Latex Free Labeling Revisited
On April 23, 2013
the FDA issued draft guidance on the Use of ISO 10993, "BiologicalEvaluation of Medical Devices Part 1: Evaluation and Testing".
This guidance document would
finally supersede Blue Book Memorandum #G95-1 for medical devices.
I won't go into much now, but it does include a section on Labeling
Devices as "-Free" (such as Latex Free, DEHP Free, etc.) which I've cut and pasted
below:
So there you have
it. It seems reasonable and easier to label with "Not made with natural rubber latex" than to go with the old
"Latex Free" which had ambiguous requirements. While this
guidance is still in its draft form, this section seems fairly
non-controversial and I'm sure you could go ahead and start following it now without issue.
If you do not like
the proposed rule, you are still free to comment on it by following the
instructions on the guidance document.
40 comments:
It's funny how much time regulators spend on semantics. It would be ideal if they could devote more time to streamlining and overhauling requirements so that they are not only less burdensome but also more effective and relevant. I'm actually not an anti-regulation proponent. On the contrary, I believe strongly in regulation, when it's non-redundant, narrow and specific in focus, and in step with the exigencies of modern healthcare. I think that regulation should be completely overhauled every 5-10 years, with bonuses allocated to the admins who can streamline it and shorten the overall compliance.
*I have a potential feature for your site that I would like to submit. Is there a contact person/email address whom I can connect with? Thank you.
I agree with the anonymous previous comment: regulators spend definitely too much time on studying semantics.
I do believe that, on the otehr hand, a complete overhaul every 5-10 years wouldn't be appropriate: I would say that a 3-5 revision of the regulation would be fair.
yes medical devices is more important and also the software because these will help the physicians and the staffs working in medical field. They are in need of medical devices that will be more helpful to them in medical field. And i want to share this www.complianceonline.com in this site i got some more information about medical device and FDA
Hello,
Just a note to let you know that I added your blog to my blog roll at Medicaldevicesuccess.com. Any comments you have about my site would be appreciated.
Best regards
Ted
Hello,
My name is Subodh Das and I am the CEO and Co-Founder for a start up medical device company based in Lexington, KY. The name of the company is Fluid Management Systems and we have developed a patented system for wireless measurement of fluid levels sealed inside vials. This is a breakthrough technology that will shape inventory management in the animal and health markets. I follow your blog and also have a blog of my own. I encourage you to check out my blog at: http://fluidmanagementsystem.com/blog/. I would appreciate any opportunity to guest blog for Medical Device Blog and look forward to hearing back from you!
E-mail: subodh@fluidmanagementsystem.com
information, kudos to you! It is good and correct. The usefulness and importance is overwhelming. Thanks again for this unbelievably powerful post and good luck!
GE 10S
Nice, interesting post... thanks for posting!
Thanks for Sharing information. It is really good. Because we always purchase devices for our convince. But we never know about these devices. They are working correct or not. For this medical device test is needed.
This is a wonderful article, Given so much info in it, These type of articles keeps the users interest in the website, and keep on sharing more ... good luck.
Liquid Level Switch
This is great information. I learned a lot here
ماستر للتوريدات الطبيه
معنا في ماستر للتوريدات الطبيه سوف تجد جميع الاجهزة الطبيه النسائيه و الرجاليه و بأفضل الاسعار التي لا تقبل المنافسه و سوف تجد اجود الانواع الاصليه الغير مقلده و للتواصل معنا اتصل بالارقام
توريدات طبيه
00201155094446
00201155072226
00201021712626
او راسلنا عبر البريد الالكترونى
http://www.mastermasr.info
Best Equipments Manufacturers & Suppliers for Medical Hsspital
Hospital Furniture
Hospital table
Hospital bed
I think you should explore the articles on your website, You should also cover different different categories for articles as you writes awesome. Thanks for sharing this great article with us.
medical instruments
تواصل الان مع مركز صيانة فيليبس وتعامل مع اكفا المهندسين واكثرهم خبرة من خلال توكيل صيانة كاريير للاجهزة الكهربائية فقط عند تواصلك مع خدمة العملاء الان تمتع باقوى الخصومات على الصيانة وقطع الغيار
Great service, I liked your best services about medical device Very informative and well written post! Quite interesting and nice topic chosen for the post Nice Post keep it up.Excellent post.
Medical Collections
www.missionbaydentalcare.com
San Diego Dentist
Dentist in San Diego
An excellent information provided thanks for all the information i must say great efforts made by you. thanks a lot for all the information you provided.
Packers And Movers Mumbai
An excellent fact provided thanks for all of the information i should say awesome efforts made by you. thank you a lot for all of the data you supplied
Regulatory Writing Services for Medical Devices
Excellent information provided by you,
Thank you so much............
medical devices recall services
medical device alerts
Awesome article, it was exceptionally helpful!
Miami Florida web design company
Miami Florida web design
Thanks for sharing such a nice blog..
Business Phone Equipment Austin
Business Continuity and Recovery Austin
Thanks for sharing such a Beautiful article with amazing stuffs about Medical equipment manufacturers
Knowledge blog post, and thanks. Medical Equipment
https://cgiflythrough.com/
It is no secret that I have a very deep and personal relationship with God. I have pushed and resisted that relationship this past year through all the bullshit I have had to go through living with Herpes but once again, God is bigger than my stubbornness and broke through that outbreak cold sore and all I had Genital Herpes. For me personally, hearing over and over how I am not good enough has really invaded my mind in the worst way possible. I completely shut down and I was just waking up like is this how life going to end this temporary herpes outbreak “fuck everybody with herpes if you know what I mean” but let's be honest here...
It is a cowardly to say no to herbal medicine. It is fear based. And it is dishonest to what my heart wants. Don't build a wall around yourself because you are afraid of herbals made or taking a bold step especially when it's come to health issues and getting cure. So many young men/ women tell me over and over that Dr Itua is going to scam me but I give him a try to today I feel like no one will ever convince me about herbal medicine I accept Dr Itua herbal medicine because it's cure my herpes just two weeks of drinking it and i have been living for a year and months now I experience outbreak no more, You can contact him if you need his herbal medicine for any such diseases like, Herpes, Schizophrenia,Cancer,Scoliosis,Fibromyalgia,Fluoroquinolone Toxicity Syndrome Fibrodysplasia Ossificans Progressiva.Fatal Familial Insomnia Factor V Leiden Mutation ,Epilepsy Dupuytren's disease,Desmoplastic,Diabetes ,Coeliac disease,Creutzfeldt–Jakob,,Lyme Disease,Epilepsy, ,ALS,Hepatitis,Copd,Parkinson disease.Genetic disease,Fibrodysplasia disease,Fibrodysplasia Ossificans Men/Woman infertility, bowel disease ,Huntington's disease ,Diabetes,Fibroid. disease,Lupus,Lipoid Storage diseases( Gauchers disease),Polycystic Disease.,Cerebral Amyloid Angiopathy, Ataxia,Cirrhosis of Liver,Arthritis,Amyotrophic Lateral Sclerosis,Alzheimer's disease,Adrenocortical carcinoma.Asthma,Allergic,HIV, Epilepsy, Infertility, Love Spell,. Email..drituaherbalcenter@gmail.com then what's app.+2348149277967.... My advice to any sick men/women out there is simple... Be Always an open book. Be gut wrenching honest about yourself, your situation, and what you are all about. Don't hold anything back. Holding back will get you nowhere...maybe a one way ticket to lonelyville and that is NOT somewhere you want to be. So my final truth...and I'm just starting to grasp this one..
Book Independent Mumbai Escorts Service 5 star Hotels, Call us at 9100000000, to book Hot and Sexy Call Girls Mumbai with Photos in all suburbs of Mumbai.
Best Escort services in Mumbai | Escorts services in Mumbai | Independent Call Girls in Mumbai | Russian Escorts in Mumbai | Collage Call Girls in Mumbai | Celebrity Escorts in Mumbai | Call Girls Mumbai Whatsapp No | Mumbai Escorts Whatsapp Phone Number | Mumbai Escorts Phone Number | High Class Mumbai Escorts | http://www.mahichopra.com, Mumbai Escorts
Hi there! great post. Thanks for sharing some very interesting and informative content it is a big help to me as well, keep it up!!!
ISO 13485 Certification
Here is Mr Benjamin contact Email details, 247officedept@gmail.com. / Or Whatsapp +1 989-394-3740 that helped me with loan of 90,000.00 Euros to startup my business and I'm very grateful,It was really hard on me here trying to make a way as a single mother things hasn't be easy with me but with the help of Mr Benjamin put smile on my face as i watch my business growing stronger and expanding as well.I know you may be surprised why I put things like this here but I really have to express my gratitude so anyone seeking financial help or going through hardship with their business or want to start a business project can see this and have hope of getting out of the hardship..Thank You.
THERE IS A CURE FOR HIV/AIDS Never give up in life they all said there is no cure for HIV, which is a big lie I have passed through many processes. Also, I never believed there is really a cure to HIV/AIDS until I met Dr. James. The doctor that has been helping people for many years, I came across this doctor online when I was searching for an HIV permanent cure online. I found out about Dr. James, and to my greatest surprise Dr. James has the herbal medicine for HIV cure which I have been looking for years I explained my problems to him through the email I found on someone who testified about Dr. James herbal mix write me a reply and explain how the process work so after ordering for the medicine I got it within 4 days and I took it according to the way Dr. James instructed me, I was very happy after 21 days I took the medicine there was very big change in my health when I was done with the process I went for a test, I found out I am negative that was the day I have the tears of joy after all i have been through. You can also get in contact with my doctor through his email now (Greatcureman@gmail.com) And He also has herbs medicine to cure the following diseases; Nephrotic Syndrome, eczema, urethra wart, chronic problems. Herpes, Cancer, ALS, Autism, Hepatitis, Diabetes, HPV infections, Hives, shingles, blistering, ulcer, Painful or Irregular Menstruation. HIV/Aids. Diabetics. Vaginal Infections. Vaginal Discharge. Itching Of the Private Part. Breast Infection. Discharge from breast. Breast Pain & Itching. Lower Abdominal Pain. No Periods or Periods Suddenly Stop. Women Sexual Problems. High Blood Pressure Chronic Disease. Pain during Sex inside the Pelvis. Pain during Urination. Pelvic Inflammatory Disease, (PID). Dripping Of Sperm from the Vagina As Well As for Low sperm count. Parkinson's disease. Lupus. Cancer. Tuberculosis. Zero sperm count. Asthma. Quick Ejaculation. Gallstone, Premature Ejaculation. Herpes. Joint Pain. Stroke. Weak Erection. Erysipelas, Typhoid, Discharge from Penis. HPV. Hepatitis A and B. STD. Staphylococcus + Gonorrhea + Syphilis. Heart Disease. Pile-Hemorrhoid.rheumatism, thyroid, Waist & Back Pain. Male Infertility and Female Infertility. Etc. Take Action Now. Contact him & Order for your Natural Herbal Medicine: and email him Greatcureman@gmail.com...INFO@Drjamesherbalmix@gmail.com.
Packers and Movers Bangalore as a Services providing company can make all the difference to your ###Home Relocation experience. Bangalore based Company which offers versatile solutions, Right team that easily reduce the stress associated with a ✔✔✔Household Shifting, ***Vehicle Transportation. we help things run smoothly and reduce breakages and offer you seamless, Affordable, Reliable Shifting Services, Compare Shifting Charges. @ Packers And Movers Bangalore
Thanks for sharing this blog with us
Healthcare products equipment in Thane
Healthcare Professionals Competency Testing (HPCT) is a certifying agency that offers national certifications to allied healthcare professionals including Surgical Technicians, Clinical Medical Assistants, Medical Administrative Assistants, EKG technicians, Patient Care Technicians, Pharmacy Technicians, Phlebotomy Technicians, and Sterile Processors. With HPCT, Surgical technologists are able to sit for their national certifying examination before the completion of their scrubs. Surgical Technicians perform various tasks before, during and after surgery. They ensure an infection-free environment during surgery. They also make sure the surgeon's needs during surgery are met to ensure a safe environment for the patient. Visit surgical tech national test
I was searching for a proper explanation about medical devices. Thanks, admin, for sharing such wonderful content on this topic. Now I have got everything I need about it. Here’s another informative content on Global RQC, You will get well-researched information about it.
Amazing piece of content, Thank you for sharing this ideas.
Biocompatibility For Medical Devices
biocompatibility testing ISO 10993
nice medical devices supplier
Nice Comment...
LAB FURNITURE EQUIPMENTS SUPPLIERS IN CHENNAI
Lab Equipments Supplier in Chennai
Science Lab Equipments Supplier in Chennai
Water Testing Instruments Supplier in Chennai
Lab Tables Manufacturers in Chennai
thanks for more information Medical Devices Company
Thanks a lot for making this post available to us.
Biocompatibility For Medical Devices
biocompatibility testing FDA 510K
At the Law Office of DRASIN, YEE, AND SANTIAGO., we work hard to distinguish ourselves by the way we treat our clients and the quality of our legal services. Our Workers’ Comp Lawyer aim is to protect the rights of injured workers in San Diego, California.
Workers' Compensation
construction accident.
Post a Comment