US FDA Medical Device Regulations

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DECLARATION OF COOPERATION
BETWEEN
THE FOOD AND DRUG ADMINISTRATION OF THE UNITED STATES
THE THERAPEUTIC GOODS ADMINISTRATION OF AUSTRALIA
The AGÊNCIA NACIONAL DE VIGILANCIA Sanitaria OF BRAZIL
AND
GENERAL HEALTH PRODUCTS AND FOOD BRANCH OF CANADA
ABOUT THE PROGRAM SINGLE MEDICAL AUDIT

The Food and Drug Administration (FDA) of the United States. the Therapeutic Goods Administration (TGA) of Australia, the Agência Nacional de Vigilância Sanitária (ANVISA) in Brazil and the General Directorate Health Products and Food Branch (HPFB) of Canada (hereinafter collectively referred to as "participants" ) seek to strengthen existing cooperation in the areas of science and regulations relating to medical devices through the development of the single audit program of medical devices, as described in this Statement of Cooperation.

The goal of the program is to provide a more effective regulatory oversight and less restrictive management systems quality manufacturers of medical instruments. The implementation of this program is to adopt a single audit to meet the regulatory requirements of the participants.

The program objectives are:

  1. Deliver a unique program of verification and the results are reliable;
  2. Provide adequate oversight of quality management of medical device manufacturers while minimizing the regulatory burden on the industry;
  3. Promote a more efficient and flexible use of regulatory resources through the sharing of tasks and mutual agreement of the participants, while respecting the sovereignty of each country;
  4. Promote long-term, greater harmonization of regulatory approaches and technical requirements in the world based on standards and international best practices;
  5. Promote alignment, predictability and transparency of regulatory programs by standardizing practices and procedures for monitoring participants from third parties and verification practices and procedures of the third audit organizations participating in the initiative;
  6. Take full advantage of existing conformity assessment bodies, where appropriate.

Participants in accordance with their respective legal authorities aim to develop a joint work plan adequate for the single audit program for medical devices. The work plan aims to combine the technology, resources and services to improve the security and surveillance of medical devices by making them more efficient and reducing the burden on the industry.

Each participant in this declaration of cooperation plans to finance its participation in this statement. Any participation is subject to the availability of appropriated funds (if applicable), staff and other resources. Each participant is to maintain the confidentiality of shared under this program in accordance with the procedures and policies enjoined by the laws governing the information.

2011-04-18 10:26:37 by NewMsLoree

This is scary... and long...

The Free Speech About Science Act (H.R. 1364), “health freedom,” and misinformed consent
“Health freedom.” It’s a battle cry frequently used by supporters of “alternative” medicine against what they perceive to be persecution by the medical and scientific establishment that uses the Food and Drug Administration, the Federal Trade Commission, and other federal agencies charged with regulating pharmaceuticals, food, cosmetics, and medical devices in order to protect the public against fraud, adulterated food, and quackery. It’s a potent argument to those not versed in skepticism and science-based medicine, and even to many who are

2003-10-21 21:53:47 by dermdoc

Clarification on lasers

I think you are referring to the following statement:
"Several manufacturers received FDA permission to claim, "permanent reduction," NOT "permanent removal" for their lasers. This means that although laser treatments with these devices will permanently reduce the total number of body hairs, they will not result in a permanent removal of all hair. The specific claim granted is "intended to effect stable, long-term, or permanent reduction" through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing after a treatment regime, which may include several sessions

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