FDA - Final MDDS Rule - Federal Register Full-Text

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Updated August 7, 2023:

The original link broke.

You might also be interested in:
MDDS Rule - a webpage on FDA.gov

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The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions without controlling or altering the function or parameters of any connected medical devices. An MDDS is not intended to be used in connection with active patient monitoring. FDA is exempting MDDSs from the premarket notification requirements. This rule is effective April 18, 2011.

Read the full-text of the MDDS rule in the Federal Register [Volume 76, Number 31 (Tuesday, February 15, 2011)].

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Pharma Jargon Buster

Here's a nifty reference to add to your bookmarked favorites relating to pharma, biopharm, medical device, dietary supplements, and more.

NSF-DBA's Jargon Buster, lists abbreviations and acronyms, with their associated meanings.

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Electronic Orange Book Online

Updated Aug 18, 2016:

FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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The FDA offers an electronic (online) version of the Orange Book, also known as Approved Drug Products with Therapeutic Equivalence Evaluations.

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Drugs.Com - Popular and Free Pill Identifier

The internet is really something. Where else can you find free resources like this popular Drugs.com Pill Identifier?

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ASQ Announces Certification Exam For GMP Professionals

Updated May 24, 2016 - Old links just don't age well. I've made some edits.

PharmTech reports, New GMP Professional Exam Offered. It's great to see the bar getting raised with the proliferation of GMP certifications. It's nice to see the American Society for Quality (ASQ) jump into the fray by offering a certification exam based on their understanding of the body of knowledge (BOK) deemed necessary for GMP pros.

There are various degrees of rigor in GMP certifications being offered out there. Where do you think this will fit into the certification scene?

For more information:
ASQ Training & Certification
ASQ - The Value of an ASQ Certification

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Cross-Reference GLPs by FDA EPA and OECD (free)

If you ever had an interest or need to compare the GLPs (Good Laboratory Practices) across these three organizations, then you need to look at the FDA's "Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP." The information is organized in tables that cross-walk and cross-reference a particular row topic against the three columns for each organization. 

Here's what you'll be able to see:

Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP - FDA.gov

Table of Contents

• Preface
• Scope and Authority
• Definitions
• Organization and Personnel
• Facilities
• Equipment
• Facility Operation
• Articles
• Protocol and Conduct
• Records and Reports
• Disqualification

Glossary: GLP = Good Laboratory Practice FDA = Food and Drug Administration EPA = Environmental Protection Agency OECD = Organisation for Economic Co-operation and Development 

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