Medical Device Regulations 820

MD - ISO 13485

Medical Devices - Pilot Project of the Food and Drug Administration of MD with ISO 13485:2003 certification.

ha emesso, in data 19 marzo 2012, un importante documento Guidance for Industry, Third Parties and Food and Drug Administration Staff "Medical Device ISO 13485:2003 - Voluntary Audit Report - Submission Pilot Program" , rendendo cosi definitiva la bozza in circolazione dal maggio del 2010, riguardante la possibilità, per determinate condizioni descritte nel documento stesso, di ridurre gli audit di sorveglianza periodica sui dispositivi medici per i produttori con Sistema di Gestione Qualità certificato ISO 13485:2003. The Food and Drug Administration issued on 19 March 2012, an important document Guidance for Industry, Third Parties and Food and Drug Administration Staff "Medical Device ISO 13485:2003 - Voluntary Audit Report - Submission Pilot Program, " thus making the final draft in circulation since May 2010, concerning the possibility for certain conditions described in the document itself, to reduce the periodic surveillance audits on medical devices for producers with a Quality Management System certified to ISO 13485:2003.

It 's interesting to note that, among the various possibilities, it was also considered the notification process, linked to CE marking under the European Medical Devices.

Attached is the full version and the original document.

FDA - Dispositivi medici

The table, below, the translation of some salient passages of the document.

"A national producer (USA) or a foreign medical device that is subject to the obligations set out in 21 CFR Part 820, Quality System Regulation, are entitled to participate in the voluntary program ISO the following circumstances:

1. The audit report is submitted to the FDA within 90 days from the last day of the most recent audit of ISO 13485:2003;

2. The audit is performed using the ISO 13485:2003 "Medical devices - Quality management systems - Requirements for Regulated"

3. The audit was performed by a qualified auditor within one of the founding members of the GHTF regulatory system (means qualified in accordance with the specific guides GHTF - which also regulate the planning and conduct of audits - and ISO 19011)


a. The system of conformity assessment of the Canadian Medical Devices (CMDCAS);

b. The Notified Body under the European system of medical devices;

c. The Therapeutics Goods Administration of Australia, Office manufacturing quality;

Createspace an Company Devine Guidance For Complying With The FDA's Quality System Regulation - 21 CFR, Part 820
eBooks (Createspace an Company)
2006-02-20 17:02:02 by Bioseeker

8 years in biotech

I've been working consistently in the biotech field, after a BA in Psychobiology for 8 years.
-Regulatory Affairs deals with getting FDA approval of new drugs and medical devices.
I went to the Biospace job fair last month but haven't got any calls. I'm wondering if its b/c I currently reside in LA. I'm thinking of moving down there and looking for something fast thru a temp agency. Any advice?

2009-01-11 15:13:59 by windshadow

More from hsi

Last month, a group of FDA scientists sent an SOS to Representative John D. Dingell, chairman of the House Committee on Energy and Commerce. The letter calls for "urgent intervention" due to "serious misconduct" by managers of the Center for Devices and Radiological Health (CDRH) – the FDA division that oversees everything from imaging equipment to breast implants.
So what constitutes "serious misconduct"?
Here's how the scientists put it: "There is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices

2007-09-08 13:08:25 by -------

Chip implants shown to cause cancer, a

"When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients' medical records almost instantly. The FDA found "reasonable assurance" the device was safe, and a sub-agency even called it one of 2005's top "innovative technologies."
But neither the company nor the regulators publicly mentioned this: A series of veterinary and toxicology studies, dating to the mid-1990s, stated that chip implants had "induced" malignant tumors in some lab mice and rats

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