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

FDA MDUFMA Small Business Determination (SBD) at the Pre-Revenue Stage

July 27, 2021 FDA MDUFMA Small Business Determination (SBD) at the Pre-Revenue Stage   Before addressing FDA’s MDUFMA fees and SBD program for a firm’s premarket submission when at a pre-revenue / premarket stage, my suggestion is to first remember that if a product clearance or approval [510(k) clearance, PMA approval, etc.] hasn’t happened yet, […]

FDA Remote Regulatory Assessment

July 16, 2021 FDA Remote Regulatory Assessment   For the U.S. medical device jurisdiction, a client and I a couple weeks ago went through an FDA Remote Regulatory Assessment (RRA).  Here’s a recap:   FDA contacted the firm and informed them that, due to the current SARS-CoV-2 (COVID-19) situation, the FDA is conducting inspections [called […]

Showing Conformity to Standards

July 16, 2021 Showing Conformity to Standards   Regardless of the source of a request for evidence showing conformity with applicable standards, a pivotal underlying fundamental remains the same and drives the answer:  Conformance with standards is generally a design/development verification and/or validation activity.  Therefore, the general rule of thumb is that there needs to […]

FDA DRAFT guidance for animal studies of medical devices…

October 2015   The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “General Considerations for Animal Studies for Medical Devices.”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 […]

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

August 2015   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 […]

FDA DRAFT guidance distinguishing device recalls from enhancements…

February 2013 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements.” This draft guidance intends to clarify for industry when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and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 […]

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

January 2013 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 […]

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

January 2013 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

November 2012 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, […]