R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Pre-Submission Program – Final Guidance

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 novo, etc.). The sponsor may submit a pre-submission application to the FDA requesting answers to various questions about the marketing application or clinical trial design of their device. The sponsor may request a written response, teleconference, or meeting. The FDA has committed respond to the sponsor within 75 to 90 days.

FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device

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 what I would change to make it more straight forward. While I can appreciate how difficult it is to make general rules that can apply to an infinite variety of products, there are sections of this document that could certainly be clarified.

New Biocompatibility Draft Guidance

FDA issued a new draft guidance document on biocompatibility on Tuesday April 23, entitled Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation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 was issued in 1995 in the span of 18 years a lot has changed regarding FDA’s view on biocompatibility.

Autonomy with Boundaries

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 good kid, full of promise…..and he knows the boundaries. No phone while driving, no friends in the car, follow the law and safety first.

Open Comments are Not Left Unheard!

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.

Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

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.

New "Refuse to Accept" Guidance Document for 510(k)s

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 the changes to the policy and the issues they have with them. As always, the draft guidance document went through the review process where companies could read through the document and provide comments. Several leading medical device companies provided feedback and comments and can be found in this article.

October brings awareness to women’s health issues

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 survivors in the U.S. has improved from 63% in the early 1960’s to 90% today. Thanks to advances in technology and awareness of the disease, we have been able to make great strides.

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