Medical device manufacturers need to carefully manage several important outward streams of information regarding their products. The regulatory community is generally most familiar with the data stream that relates to obtaining clearance to market devices, which involves communications directly with the FDA. The FDA data stream is customarily well integrated with a firm’s internal regulatory functions of review and approval. However, there are other data streams that are critical to the commercial success of device manufacturers.
CAPA is often overlooked as an integral component of a quality system. More often than not, the FDA can trace deficiencies in a system directly back to the CAPA system. However, an effective quality system needs more than just a rework of the outcome of the ineffective CAPA system. It needs a rework of the system itself.
You've already read a few benefits in the title but let's reiterate:
- Earn RAC points
- Enhance your resume/LinkedIn profile
- Get published, and share your expertise with industry peers in the process
These are just three of the several reasons you should consider writing an article for RAPS' Regulatory Focus.
Don't sweat it if writing isn't your forte - there's nothing to be afraid of. The editorial board is there to you help you bring your ideas to life (and correct all those grammatical and punctuation errors). And once you get started, the entire writing process usually takes less time than you think. RAPS is looking for authors for the September and October 2016 issues of Regulatory Focus. Or... maybe you have an idea for an article that could appear in any issue? Either way, now is your chance and here are more specific details.
This week I will provide some information about labeling in India. CDSCO (Central Drugs Standard Control Organization) regulates the medical device industry in India. Only medical devices that CDSCO has put in the “Notified Devices Category” require registration. There are very few product types on this list and they are regulated as “drugs”. Registration is not required for import of non-notified medical devices in India. Please refer to the link below for a list of the notified device categories that must be registered in India:
As you might expect, here at RQS the responsibilities and duties of providing our clients with the support they need often involves traveling for on-site visits. For the time being, most of the travel takes place within the greater metropolitan area of the cities in which we currently have offices: Cleveland and Pittsburgh. Our Pittsburgh team makes rounds to their Pittsburgh-based clients and our Cleveland team makes rounds to their Cleveland-based clients. However, in order to best meet our clients’ needs, there is a fair bit of interchanging resources between our offices. Employees, some more than others, travel within the two metropolitan areas providing support to clients in both regions, as needed. Having been one of our Pittsburgh-based employees who has frequently traveled to Cleveland for client support, I thought I would use this blog post to reminisce on the journey.
How much time to you spend searching FDA’s website? Looking for predicates, collecting adverse event reports from the MAUDE database, searching for guidance documents, etc. I’m sure I don’t need to dig into the details, you have felt this pain too if you have spent any appreciable amount of time on the www.fda.gov. Albeit a great source of information, it is a complex web of blue pages, and it takes a very large amount of time (and money!) to find the information you are looking for.
RQS team members pride ourselves on focusing on customer success, and it is with that in mind that I am honored to announce our most recent 510(K) submission was approved this week! We are proud to obtain clearance, but swell with pride because of how we obtained it.
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.
Recently I had to get my annual mammogram. They were running behind like doctor’s offices sometimes do - there were seven women in dressing gowns in the waiting room with me. After a few awkward moments, we all started to talk to each other. Every single one of the ladies talked about how they hate to come and get their annual mammograms. They talked about the pain of it, joked about the embarrassment of it - there was even a suggestion that they should serve wine in the waiting room instead of coffee. But each also showed a deep appreciation for the necessity of breast cancer screening - telling stories of aunts and mothers who were saved by it. Finally one woman told us that she was 39 when a mammogram detected her breast cancer for the first time. She was able to get minor surgery and was put on a regimen of annual mammograms. Six years after, she got breast cancer again. Again the mammogram was able to catch it early. She said she was now 57 years old and she felt like she owed 18 years of life to her doctor who suggested she get a mammogram at 39. There is no doubt about it; mammograms save people’s lives.
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.