R&Q's Blog

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

 

Review Controls Applied to Outgoing Data Streams (Because the FDA Might Be)

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.

Free Webinar: CAPA on CAPA, Presented by MassMEDIC and R&Q - Register Now!

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. 

Industry Advice: Earn RAC Points and Enhance Your Resume by Writing for RAPS' Regulatory Focus

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 FocusOr... 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.

India Medical Device Labeling

 

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:

http://cdsco.nic.in/Medical_div/list%20of%20notified%20medical%20device.0001.pdf

If your device does not fall into one of the types on this list, it doesn’t require product registration.

For Medical Devices that do fall under Notified Devices Category (per CDSCO), products are required to have labeling as per the labeling requirements under GHTF guidelines and Rule 96 of the Drugs and Cosmetic Act, (which can be found at the following link):

http://cdsco.nic.in/Drugs&CosmeticAct.pdf

In India, medical devices are categorized as “drugs”. Some of the labeling requirements in Rule 96 are specific to drugs, and will not pertain to medical devices. According to rule 96, the following items must be on the labeling for Notified Devices:

1. product description

2. number of units of contents,

3. The name of the manufacturer and the address of the premises of the manufacturer where the product has been manufactured.

4. A distinctive batch number, being preceded by the words ‘Batch No.’ or ‘B. No.’ or ‘Batch’ or ‘Lot No.’ or ‘Lot’.

5. Every product manufactured in India shall bear on its label the number of the license under which it is manufactured, the figure representing the manufacturing license number being preceded by the words “Manufcaturing Licence Number” or “Mfg. Lic. No.” or “M.L.”.

6. Date of manufacture, and the date of expiration

In addition, these products also need to comply with labeling and local laws as per Drug Price Control order and Standard Weights and Measures Act 1976 & Rules 1977.

As per Standard Weights and Measures Act 1976 & Rules 1977, the manufacturer shall indicate the following information on the package:

1. Name and Address of Manufacturer/Importer/Packer
2. Quantity
3. Generic Name of Product
4. Maximum Retail Price (M.R.P.) inclusive of all taxes:
5. Date of manufacture/ (Imported or Packed) Expiration Date
6. Contact information (Name, Address, Telephone Number and E-mail address) for Customer Complaint

Most of which is redundant.

Some frequently asked questions can be found on the CDSCO website at:

http://cdsco.nic.in/FAQ-IMPORT%20&%20REGISTRATION%2002022013_DONEE.pdf

Good luck with your labeling!

Same Road (Regulatory Pathway), Different Car (Medical Device)..Similar Success (Clearance,Approval)

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.

Regulatory Intelligence

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.

510(K) Success!

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.

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.

Human Factors

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.

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.

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