RQM+ Medical Device and In Vitro Diagnostic Blog

on 21 February 2014 | By Ryan Kasun

On February 18, the FDA issued the final guidance document for the Pre-Submission Program and Meetings with FDA Staff. The Pre-Submission process is a way for industry to get feedback from the FDA prior to the submission of a premarket application (PMA, 510(k), HDE, IDE, de...

on 29 May 2013 | By Ryan Kasun

The FDA is looking for industry input for the revision of FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device,” January 10, 1997. This is a critical go-to document for the average Regulatory Engineer, so I have been thinking about...

on 25 April 2013 | By Ryan Kasun

FDA issued a new draft guidance document on biocompatibility on Tuesday April 23, entitled Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. It is intended to replace the ODE General Program Memorandum #G95-1. G95-1...

on 4 March 2013 | By Ryan Kasun

I have a teenager that just passed his Driver’s Test. As he pulls out of our driveway, I see the freedom, the possibilities, the trouble that he could get into. Although a bit poetic and a bit melancholy, it’s also a bit exciting. His father and I cautiously trust him – he’s a...

on 26 February 2013 | By Ryan Kasun

Some may think the FDA does not take what industry has to say to heart or feel that there is no point in commenting on a proposed rule, because their feedback is left unread.

on 28 January 2013 | By Ryan Kasun

In addition to the Refuse to Accept Policy for 510(k)s Guidance document I discussed in my previous post, the FDA also issued a guidance titled Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) at the same time.

on 14 January 2013 | By Ryan Kasun

There has been much controversy about the new RTA FDA Guidance document titled "Refuse to Accept Policy for 510(k)s". The draft of this guidance was issued for review in August of 2012 and was recently released at the end of that year. However companies are still talking about...

on 25 October 2012 | By Ryan Kasun

October is a very important month for women: It’s National Breast Cancer Awareness Month. There are many things to be proud of for how far we have come with treating breast cancer. The Susan G. Komen Foundation reports that the 5-year survival rate for female breast cancer...