The Elsmar Cove Discussion Forums > National and International Business Standards > FDA (United States Food and Drug Administration)

1. Could we get FDA approval just for subsystem - FDA approved medical device
2. Nickel Allergies - How low of a percentage of nickel can be in stainless steel?
3. ISO 13485 - Part 11: Electronic Records - Small Biotech Company - What is required?
4. FDA vs. Materials requiring Refrigeration - Dental adhesives
5. FDA - Change of US Agent - Don't want to use the US agent for our own products
6. Retroactive application of harmonized standards
7. New Japanese EMC/electrical safety standards - Additional product testing required?
8. Are there any guidelines for writing an Intended Use statement?
9. FDA Quality Plan - Document Management Responsibility, section 820.20 d
10. Statistical Techniques in Research - Application of 820.250
11. FDA - Design Control Forms - Medical devices (Class I and II
12. FDA - Audit - Response - Observation form 483. Do we now receive a formal letter?
13. Anyone have experience with ISO/IEC 15189 for medical laboratories?
14. Documents / Following Procedures - FDA 21 CFR Part 820 Quality System Regulation
15. FDA 510(k) required? US company private labeling a FDA class II device
16. Tracebility requirements in Pharma vs Medical Devices - Nonconformance issue
17. FDA is nobody's "lapdog"
18. Labeling and advertising - Advertising claims made by Distributors - Medical devices
19. Labeling of Medical Devices - Distributor replacing device serial number label
20. Does anyone have any information on FDA's SMG 2020 issued Oct 04.
21. Is anyone out there considering using a Third-Party for their FDA Audit?
22. FYI - FDANews Calls for authors
23. Is a registrar obligated to inform the FDA of NCRs that could be considered 483s?
24. How does the FDA's SMG 2020 compare to ISO/TR 10013:2001?
25. Medical device class 1 Complaint investigations
26. FDA District Office - How do you know which one to contact?
27. Can pharmaceutical companies delegate some responsibilities to supplier?
28. Sec. 820.120 Device Labeling & DHR - Count and Document All Labels
29. Concession Procedure FDA Guidelines - medical devices.
30. Federal Warning on Packaging - Both the inner and outer packaging? Class I Medical
31. New FDA Forms - 2891 Registration of Device Establishment, FDA 2892 Device Listing
32. Control without blueprints - Sewing department - Medical Devices
33. FDA 21 CFR 820.90 - Nonconformance and Device History, and Rework Records
34. FDA - Reference to checking for "patent infringement" during Design Control process?
35. Part 11 - Changes to a system validated to Part 11 - What to revalidate?
36. 21CFR820-820.50 Purchasing controls - Using Non-Approved Suppliers
37. Top FDA guy resigns - impact on industry?
38. FDA Annual Registration - Any harm to be FDA (form FDA 2891a) registrated
39. FDA requires 7 Years of Support? UL 544 for Extended Support? End of Life of Product
40. SOP's & Part 11 - Including Sec 11.50 Signature Manifestations
41. CFR Title 21 820.72.b accuracy and precision
42. New format for 510(k)'s - Guidance document from the FDA
43. What results of a design review are documented in a DHF?
44. FDA Compliant Electronic Records - Requirements, definitions, maintenance and archive
45. Instructions for Use (IFU) - On the manufacturer's website vs. On the product label
46. Use of Declaration of Conformity in Traditional 510(k)???
47. Where to find FDA requirements for new products
48. For non-US manufacturors: Statement of distributor on insert/labelling
49. Temperature indication In Vitro Medical Devices USA
50. How costly can a quality system problem be? Guidant vs. the FDA
51. Good Manufacturing Practices - How you document your GMP's - GHP's and how detailed
52. 21 CFR Part 11 - Securing Electronic signatures using Adobe Acrobat
53. Implementation of the FDA requirements into the existing Quality Management System
54. QSR Training - I am looking for a new QSR training program
55. Has anyone evr had to submit a DMF (Drug Master File) with the FDA?
56. FDA approval required for a supplier to a medical device manufacturer?
57. SUPAC (Scale Up and Post Approval Changes) guidelines for pharmaceuticals
58. Comparison of EU and US GMPs - Differences applying CFR211 or the EU GMPs
59. Correction Fluid on documents - FDA regulations?
60. FDA Validation - Does one have to conduct validation for Computer Servers?
61. IFU Font size - Specified by any regulations for medical devices on sale in the US?
62. IS there such a thing as FDA "Good Distribution Practices"
63. Can anyone provide me an audit checklist for 21 CFR Part 820?
64. ISO 15378:2006, Primary packaging materials for medicinal products
65. Canadian hospitals restrict the use of products that contain Lanolin?
66. Test Method Validation Help - New titration test method, not defined in the USP
67. Auditing Pharmaceutical Toll Manufacturers
68. Key Performance Indicators in a pharmaceutical company
69. FDA Requirements for Document Approval by Quality Department
70. cGMP and Batch Integrity of Bulk Storage Tanks
71. Pharmaceutical Company Quality Manual
72. Pharmaceutical & Validation Protocol Listings?
73. FDA Epoxy Floor Paint Specifications
74. 21 CFR Part 820 - in Chinese
75. Effective system to track a Technology Transfer to a sister plant
76. Permanent Inspection Readiness for a pharma manufacturing firm
77. OS Changes to Fielded (Validated) Medical System
78. Transitioning from ISO 9001 to CFR - Recently transferred to a Pharma company
79. DMR, DHR and DHF physical form
80. List of Approved Test Laboratories by FDA
81. ISO 13485 Similarities to 21 CFR Part 210/211 (Pharmaceuticals) for Quality systems
82. The most current version or draft of the Q10 - Pharmaceutical Quality Systems
83. Best practices for GMP training
84. What should generate a CAPA (corrective action - preventive action)
85. Blinding Checks for labels in a clinical study
86. Development of IOQ protocols - Validation in the pharmaceutical industry
87. OEM part number is listed in the Indications for Use Question
88. FDA holding toothpaste imported from China at Customs for testing?
89. EC11 - Guidance Document - FDA 510 (k) Submission - ECG Monitors
90. Initial Inspection of Medical Device Manufacturer
91. The differences between FDA and ISO 9001 Audits
92. Dried Food Packaging - Getting FDA registered / approved
93. Audit checklist for Cosmetics
94. FDA Audit next week
95. FDA warns on Hot Dog Chilli Sauce
96. Time for a Special 510k? Making a formulation change to an existing 510k
97. Signatures Requirements for Design phase documents
98. FDA warning on canned French Cut Green Beans
99. Approval - FDA and ISO Definitions
100. Humidity Requirements for an ISO 7 or ISO 8 Medical Device Cleanroom?
101. 510(k) after acquisition of other company
102. FDA Expands Warning on Eating Raw Oysters
103. Where to find 21 CFR 820 translated into German
104. Material Change - New 10993 Testing and Submitting a New 510(k)
105. What is the link between FDA and US Pharmacopeia?
106. Questions about cGMP in a pharmaceutical company in China
107. Customer is FDA Certified - Must we also be FDA Certified?
108. Date Stamping for Electronic signatures
109. Recognized Symbols for Device Labeling? 510k to the FDA
110. FDA Compliance - CMC quality and regulatory issues & cGMP - 21CFR parts 210 and 211
111. GIVE (Generic Initiative for Value and Efficiency) Launched by the FDA (US)
112. Requirements for Registering and Listing with the FDA
113. Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"
114. Liability for Packaged Drug products Sold Indirectly in the International Market.
115. Organizing Medical Device Requirements - How you carried out yours?
116. Applicable Guidelines for Use of Regrind Materials
117. Part 11 Requirements - Medical Devices vs. Pharmaceuticals
118. Is there such a thing as FDA Good Documentation Practice (GDP)?
119. Where can I find old 510(k)s (summaries)
120. Approximately $2 Million of Potentially Harmful "Cosmetic" Eye Product Seized
121. Status of Material Safety Data Sheet (OSHA Compliant) vs. 10993 Certificate
122. Statistical Analysis during Document Audit
123. Device History Record - Post Shipment - Class II Medical Device w/ embedded software
124. Requirements to Comply With FDA 21CFR820 For Invitro Diagnostic Device
125. FDA Launches Email Alert Subscription Service
126. Documentation and Record Requirement - What type of pen can be used? 820.180 Records
127. Incorporating the Use of a Specific Software in an SOP - Validation of QA Software
128. Obtaining Documents from the FDA in Frame of FOIA
129. Do we need to submit our memory foam oxygen mask gasket for FDA approval?
130. User Requirement Specification (URS) for off the shelf software.
131. Where to draw the line with Red Lining?
132. Process Validation needed with IDE Approval?
133. Risk Management Software suggestions?
134. DMR (Device Master Record) Revision Requirements? FDA GMP Manual
135. Design Plan TEMPLATE
136. How often does the FDA inspect organisations outside of the USA?
137. 21 CFR Part 11 Compliance - Generation of Complete Copies of Records
138. GTP (Good Tissue Practice) & GLP (Good Laboratory Practice) Certification
139. Customer Changes to Customer Supplied Documents - Testing Instructions
140. 510(k) Submission for Outsourced Automated Instrumentation System Components
141. Good Documentation Practice (GDP) - Actual Results (can they be typed)?
142. Part-11 Compliant Document Control & Integrated Training Software
143. FDA Requirements and/or Standard for Infant Formula Glucose Content
144. Specification Developer's 510K submissions
145. Production and Process Control SOP example or template needed
146. Process Validation - Production Line Transferring to a Different Facility
147. APEC Seminar on Harmonization of Medical Device Regulation (4-7, March)
148. FDA Proposes Guidance for Dissemination of Info on Unapproved Uses of Med Products
149. FWIW: FDA confused?
150. Does an ECG extension cable need a 510k?
151. Audit of Goods In as part of the QSIT "Production & Process Controls" Schedule
152. Tabular Gap Analysis of the EU (volume 4) and US (210/211) cGMP Regulations
153. Changes or Updates in FDA 21 CFR 820 content?
154. 21 CFR Part 11, "enforcement discretion" - Validation, Audit Trail, Record Retention
155. Can a prescription type material be used as a predicate for an OTC material?
156. Overall Residual Risk Procedure
157. Using Faxed Hand Signatures for Approval Records
158. Non-Dairy Creamer - Is there an FDA or other standard for Non-Dairy Creamers?
159. Defect Awareness Training - Medical Devices
160. FDA on path to establish offices in China
161. question on FDA and Health Canada
162. The new FDA internet home page - March 2008
163. Predicate Device - Question on Biocompatibility and IEC 60601-1 Testing Requirements
164. EU Validation Requirement vs. FDA Validation Requirement - EN 62304
165. Is there an FDA guidance on how to distinguish between Complaint and Repair?
166. Effects of substrate on biological indicator organisms
167. 510k Approval - Does the FDA look for Clinical Data
168. Has anyone had to do labeling/comprehension testing?
169. Performing Investigation of used returned expired devices
170. Company Develops Specifications - Manufacturing is Outsourced - Registration Question
171. Design Input - Question on Specific Performance Criteria for Medical Devices
172. The Benefits of 21 CFR Part 11
173. "Performance Specification" vs. "Specification"?
174. Reference to FDA on label or labelling
175. Calculation for Similarity and Differences in dissolution profile (F1&F2 Values)
176. 21 CFR parts 210 and 211 - CURRENT GMP FOR FINISHED PHARMACEUTICALS
177. 21 CFR Part 820 - QUALITY SYSTEM REGULATION
178. 21 CFR 201.66 Format And Content Requirements For OTC Drug Facts Labeling
179. List of Countries that require 'Certificates to Foreign Governments' (CFG)
180. USP (United States Pharmacopeia’s) Compliant Packaging Regulations & Process
181. FDA Embarks on Major Hiring Initiative for its Public Health Mission
182. ISO 13485 certified == cGMP compliance?
183. Email Exposure - Inappropriate statements uncovered in emails
184. Update DHF (Device History Record) when DMR (Device Master Record) changes?
185. Laboratory of Assay for Poliolefinas - Section 177.1520 of the FDA and AP89
186. SOP - Notification to Management of critical or major quality issues
187. Exhibition Equipment - What parts of 21CFR 820 apply to exhibition equipment?
188. Do we need FDA Approval of the Manufacturing Facility and how do you go about it?
189. Polymer/Material Specifications - Class 1 Medical Device
190. Do I need to perform design verification
191. Who is it manufactured by? Manufactured by vs. Manufactured for
192. CDRH Guidance Document - Software bugs submitted in 510(k): Quantity or Quality?
193. Oral Complaints - CFR 21 Section 820.198-(2) - Medical Devices
194. Rework vs. Reprocess - Definitions - Pharmaceuticals
195. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
196. Document Approvals and 21 CFR 11 - Electronic signatures and approvals
197. Control of Design Documents - FDA
198. Procedure on Traceability - FDA audit finding
199. Traceability of Requirements in the V-Model
200. Drug product physical properties stability studies - which properties to test?
201. Sterilzation Validation request for 510k
202. 510(k) FDA Memorandum #k97-1 and S & E decisions
203. Acceptance Activities-Dimensional Inspection was missed. Parts already assembled
204. FDA - "Net Quantity of Contents" - Manufacturing filling process
205. Device Listing - Format for listing number - What do the different prefixes mean?
206. When the FDA comes a knockin
207. 21 CFR Part 820 Consultant Question
208. When is ISO 10993 biocompatibilty qualification not needed?
209. Conflicts between multiple versions of IEC 60601 in regard to structural design...
210. California FDB (Food & Drug Branch) inspection experiences?
211. Is 21 CFR 820 Training Required?
212. Bulk Class II product sale to kit packers
213. FDA quantification of AQLs or Quality Levels
214. Medical Device User Fee Rates for 2009
215. Temperature and humidity storage requirements?
216. Autoclaving of Class I medical devices
217. Understanding FDA requirements for Software Validation
218. Confused - Medical Device Reports and Corrections/Removals