed to help meet certain requirements set out by the FDA Export Reform and Enhancement Act of 1996 and other FDA […]

Has FDA recently rejected your medical device submission e-copy?

If you’ve had your FDA medical device submission e-copy rejected recently by FDA, you’re probably not alone. When firms submit the mandatory e-copy of their medical device submissions, FDA now requires the e-copy to conform to a mind-boggling array of specifications. Here are links to FDA’s corresponding Federal Register announcement and guidance document.

FDA publishes a revised UDI proposed rule

On November 19, 2012, FDA published a revised UDI proposed rule to accommodate the enactment of FDASIA, which was signed into law (Pub. L. 112–144) on July 9, 2012. Specifically, pursuant to FDASIA, the purpose of the revised UDI proposed rule is to specify the date by which a proposed rule is required, to identify […]

Wondering how FDA’s UDI rule might affect labelers? Here’s a non-exhaustive summary

• This is a “proposed rule” (no actual regulations have been amended/promulgated yet). The proposed rule is due for publishing via FR next week. • Stakeholders will have 120 days to lodge comments/concerns with FDA before FDA initiates the “final rule” stage. • All devices [201(h) of the Act] will require UDI except: – Those […]

FDA to implement or reach a major milestone this year (2011) for forty-two of its prior fifty-five 510(k)-process recommendations

In August 2010, FDA released for public comment a two-volume set of documents entitled “[CDRH] Preliminary Internal Evaluations,” which is comprised of the preliminary reports of two internal committees: The 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making.  Volume I is entitled “510(k) Working Group Preliminary Report […]