• 21 CFR 201.66 Format And Content Requirements For OTC Drug Facts Labeling
• 21 CFR Part 820 - QUALITY SYSTEM REGULATION
• 21 CFR parts 210 and 211 - CURRENT GMP FOR FINISHED PHARMACEUTICALS
• 510(k) submission - Questions about page 2 of form 3654
• 21 CFR Part 11 European Equivalent
• Contract Manufacturer must adhere to 21 CFR 820 - Can FDA require us to do this?
• Requirement to save original, handwritten internal audit notes?
• FDA's view on Wiki's for users to find equipment operation procedures
• Harmonization of ANSI/AAMI PB70:2003, EN 13795?
• Transfer Investigational Device Exemption (IDE) to New Sponsor
• Obama’s health team needs your input
• Device Master Record (DMR) that was compiled by another company
• Only the FDA can sell in USA - Class II medical device
• Is Medical Grade Gas always a drug?
• Timing on 510(k) filing - New medical device
• Legal and clinical conditions for defining Prescription-only devices
• Who does QC (Quality Control) report to?
• 21 CFR 820 - Stability and Validation Requirements
• FDA releases new Draft Guidance - Process Validation - Gen Principles and Practices
• Handguns are now FDA Class I medical devices....
• FDA classifying all PACS software devices as Moderate Level of Concern?
• Design control documentation provided in special 510(k) + FDA response
• How often does the FDA inspect organisations outside of the USA?
• FDA Under Pressure From Congress - Impact on pending 510(k)'s
• 21 CFR Part 820 - in Chinese
• Anyone have experience with ISO/IEC 15189 for medical laboratories?
• Is this legal - Selling all the family products in one 510(k)?
• Process Validation example wanted
• Use of FDA recognized standards: IEC 62304
• Documents / Following Procedures - FDA 21 CFR Part 820 Quality System Regulation
• Millions unknowingly taking unapproved meds
• List of FDA approved Manufacturing facilities (India) ??
• FDA opens new China office in Beijing yesterday
• Latest EU 76/768/EEC Directive
• Major differences between 21 CFR Part 820 and ISO 13485?
• Is there such a thing as FDA Good Documentation Practice (GDP)?
• Latex Free if it comes in contact with a material containing latex?
• Basic questions about Installation, Operational & Performance Qualification - PCBA
• When to issue a CAPA (corrective action preventive action)?
• 21 CFR Part 11 references checklist
• Share 510(k)s with our owner/operator??
• FDA approval (Med Device) - Should we use Accredited Person or proceed on Our Own?
• What would the FDA expect to see when they ask for our QSR?
• Is anyone out there considering using a Third-Party for their FDA Audit?
• Question regarding Device Master Records & Specification Developers
• 21 CFR 820 - Missing Numbers - I have a reference to 820.84
• Existing Device + Existing Device = OK ? New 510(k) required?
• Understanding FDA requirements for Software Validation
• Obtaining Documents from the FDA in Frame of FOIA
• Plastic film materials that will meet both USP and SP?
• PMA (Premarket Approval) - Will inspection of Component Manufacturers occur?
• When the FDA comes a knockin
• Proofreading System (CCD camera reading labels) vs. 21 CFR part11
• Ownership of FDA registered establishment changing - what to do?
• Procedure on Traceability - FDA audit finding
• Is 21 CFR 820 Training Required?
• Confused - Medical Device Reports and Corrections/Removals
• 3rd Party Facility Inspections - In a manufacturer's best interest?
• Only appearance and PCB are changed - Do we need to submit a new 510(k)?
• FDA Class III medical device modification - 510k application
• FDA product Labeling Question - Re-selling and Re-labeling
• Characteristics of predicate device for 510(k)
• PMA (PreMarket Approval) Check List example wanted for Class III Medical Device
• Device Class when used in combination with a device of a higher class?
• Format of Device Master Record (DMR) for Combination Products
• Can a CSA-US certificate substitute a FDA 510(k) clearance?
• Medical Device Reporting - MDRs for incidences outside the US
• FDA Quality Plan - Document Management Responsibility, section 820.20 d
• GHTF, next-gen MDD...headed in the same direction?
• Document Control Software recommendations for Part 11 medical device
• GMP Question for Polyethylene Drum Faucet - Class I Medical Device
• A question arising in my lab in a GLP (Good Laboratory Practice) study
• FDA issued new Guidance for Ultrasound Diagnostic Devices.
• Protocol Agreement - PMA application for Class III Medical devices
• Bulk Class II product sale to kit packers
• Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"
• Sterilization Validation request for 510k
• Bench Test - Definition (in FDA context) and its difference with Clinical Study?
• Date stamp on documents from production - Medical Devices
• Harmonization of device classification with EU MDD?
• ISO/ANSI/AAMI PB70:2003 and EN13795
• Investigator - Lead Study - FDA pitfalls?
• FDA regulations for medical devices distributor in US
• Company Develops Specifications-Manufacturing is Outsourced-Registration Question
• Continuous Spinal Infusion Investigational Device Exemption
• PMAP (single outside audits for both FDA, HC)--anyone doing?
• Relationship between "Corrections/Removals" procedure and "Recall" procedure
• Change in FDA Establishment Registration Fee process wef Oct 1, 2008
• Market application of ISO PB70:2003?
• Industry Standard for Correcting Dates on Documents
• Application for special 510(k) - What are the documents to submit to FDA?
• When to submit a new FDA Device Listing
• Sterility (bacteriostasis/fungistasis) Testing by Membrane Filtration validation
• Biocompatibility of Lexan 244 - Is anyone using Lexan 244?
• Temperature and humidity storage requirements?
• Sterile Field - Legal/formal definition
• FDA - "Net Quantity of Contents" - Manufacturing filling process
• What are the requirements of traceability in FDA's Regulations
• Risk Management for Class I Medical Devices?
• 21 CFR Part 820 Consultant Question
• FDA quantification of AQLs or Quality Levels
• Autoclaving of Class I medical devices
• California FDB (Food & Drug Branch) inspection experiences?
• Medical Device User Fee Rates for 2009
• Device Listing - Format for listing number - What do the different prefixes mean?
• Conflicts between multiple versions of IEC 60601 in regard to structural design...
• When is ISO 10993 biocompatibilty qualification not needed?
• Acceptance Activities-Dimensional Inspection was missed. Parts already assembled
• CDRH Guidance Document - Software bugs submitted in 510(k): Quantity or Quality?
• Control of Design Documents - FDA
• 510(k) FDA Memorandum #k97-1 and S & E decisions
• Traceability of Requirements in the V-Model
• Best practices for GMP training
• Document Approvals and 21 CFR 11 - Electronic signatures and approvals
• FWIW: FDA confused?
• Drug product physical properties stability studies - which properties to test?
• Premarket Approval - What is a Premarket approval? Class 1 Medical Device
• EU Validation Requirement vs. FDA Validation Requirement - EN 62304
• FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
• Oral Complaints - CFR 21 Section 820.198-(2) - Medical Devices
• Rework vs. Reprocess - Definitions - Pharmaceuticals
• What Does "Re-Work" Mean?
• Who is it manufactured by? Manufactured by vs. Manufactured for
• Polymer/Material Specifications - Class 1 Medical Device
• Do we need FDA Approval of the Manufacturing Facility and how do you go about it?
• Laboratory of Assay for Poliolefinas - Section 177.1520 of the FDA and AP89
• Exhibition Equipment - What parts of 21CFR 820 apply to exhibition equipment?
• SOP - Notification to Management of critical or major quality issues
• FDA District Office - How do you know which one to contact?
• Update DHF (Device History Record) when DMR (Device Master Record) changes?
• Email Exposure - Inappropriate statements uncovered in emails
• ISO 13485 certified == cGMP compliance?
• FDA Embarks on Major Hiring Initiative for its Public Health Mission
• USP (United States Pharmacopeia’s) Compliant Packaging Regulations & Process
• List of Countries that require 'Certificates to Foreign Governments' (CFG)
• Calculation for Similarity and Differences in dissolution profile (F1&F2 Values)
• "Performance Specification" vs. "Specification"?
• Reference to FDA on label or labelling
• The Benefits of 21 CFR Part 11
• Performing Investigation of used returned expired devices
• 510k Approval - Does the FDA look for Clinical Data
• Has anyone had to do labeling/comprehension testing?
• Effects of substrate on biological indicator organisms
• Predicate Device - Question on Biocompatibility and IEC 60601-1 Testing Requirements
• Is there an FDA guidance on how to distinguish between Complaint and Repair?
• Defect Awareness Training - Medical Devices
• User Requirement Specification (URS) for off the shelf software.
• The new FDA internet home page - March 2008
• question on FDA and Health Canada
• FDA on path to establish offices in China
• Non-Dairy Creamer - Is there an FDA or other standard for Non-Dairy Creamers?
• Using Faxed Hand Signatures for Approval Records
• Overall Residual Risk Procedure
• 21 CFR Part 11, "enforcement discretion" - Validation, Audit Trail, Record Retention
• Tabular Gap Analysis of the EU (volume 4) and US (210/211) cGMP Regulations
• Can a prescription type material be used as a predicate for an OTC material?
• Changes or Updates in FDA 21 CFR 820 content?
• Audit of Goods In as part of the QSIT "Production & Process Controls" Schedule
• Does an ECG extension cable need a 510k?
• Process Validation - Production Line Transferring to a Different Facility
• FDA Proposes Guidance for Dissemination of Info on Unapproved Uses of Med Products
• APEC Seminar on Harmonization of Medical Device Regulation (4-7, March)
• Specification Developer's 510K submissions
• Production and Process Control SOP example or template needed
• FDA Requirements and/or Standard for Infant Formula Glucose Content
• Good Documentation Practice (GDP) - Actual Results (can they be typed)?
• 510(k) Submission for Outsourced Automated Instrumentation System Components
• Customer Changes to Customer Supplied Documents - Testing Instructions
• GTP (Good Tissue Practice) & GLP (Good Laboratory Practice) Certification
• 21 CFR Part 11 Compliance - Generation of Complete Copies of Records
• DMR (Device Master Record) Revision Requirements? FDA GMP Manual
• Process Validation needed with IDE Approval?
• Risk Management Software suggestions?
• Where to draw the line with Red Lining?
• Do we need to submit our memory foam oxygen mask gasket for FDA approval?
• Requirements to Comply With FDA 21CFR820 For Invitro Diagnostic Device
• Sec. 820.120 Device Labeling & DHR - Count and Document All Labels
• FDA - Audit - Response - Observation form 483. Do we now receive a formal letter?
• Statistical Techniques in Research - Application of 820.250
• Documentation and Record Requirement - What type of pen can be used? 820.180 Records
• FDA Validation - Does one have to conduct validation for Computer Servers?
• Device History Record - Post Shipment - Class II Medical Device w/ embedded software
• Incorporating the Use of a Specific Software in an SOP - Validation of QA Software
• FDA Launches Email Alert Subscription Service
• FDA 21 CFR 820.90 - Nonconformance and Device History, and Rework Records
• Statistical Analysis during Document Audit
• Status of Material Safety Data Sheet (OSHA Compliant) vs. 10993 Certificate
• FDA Compliance - CMC quality and regulatory issues & cGMP - 21CFR parts 210 and 211
• Approximately $2 Million of Potentially Harmful "Cosmetic" Eye Product Seized
• Initial Inspection of Medical Device Manufacturer
• Where can I find old 510(k)s (summaries)
• FDA Audit next week
• Approval - FDA and ISO Definitions
• Part 11 Requirements - Medical Devices vs. Pharmaceuticals
• Organizing Medical Device Requirements - How you carried out yours?
• Applicable Guidelines for Use of Regrind Materials
• Liability for Packaged Drug products Sold Indirectly in the International Market.
• Could we get FDA approval just for subsystem - FDA approved medical device
• Requirements for Registering and Listing with the FDA
• GIVE (Generic Initiative for Value and Efficiency) Launched by the FDA (US)

vB Easy Archive Final ©2000 - 2009 - Created by Stefan "Xenon" Kaeser