"Critics say the F.D.A.’s process for reviewing medical technology, under which medical devices have become a $75 billion-a-year industry in this country, is often too lax," reports this New York Times news article, "Quickly Vetted, Treatment Is Offered to Patients." In general, the 510(k) process is intended to be a quick-review process that promotes innovation, and that most new devices improve upon an existing device so there is rarely is a need for full review.
Read the article for yourself. Some controversial issues are raised that you might be interested learning about. You be the judge.
Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/
Thursday, October 30, 2008
Medical Devices - A murky 510(k) world?!
Subscribe to:
Post Comments (Atom)
Custom Search
From SkillsPlus International Inc.
Top Content And Other Useful Links
- GMP Posters - for Training & Quality
- FDA 483 Inspectional Observations - learn from these examples
- WHO Basic GMP Training Modules (free)
- FDA Orange Book - Online (free)
- GXP Acronym Gifts (gift, award, reward & recognition, giveaway)
- The Health, Drug, Prescription, and GMP Supersite Gift Store (gifts, awards, rewards & recognition, giveaways, mugs, bags, mousepads, coasters, posters, and more!)
Custom Search
Even More Resources, Books, & Things (many from Amazon.com)
FDA, GMPs, QSR, GCP, GLP, GXP:
21 CFR Parts 210 and 211: Drug Industry GMP's
Compact Regs Parts 807, 812, and 814: CFR 21 Parts 807, 812, and 814 Medical Device Approval (10 Pack)
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
Compact Regs Part 11: CFR 21 Part 11 Electronic Records; Electronic Signatures (10 Pack)
How to Fail an Fda Quality Audit: A Look at Some of the Causes of Failure to Comply With Fda Quality Regulations
Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance
How to Develop and Manage Qualification Protocols for FDA Compliance
Agent GXP FDA Part 11 Guidebook: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... Trials and GCP (Good Clinical Practices)
Development of Fda-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics)
Clinical Studies Management: A Practical Guide to Success
Analytical Chemistry in a GMP Environment: A Practical Guide
Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Biotechnology and Bioprocessing Series)
Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook
Preclinical Drug Development (Drugs and the Pharmaceutical Sciences)
Group Sequential Methods: Applications to Clinical Trials (Chapman & Hall/Crc Interdisciplinary Statistics Series)
Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition
Pharmaceutical Stress Testing: Predicting Drug Degradation (Drugs and the Pharmaceutical Sciences)
Cleaning Validation: A Practical Approach
Validated Cleaning Technologies for Pharmaceutical Manufacturing
Risk-Based Compliance Handbook
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume I (1)
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded (Volume 2)
Bioprocess Validation: The Present and Future
Laboratory Validation: A Practitioner's Guide
Quality Assurance Workbook for Pharmaceutical Manufacturers
Risk-based Software Validation: Ten Easy Steps
ISO 13485 and FDA QSR Internal Audit Checklist
ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms
Training Resources:
1001 Ways to Reward Employees
Planning Programs for Adult Learners: A Practical Guide for Educators, Trainers, and Staff Developers, 2nd Edition
50 Creative Training Openers and Energizers
Personalized M&M Candies
Oriental Trading Co - Training toys and supplies
GMP Training Gifts & Giveaways
GMP Training & Quality Posters
21 CFR Parts 210 and 211: Drug Industry GMP's
Compact Regs Parts 807, 812, and 814: CFR 21 Parts 807, 812, and 814 Medical Device Approval (10 Pack)
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
Compact Regs Part 11: CFR 21 Part 11 Electronic Records; Electronic Signatures (10 Pack)
How to Fail an Fda Quality Audit: A Look at Some of the Causes of Failure to Comply With Fda Quality Regulations
Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance
How to Develop and Manage Qualification Protocols for FDA Compliance
Agent GXP FDA Part 11 Guidebook: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... Trials and GCP (Good Clinical Practices)
Development of Fda-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics)
Clinical Studies Management: A Practical Guide to Success
Analytical Chemistry in a GMP Environment: A Practical Guide
Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Biotechnology and Bioprocessing Series)
Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook
Preclinical Drug Development (Drugs and the Pharmaceutical Sciences)
Group Sequential Methods: Applications to Clinical Trials (Chapman & Hall/Crc Interdisciplinary Statistics Series)
Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition
Pharmaceutical Stress Testing: Predicting Drug Degradation (Drugs and the Pharmaceutical Sciences)
Cleaning Validation: A Practical Approach
Validated Cleaning Technologies for Pharmaceutical Manufacturing
Risk-Based Compliance Handbook
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume I (1)
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded (Volume 2)
Bioprocess Validation: The Present and Future
Laboratory Validation: A Practitioner's Guide
Quality Assurance Workbook for Pharmaceutical Manufacturers
Risk-based Software Validation: Ten Easy Steps
ISO 13485 and FDA QSR Internal Audit Checklist
ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms
Training Resources:
1001 Ways to Reward Employees
Planning Programs for Adult Learners: A Practical Guide for Educators, Trainers, and Staff Developers, 2nd Edition
50 Creative Training Openers and Energizers
Personalized M&M Candies
Oriental Trading Co - Training toys and supplies
GMP Training Gifts & Giveaways
GMP Training & Quality Posters
Posts
0 comments:
Post a Comment