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Presentation and Networking: Is A Medical Device Hiding In Your Product Portfolio? Join R&Q at MassBio!


Organizer

Us! Regulatory and Quality Solutions (R&Q)

What?

A presentation and networking event over lunch addressing how an accessory or tool, in reality, is often a medical device.
 
This session will discuss combination products and the use of accessories with drugs and biologics. We will review examples of product types that may not be obvious and also what to watch out for during the development process. Finally we'll look at some MDR examples where the device types were not initially disclosed or identified correctly.

Would you like fries with your Combo meal?

On January 18, 2013, the FDA announced their final rule on current good manufacturing practices for Combination products. These Guidance Documents will tell companies when submissions would be required for any post-approval changes to a combination product.
First off, what are Combination products you may ask? It is any combination of a drug, a device, or a biological product. As defined in 21 CFR 3.2, this may refer to two or more regulated components that are physically or chemically combined into a “single” entity, or even a “kit” combination where the before-mentioned are packaged together in a single package.
The Combination Products Coalition (CPC) sees this as an excellent move by the FDA, and hopes it will reduce the amount of duplicated work for drug, device, and biological product requirements.
But with the new Combination policies, how will this affect current manufacturers? A big long term “pro” might lead to a short term “con” as companies will need to modify their current Quality Systems to accommodate this new rule. Also, what will this do to the number of combination product filings? Will companies take this as a positive, or see it as an additional hurdle?
-SJG

Final Rule - Combination Products

Last week, the FDA issued a final rule(1-2) on combination products(3) and the applicable current good manufacturing practice (CGMP) requirements. The final rule actualizes the proposed rule that was issued many moons ago, in September 2009 without significant changes. Four sections comprise the final rule(1-2); §4.1 - Scope, §4.2 - Definitions, §4.3 - Applicable CGMPs, and §4.4 - Single-entity or co-packaged combination products compliance with these requirements.

Exploding Bombs?

I have to admit, school doesn't teach you everything. During my first week at RQS, I was working with a client, and we were discussing labeling. She said I needed to get the bomb. Then, if I explode the bomb, everything will be good, and I'll have what I need. I left her office a little bit confused, and then it dawned on me that she did not want me to cause any sort of mass destruction...just to look at the BOM (Bill of Materials). Phew! It's just part of the jargon of the industry. Everyone uses abbreviations, numbers, code names, and pneumonic devices to mean any number of very important things.

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