The Elsmar Cove Forum > National and International Business Standards > FDA (United States Food and Drug Administration) > Medical Devices (21 CFR part 820)

1. Could we get FDA approval just for subsystem - FDA approved medical device
2. ISO 13485 - Part 11: Electronic Records - Small Biotech Company - What is required?
3. FDA vs. Materials requiring Refrigeration - Dental adhesives
4. New Japanese EMC/electrical safety standards - Additional product testing required?
5. FDA Quality Plan - Document Management Responsibility, section 820.20 d
6. Statistical Techniques in Research - Application of 820.250
7. FDA - Design Control Forms - Medical devices (Class I and II
8. Documents / Following Procedures - FDA 21 CFR Part 820 Quality System Regulation
9. FDA 510(k) required? US company private labeling a FDA class II device
10. Labeling and advertising - Advertising claims made by Distributors - Medical devices
11. Labeling of Medical Devices - Distributor replacing device serial number label
12. Medical device class 1 Complaint investigations
13. Sec. 820.120 Device Labeling & DHR - Count and Document All Labels
14. Concession Procedure FDA Guidelines - medical devices.
15. Federal Warning on Packaging - Both the inner and outer packaging? Class I Medical
16. New FDA Forms - 2891 Registration of Device Establishment, FDA 2892 Device Listing
17. Control without blueprints - Sewing department - Medical Devices
18. FDA 21 CFR 820.90 - Nonconformance and Device History, and Rework Records
19. 21CFR820-820.50 Purchasing controls - Using Non-Approved Suppliers
20. FDA Annual Registration - Any harm to be FDA (form FDA 2891a) registrated
21. FDA requires 7 Years of Support? UL 544 for Extended Support? End of Life of Product
22. CFR Title 21 820.72.b accuracy and precision
23. New format for 510(k)'s - Guidance document from the FDA
24. Use of Declaration of Conformity in Traditional 510(k)???
25. Temperature indication In Vitro Medical Devices USA
26. QSR Training - I am looking for a new QSR training program
27. Has anyone ever had to submit a DMF (Drug Master File) with the FDA?
28. FDA approval required for a supplier to a medical device manufacturer?
29. IFU Font size - Specified by any regulations for medical devices on sale in the US?
30. Can anyone provide me an audit checklist for 21 CFR Part 820?
31. 21 CFR Part 820 - in Chinese
32. OS Changes to Fielded (Validated) Medical System
33. DMR, DHR and DHF physical form
34. FDA Medical Device Audit Checklist.
35. OEM part number is listed in the Indications for Use Question
36. EC11 - Guidance Document - FDA 510 (k) Submission - ECG Monitors
37. Initial Inspection of Medical Device Manufacturer
38. Time for a Special 510k? Making a formulation change to an existing 510k
39. Humidity Requirements for an ISO 7 or ISO 8 Medical Device Cleanroom?
40. 510(k) after acquisition of other company
41. Where to find 21 CFR 820 translated into German
42. Material Change - New 10993 Testing and Submitting a New 510(k)
43. Recognized Symbols for Device Labeling? 510k to the FDA
44. Requirements for Registering and Listing with the FDA
45. Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"
46. Organizing Medical Device Requirements - How you carried out yours?
47. Applicable Guidelines for Use of Regrind Materials
48. Where can I find old 510(k)s (summaries)
49. Device History Record - Post Shipment - Class II Medical Device w/ embedded software
50. Requirements to Comply With FDA 21CFR820 For Invitro Diagnostic Device
51. Documentation and Record Requirement - What type of pen can be used? 820.180 Records
52. Do we need to submit our memory foam oxygen mask gasket for FDA approval?
53. Process Validation needed with IDE Approval?
54. DMR (Device Master Record) Revision Requirements? FDA GMP Manual
55. 510(k) Submission for Outsourced Automated Instrumentation System Components
56. Specification Developer's 510K submissions
57. APEC Seminar on Harmonization of Medical Device Regulation (4-7, March)
58. Does an ECG extension cable need a 510k?
59. Audit of Goods In as part of the QSIT "Production & Process Controls" Schedule
60. Changes or Updates in FDA 21 CFR 820 content?
61. Defect Awareness Training - Medical Devices
62. 510k Approval - Does the FDA look for Clinical Data
63. Performing Investigation of used returned expired devices
64. Company Develops Specifications-Manufacturing is Outsourced-Registration Question
65. 21 CFR Part 820 - QUALITY SYSTEM REGULATION
66. ISO 13485 certified == cGMP compliance?
67. Update DHF (Device History Record) when DMR (Device Master Record) changes?
68. Exhibition Equipment - What parts of 21CFR 820 apply to exhibition equipment?
69. Polymer/Material Specifications - Class 1 Medical Device
70. CDRH Guidance Document - Software bugs submitted in 510(k): Quantity or Quality?
71. Oral Complaints - CFR 21 Section 820.198-(2) - Medical Devices
72. Control of Design Documents - FDA
73. Sterilization Validation request for 510k
74. 510(k) FDA Memorandum #k97-1 and S & E decisions
75. Acceptance Activities-Dimensional Inspection was missed. Parts already assembled
76. Device Listing - Format for listing number - What do the different prefixes mean?
77. 21 CFR Part 820 Consultant Question
78. When is ISO 10993 biocompatibilty qualification not needed?
79. Is 21 CFR 820 Training Required?
80. Bulk Class II product sale to kit packers
81. FDA quantification of AQLs or Quality Levels
82. Medical Device User Fee Rates for 2010
83. Autoclaving of Class I medical devices
84. Confused - Medical Device Reports and Corrections/Removals
85. Risk Management for Class I Medical Devices?
86. What are the requirements of traceability in FDA's Regulations
87. FMEA vs. Hazard Analysis per FDA interpretation
88. Biocompatibility of Lexan 244 - Is anyone using Lexan 244?
89. Change in FDA Establishment Registration Fee process wef Oct 1, 2008
90. When to submit a new FDA Device Listing
91. Application for special 510(k) - What are the documents to submit to FDA?
92. Continuous Spinal Infusion Investigational Device Exemption
93. Market application of ISO PB70:2003?
94. ISO/ANSI/AAMI PB70:2003 and EN13795
95. FDA regulations for medical devices distributor in US
96. Harmonization of device classification with EU MDD?
97. Protocol Agreement - PMA application for Class III Medical devices
98. Date stamp on documents from production - Medical Devices
99. Device Master Record (DMR) that was compiled by another company
100. FDA issued new Guidance for Ultrasound Diagnostic Devices.
101. FDA's view on Wiki's for users to find equipment operation procedures
102. GHTF, next-gen MDD...headed in the same direction?
103. GMP Question for Polyethylene Drum Faucet - Class I Medical Device
104. Is this legal - Selling all the family products in one 510(k)?
105. FDA Class III Medical Device Modification - 510k Application
106. Medical Device Reporting - MDRs for incidences outside the US
107. Can a CSA-US certificate substitute a FDA 510(k) clearance?
108. Device Class when used in combination with a device of a higher class?
109. PMA (PreMarket Approval) Check List example wanted for Class III Medical Device
110. Format of Device Master Record (DMR) for Combination Products
111. FDA product Labeling Question - Re-selling and Re-labeling
112. Characteristics of predicate device for 510(k)
113. Plastic film materials that will meet both USP and SP?
114. Only appearance and PCB are changed - Do we need to submit a new 510(k)?
115. Ownership of FDA registered establishment changing - what to do?
116. Existing Device + Existing Device = OK ? New 510(k) required?
117. What would the FDA expect to see when they ask for our QSR?
118. PMA (Premarket Approval) - Will inspection of Component Manufacturers occur?
119. FDA approval (Med Device) - Should we use Accredited Person or proceed on Our Own?
120. 21 CFR 820 - Missing Numbers - I have a reference to 820.84
121. Question regarding Device Master Records & Specification Developers
122. Only the FDA can sell in USA - Class II medical device
123. Share 510(k)s with our owner/operator??
124. Latex Free if it comes in contact with a material containing latex?
125. Major differences between 21 CFR Part 820 and ISO 13485?
126. Latest EU 76/768/EEC Directive
127. Contract Manufacturer must adhere to 21 CFR 820 - Can FDA require us to do this?
128. FDA Under Pressure From Congress - Impact on pending 510(k)'s
129. Handguns are now FDA Class I medical devices....
130. Design control documentation provided in special 510(k) + FDA response
131. Timing on 510(k) filing - New medical device
132. FDA classifying all PACS software devices as Moderate Level of Concern?
133. 21 CFR 820 - Stability and Validation Requirements
134. 510(k) submission - Questions about page 2 of form 3654
135. Legal and clinical conditions for defining Prescription-only devices
136. Harmonization of ANSI/AAMI PB70:2003, EN 13795?
137. Transfer Investigational Device Exemption (IDE) to New Sponsor
138. The GAO report on the 510(k) process
139. FDA Unique Device Identifiers on the labeling of devices
140. Can I submit a 510(k) without aging data?
141. Cal 133 flammability standard - Medical Devices - Stupid Customer Tricks
142. Circuit Board Incoming Inpection Criteria
143. 510(K) for ptosis sling - What is 510(K) exempt?
144. Transparency / Reciprocity - Medical device incident reported in the EU
145. When to submit a 510(k) for a change to an exisiting medical device
146. Classification of device - frontalis suspension sling
147. Pet dog in medical device facility?
148. Probably going to get an APIP (Accredited Persons Inspection Program) inspection
149. FDA Registration - How to renew our registration for medical devices to FDA?
150. FDA Risk Management vs. CE Risk Management - Requirements Differences
151. Demonstrating substantial equivalence - Requesting 510(k) data from company
152. How to establish a Design History file (DHF)?
153. Australian Medical Device Database like the US FDA's 510(k)
154. Does a Company have to appoint a US Agent to sell product in Canada or vise versa?
155. The FDA says device regulation will move toward harmonization...
156. FDA CAPA Requirement for Contract Med. Dev. Manufacturers
157. 510(k) timing from submittal to FDA approval
158. Class II medical device manufacturing
159. DHF (Design History File) Template
160. FDA & Recall (voluntary) - Relabeling devices from a different distributor
161. Regulations for Yield Reporting and Evaluation Upon Lot Completion
162. Questions about the "change control procedure" in FDA's QSR manual
163. QSR 820.120 labeling and packaging control
164. Document Controls - Input and Ideas - Small medical devices company
165. IFU (Instruction for use) requirements in Final Package of Class I and II device
166. Spinal Implant Testing Requirements - Bioburden, TGA & Ion Chromatography
167. Accelerate the possesing of ISO 13845 and CAN/CSA-certifications a FDA registration
168. Refurbished class 2 medical device which were returned because of 'Customer Remorse'
169. 510k for Exempt Class I Medical Device - Industry Advantage to having a 510k Approval
170. FDA - Registration & Listing Updating +
171. 510k submission for class II medical device
172. DHR (Device History Record) for Medical Device Software
173. Register, list and pay the Device Facility User Fee with FDA
174. FDA: File an electronic Registration of Drug Establishment/Labeler Code
175. Antimicrobial surface coatings - FDA OAP, Office of Antimicrobial Products
176. Classification of a Medical Device in FDA
177. FDA Audit - who is "eligible"? Medical Device Sub-Contract Manufacturer
178. 510(k) Issuance & Warning Letter - to spec. developer or contract manufacturer?
179. Risk of Bodily Harm - Warning vs. Caution Statements on Medical Device Labeling
180. Will FDA check the 510(k) files in field inspection?
181. Topical Anesthetic for Dental use - Where to start to get it registered?
182. International Manufacturing Facility Audit
183. 510(K) for an entire system vs. separate 510(K) for each sub-system
184. When to File an MDR (Medical Device Reporting) For Incidents in Foreign Countries
185. Classification of a disposable Screen Pointer for use by surgeons on monitors?
186. Link to find 502 (f)(1) which is quoted several times in 21 CFR 820
187. Apply one 510(k) for both surgical and therapy laser?
188. FDA Packaging Test Requirements - Product is PE Bag
189. Classification of the medical device code and 'subsequent' code
190. Device marketed by someone else & different name...is a 510(k) required?
191. Quality System for Multiple Facilities
192. IDE vs NSR for Class II medical device clincal trial?
193. Does European Manufacturer with ISO 13485 need QSR820 for FDA registration?
194. FDA requirement for Minimum Font or Type Size for Labelling
195. Purchasing contract clauses -spec developer/contract manufacturer/initial distributor
196. Japan - Shonin question - Delay if Contract Manufacturer Moves? Medical Devices
197. The warning letter of ONBO - Why FDA require identification of 510(k) ownership?
198. FDA Issues Final Regulation on Dental Amalgam
199. Do I need submit a traditional 510(k) or Abbreviated 510(k)
200. USFDA Audit - Share your experience
201. Questions about FDA registration and 510k application
202. Differences between 510k (Premarket notification) & Registration and Listing
203. Device History Record - Single file for each lot with all the lots history?
204. The blood glucose monitor test strips can be sold seperately or not?
205. Physician Documentation System vs. Electronic Medical Record
206. What class are Syringe Pump and Infusion Pump?
207. COA (Certificate of Analysis) issued from supplier - His name or mine?
208. Info needed for a 510k of a high-pressure line? Especially Design Controls
209. Regulation on Residue Level on Medical Device
210. Do we have to submit a new 510(k) for a device with a new MCU?
211. Good Importer Practices - Draft Guidance
212. Submitting a 510(k)-the cuff individually or the system
213. Do I have to update the FDA10(k) files when there is a new standard?
214. What is "Design Input" by QSR, 21 CFR Part 820 ?
215. FDA Guidance document - User Fees and Refunds for 510(k) submissions
216. Do ALL Quality Records Require Approval?
217. Pre Filled Syringes (PFS) - Effect of Containers on the Contents
218. US FDA's updated Consensus Standards List - 18th March 2009
219. Classification of Surgical Sutures used for Cardiovascular Surgery
220. Medical Device Reporting procedure - Correction and Removal (21 CFR 806)
221. Is more than one Product Code allowed in a 510(k) application?
222. Design History File (DHF) Maintenance Information wanted
223. Is it Legal for Printing CE Mark in Label? FDA Aspect
224. "Application Correspondent" in the CDRH Review Cover Sheet - What does mean?
225. Establishment Register Question - Subcontracting - Blood Glucose Monitor System
226. Nonconforming Material Control - Gap in the Control of Non-Conforming Materials
227. Proposed documents from GHTF (Global Harmonization Task Force)
228. 510(K) Premarket Notification Approval for Cardiovascular Class II Medical Device
229. Is Foreign Exporter required to submit a 510(k)?
230. US FDA Guidance on Medical Device Establishment Registration and Listing
231. The relationship between OEM and the subcontracted manufacturer
232. 510k Submission Samples - Class II Medical Device - Knee Joint Prosthesis
233. Design Trace Matrix Ensuring that Design Outputs meet Design Inputs wanted
234. ISO 13485, ISO 14971 and other Medical Device Related Forums
235. When to Submit a 510(k) in the Product Life Cycle
236. Used Parts in Medical Devices - Opinions on Servicing and Repair
237. Research Use Only Medical Device - Standalone software product
238. Corrective and Preventive Action (CAPA), 820.100
239. Storage distance between flammable & non-flammable goods - guidelines/standards?
240. Deciding what Processes need Control and Monitoring - 820.70
241. Remediating a Design History File (DHF) for an IVD developed prior to 1997
242. Question about who should register the foreign medical device establishment
243. Other observations During the CAPA process.
244. When to issue a Class II Device Recall (failure not harmful nor a safety issue)
245. 510(k) Ownership Change - Is it painful or is it a pretty easy process
246. 510(k) Submitter Name Change question - Only the name of the company is changed
247. Sale of Demonstration Units - how should we document it from GMP standpoint?
248. Software Validation - Splitting the Level of Concern on multiple software parts