R&Q's Blog

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

 

R&Q's Christine Santagate Featured in Medical Design & Outsourcing

Image via Medical Design & Outsourcing

Staying at the forefront of the medical device industry takes work - a lot of it, in fact. Communication with R&Q's peers in the industry is in large part how our employees do it, and a big part of that is addressing hot topics in the industry. R&Q's own Client Solutions Advisor Christine Santagate was featured in MassDevice's May 2016 issue of Medical Design and Outsourcing in an article titled, "Everything You Ever Wanted to Know about Starting a Medical Device Company." The publication serves as a fantastic how-to guide for startup companies. Here's what she had to say.

The Med Device Industry (and the FDA) Embrace 3D Printing Innovation

Just this week the world's first 3D-printed office opened in Dubai. It took all of 17 days to print a 2,700-square-foot building at half the price of conventional methods. In short, this 3D printing thing has some legs... and we mean that literally, too.

3D printing is definitely a hot topic across the medical device industry. This ground-breaking technology that began in the 80s has advanced into a valuable tool for manufacturers, and even earned itself draft guidance from the FDA earlier this month.

Pediatric Subpopulations – Final Rule

On Friday, January 10, 2014 the FDA issued a final rule, which amends the premarket approval (PMA) regulations. The final rule requires “submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat”. 1 The final rule also defines “pediatric patients” and “pediatric subpopulations”. Per the final rule, “pediatric patients” is defined as a patient who is 21 years old or younger at the time of treatment or diagnosis. “Pediatric subpopulation” means on for the following populations: neonate, infants, children, or adolescents.

FDA gives Voice to the People

The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has launched a new initiative targeted at giving the patients a voice in the agency’s decision making process on medical devices. I became aware of this effort by the FDA when recently reading this article which describes CDRH’s program called Patient Preference Initiative.

License Amendment Triggers in Canada

Sometimes changes in process can have a dramatic effect on product registration. There are several events that can cause a re-registration of a registered medical device. A new product name, part number, material, manufacturing site, country of origin, business name or manufacturing process are common re-registration triggers. It all depends on the specific regulations of the country involved.

I recently had to deal with a company that had changed contract manufacturers; the legal manufacturer and owner of design control remained the same. This move also involved a change in the country of origin. We were concerned specifically how this affected the current license in Canada. I read the Health Canada Guidance for Interpretation of Significant Change of Medical Device and the License Amendment Fax-Back Form from the Health Canada website. After reading these documents, I felt that an amendment to the license was necessary. I wasn't entirely sure. I asked a few colleagues for their opinion. After reading carefully, none of us were fully clear what path we needed to take in order to meet the requirements.

However, the one great thing about Health Canada is that the Medical Device Bureau is as polite and helpful as the rest of the country. We were quickly able to get clarification via email from the Device Licensing Services Division. Basically here is what we found out: If the products in question are Class II devices, then a License Amendment Fax-Back Application is not required (you can inform Health Canada when the product is renewed). However, if the devices in question are Class III or IV, then a License Amendment Fax-Back Application is needed.

Luckily, our devices were Class II, so we did not need to fill out the License Amendment Fax-Back Form. Thanks for your help, Canada!

 

 

Health Canada Guidance for Interpretation of Significant Change of Medical Device please see the following website:

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/md-im/applic-demande/guide-ld/signchng_modimportante-eng.pdf

License Amendment Fax-Back Form please see the following website:

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/form/fb_licnamechng_fm_modnomhom-eng.php

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!

Device Idea to Staying Power in the Market

Have a medical device idea and want to make sure no one steals it? Have a product and are stuck somewhere between clinical trials and clearance? Let's say you have clearance and customers, but you aren't sure you're going to get paid? The start-to-finish product group of experts at this Pittsburgh Technology Council breakfast briefing can help you out! The experts will provide a brief overview of their specialty area and be available following the session for confidential discussions. So, bring your questions and be ready to discuss your product!

Event Details:

Tuesday, August 27, 2013 | 7:30 am - 11:30 am
Venue: K&L Gates, 210 Sixth Ave., Pittsburgh, PA 15222
Cost: $45 Members | $175 Non-Members
RSVP: Online | events@pghtech.org

Agenda:

7:30 am Registration & Continental Breakfast
8:15 am Program
11:30 am Conclusion

Experts:
Protect your Idea - K&L Gates
Set the Strategy - Maria Fagan, Regulatory and Quality Solutions
Create the Design - Carolynn Johnson, Daedalus
Demonstrate Clinical Utility - Chris Hoyer, CardiacAssist
Obtain Clearance - Speaker TBD
Get Paid - Sharon Kim, Zoll Medical Corporation
Build It - Pat Sims, TMG Electronics
Go to Market and Stay There - Larry Kopyta, Omnyx

The Life Sciences Network (LSN) is sponsored by K&L Gates.
Event Sponsor: Regulatory and Quality Solutions

For more information on the event, or the Pittsburgh Technology Council, contact Jennifer G. Young (jyoung@pghtech.org), Managing Director, Advance Manufacturing & Life Sciences Networks.

-RTK

Image courtesy of the Pittsburgh Technology Council

Mobile Medical Applications: Make Sure uChek with FDA

The latest mobile medical application news on the industry's collective mind is the issuance of an "It has come to our attention..." letter sent to Biosense Technologies in India, essentially questioning why Biosense has not obtained 510(k) clearance for their uChek mobile application. The device is a mobile medical application for phones that takes a picture of urinalysis strips and compares the color against a standard to make a determination about the status of a patients urine. It also includes a box that controls external light to ensure better quality of the results. From a "fan" standpoint, it's an awesome device and technology. You can see it demo-ed during the TED talk given by the company's CEO.

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.

Complaint Handling Solutions

In my last post “Who’s watching your MedWatching”, I commented on some of the common issues manufacturers have with their MDR and complaint handling systems. It’s useful to know what people are doing wrong, but I think it is equally important to know how to solve those issues. So in this post, I’m going to point you to two very good resources that I found that give further insight into how to know if you have a problem, and how to fix your system.

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