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, […]
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 […]
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 […]
October 2015 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “General Considerations for Animal Studies for Medical Devices.”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 […]
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 […]
February 2013 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements.” This draft guidance intends to clarify for industry when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and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 […]
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 […]
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.
December 2012 Link to FDA press release.
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, […]