[PSES] FDA requirements for medical products containing wifi modules

Dear experts, I was yesterday speaking with one client who is quite desperate. They are producing medical products which contain wifi modules. They have told me, that FDA currently does not accept any such product if no additional testing on wifi module inside the unit are performed. The proble

RE: FDA requirements for beauty treatment device

Hello Peter, This may be similar to the product in question: http://www.alliedhealth.net/micro_ablation.htm Best regards, Ron Wellman At 10:12 AM 4/9/2003 -0700, Peter L. Tarver wrote: >Nick - > >this sounds like one of those electric skin/muscle toner >devices. > >While I didn't find specifi

Re: FDA requirements for beauty treatment device

Hello Nick, I'd be curious as to what claims the manufacturer makes for this beauty treatment product. That may determine one thing in regards to potential misbranding under FDA regulations but if there are similar devices already on the market in the USA, I would check to see how they are cla

RE: FDA requirements for beauty treatment device

Nick - this sounds like one of those electric skin/muscle toner devices. While I didn't find specific reference to this type of device, it appears to be treated as a medical device and not a cosmetic. Refer to http://www.cfsan.fda.gov/~dms/cos-derm.html for another type of product that was mi

FDA requirements for beauty treatment device

I've been asked to take a look at the requirements for a beauty treatment product which the client wants to push for the US market. It works by passing a small current through the skin. The client is adamant that this is not a medical device in the sense of the EU Medical Devices requirements

RE: FDA requirements

, Constance Brown constance.br...@conformityassessment.com Tel: 978-524-9890 Fax: 978-524-9898 -Original Message- From: owner-emc-p...@ieee.org [mailto:owner-emc-p...@ieee.org] On Behalf Of Nick Williams Sent: Tuesday, July 04, 2000 11:15 AM To: emc-p...@majordomo.ieee.org Su

RE: FDA requirements

Hello Nick.. Try here as a starting point: http://www.fda.gov/ Good Luck , George -Original Message- From: Nick Williams [mailto:nick.willi...@conformance.co.uk] Sent: Tuesday, July 04, 2000 11:15 AM To: emc-p...@majordomo.ieee.org Subject: FDA requirements Can somebody give me a

Fwd:FW: FDA requirements

forwarding for Constance. From: Constance R. Brown [mailto:constance.br...@conformityassessment.com.cnchost.com] Sent: Wednesday, July 05, 2000 8:40 AM To: Nick Williams; emc-p...@majordomo.ieee.org Subject:RE: FDA requirements Nick, The best site for all this information is

RE: FDA requirements

AM To: emc-p...@majordomo.ieee.org Subject: FDA requirements Can somebody give me a good pointer for resource in relation to the US FDA requirements (i.e. what is covered, and what the requirements are?) I've been asked to consider what might be required for the sale of a clinical thermo

FDA requirements

Can somebody give me a good pointer for resource in relation to the US FDA requirements (i.e. what is covered, and what the requirements are?) I've been asked to consider what might be required for the sale of a clinical thermometer for consumer use in the US. Regards

RE: X-Ray testing to FDA requirements

etc.ie Sent: Wednesday, August 18, 1999 5:13 PM To: Non-HP-emc-pstc /HP-PaloAlto,shargw3/dd.HPMEXT1=emc-p...@majordomo.ieee.org Cc: Non-HP-feej /HP-PaloAlto,shargw3/dd.HPMEXT1=f...@netc.ie Subject: X-Ray testing to FDA requirements Hi all, I have been asked by a client if there are any E

X-Ray testing to FDA requirements

Hi all, I have been asked by a client if there are any European test houses that can perform X-ray testing on monitors to FDA requirements. I do not have any more specific details. Anyone able to help? Thanks John Fee NETC f...@netc.ie

FDA requirements

Thanks for all your replies (espeicaly Lou, i did ask to see where it was written but still haven't seen it yet!). Everybody seems to have agreed with what i said to our engineer, so hopefully he'll now go away and let me get on with my job. Thanks MJ

RE: FDA requirements

/www.x-rite.com> -Original Message- From: Martin Johnson [SMTP:calpe1...@yahoo.com] Sent: Friday, June 25, 1999 6:42 AM To: emc-p...@ieee.org Subject: FDA requirements When producing equipment that uses flat screen (LCD) 1/4 VGA displays, is there any requirement to

RE: FDA requirements

As far as I am aware, the FDA requirements (21CFR) relate to the emission of X-rays from CRTs within monitors. We always state that any LCD displays within our products are therefore exempt from the FDA requirements. I also have on file a letter to "all manufacturers and importers of telev

RE: FDA requirements

this requirement. -- From: Martin Johnson [SMTP:calpe1...@yahoo.com] Sent: Friday, June 25, 1999 6:42 AM To: emc-p...@ieee.org Subject: FDA requirements When producing equipment that uses flat screen (LCD) 1/4 VGA displays, is ther

FDA requirements

When producing equipment that uses flat screen (LCD) 1/4 VGA displays, is there any requirement to meet FDA emission requirements (overall equipment is not for medical use, and would never find its way into a hospital environment). I only ask as one of my collegues is quite insistent that we have

FDA Requirements for Computer BIOS???

Does anyone know what specific FDA regulations would cover a system used in medical imaging? It appears that it can go down to the BIOS level. Happy Holidays Glenn Lesmeister glenn.lesmeis...@compaq.com Compaq Tel: 281-514-5163 20555 SH 249

RE: FDA Requirements

afety Engineer Eaton Corporation ph:512 248-2851 fax: 512 248-2050 email: jbu...@aus.etn.com > -Original Message- > From: Mike Morrow [SMTP:mmor...@compuserve.com] > Sent: Thursday, August 27, 1998 8:04 AM > To: IEEE EMC Board &g

Re: FDA Requirements

equire/specify finishes to contact materials that are in the 15 to 35RA range depending on application. Regards, Jim From: Mike Morrow Subject: FDA Requirements Date: Thu, 27 Aug 1998 09:03:58 -0400 To: IEEE EMC Board I've always been told that any piece

RE: FDA Requirements

Devices -- From: Mike Morrow To: IEEE EMC Board Subject: FDA Requirements List-Post: emc-pstc@listserv.ieee.org Date: Thursday, August 27, 1998 6:03AM I've always been told that any piece of equipment being used in a "sanitary" application (i.e. food processing, etc) must be

FDA Requirements

I've always been told that any piece of equipment being used in a "sanitary" application (i.e. food processing, etc) must be constructed of stainless steel. I'm after the actual standard that has this requirement. Can aluminum be used?? Any help is appreciated. Mike Morrow

RE: FDA requirements

-301-855-1375 Fax:001-410-586-1460 Email: band...@resemc.com Web;www.resemc.com -- From: becky...@aol.com [SMTP:becky...@aol.com] Sent: Thursday, August 13, 1998 4:32 PM To: emc-p...@majordomo.ieee.org Subject: FDA requirements I am working on a machine that has electrodes

Fwd: FDA requirements

In a message dated 98-08-13 16:32:29 EDT, Becky001 writes: << emc-p...@majordomo.ieee.org >> --- Begin Message --- I am working on a machine that has electrodes that are attached to the skin to measure various electrical signals. This machine is battery powered. My question is : am I required