sagai
Quite Involved in Discussions
only some minor observations
510k is the Act itself (and when you do so, you legally bind yourself to the Act with its all consequences), see: FD&C Act Sec.510(k)
http :// www .fda. gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm109201.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED
Relevant amendments can be also found here:
http :// www .fda. gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED
There are some more consequential Acts and Amendments, like:
Safe Medical Devices Act of 1990
Congress.gov | Library of Congress
Medical Device Amendments of 1992
Congress.gov | Library of Congress
510k premarket notification procedure is defined by FDA as part of the execution of the corresponding Act, see:
The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance
510k, premarket notification procedure is NOT the same as premarket approval, its based on your device classification (I am not going such deep).
More reading for marketing the Medical Device in the US and for premarket notification (510k), see:
How to Study and Market Your Device
Premarket Notification 510(k)
For SW contained in medical device there is a reading here:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm
In general and introductory learning and investigation, I hardly suggest these materials also and of course, PASS THE TESTS !!!
:
http :// www .fda.gov/Training/CDRHLearn/ucm162015.htm#510k - OBSOLETE BROKEN 404 LINK(s) UNLINKED
As we can see and may know, only a premarket notification (510k) is fairly complex procedure can be for an applicant and requires a LOT of knowledge and preparation in order to be successful.
Regarding "quality procedure and process" the FDA GMP in this context is 21CFR820, see:
CFR - Code of Federal Regulations Title 21
Furthermore ...
510k, the Act requires to comply with:
- registration and listing (21CFR807)
- labeling (21CFR801 , 21CFR809)
- medical device reporting (reporting medical device-related adverse events) (21CFR803)
without a complete list.
see these using:
CFR - Code of Federal Regulations Title 21
about the standards ...
There are recognized and NOT recognized standards in FDA.
to read more, see:
Standards and Conformity Assessment Program
and to search for:
Recognized Consensus Standards
62304:
Recognized Consensus Standards
The RM in 62304 does not enough alone, and actually 62304 declares it implicitly, see in the Introduction of 62304 saying:
"
The RISK MANAGEMENT PROCESS is already very well addressed by the International
Standard ISO 14971. Therefore IEC 62304 makes use of this advantage simply by a normative reference to ISO 14971.
"
"
The software RISK MANAGEMENT PROCESS required in this standard has to be embedded in the device RISK MANAGEMENT PROCESS according to ISO 14971
"
Moreover in 62304 the 14971 is a NORMATIVE REFERENCE, see Chapter 2 in the standard.
okay, that's all, br
Sz.
510k is the Act itself (and when you do so, you legally bind yourself to the Act with its all consequences), see: FD&C Act Sec.510(k)
http :// www .fda. gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm109201.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED
Relevant amendments can be also found here:
http :// www .fda. gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED
There are some more consequential Acts and Amendments, like:
Safe Medical Devices Act of 1990
Congress.gov | Library of Congress
Medical Device Amendments of 1992
Congress.gov | Library of Congress
510k premarket notification procedure is defined by FDA as part of the execution of the corresponding Act, see:
The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance
510k, premarket notification procedure is NOT the same as premarket approval, its based on your device classification (I am not going such deep).
More reading for marketing the Medical Device in the US and for premarket notification (510k), see:
How to Study and Market Your Device
Premarket Notification 510(k)
For SW contained in medical device there is a reading here:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm
In general and introductory learning and investigation, I hardly suggest these materials also and of course, PASS THE TESTS !!!
:http :// www .fda.gov/Training/CDRHLearn/ucm162015.htm#510k - OBSOLETE BROKEN 404 LINK(s) UNLINKED
As we can see and may know, only a premarket notification (510k) is fairly complex procedure can be for an applicant and requires a LOT of knowledge and preparation in order to be successful.
Regarding "quality procedure and process" the FDA GMP in this context is 21CFR820, see:
CFR - Code of Federal Regulations Title 21
Furthermore ...
510k, the Act requires to comply with:
- registration and listing (21CFR807)
- labeling (21CFR801 , 21CFR809)
- medical device reporting (reporting medical device-related adverse events) (21CFR803)
without a complete list.
see these using:
CFR - Code of Federal Regulations Title 21
about the standards ...
There are recognized and NOT recognized standards in FDA.
to read more, see:
Standards and Conformity Assessment Program
and to search for:
Recognized Consensus Standards
62304:
Recognized Consensus Standards
The RM in 62304 does not enough alone, and actually 62304 declares it implicitly, see in the Introduction of 62304 saying:
"
The RISK MANAGEMENT PROCESS is already very well addressed by the International
Standard ISO 14971. Therefore IEC 62304 makes use of this advantage simply by a normative reference to ISO 14971.
"
"
The software RISK MANAGEMENT PROCESS required in this standard has to be embedded in the device RISK MANAGEMENT PROCESS according to ISO 14971
"
Moreover in 62304 the 14971 is a NORMATIVE REFERENCE, see Chapter 2 in the standard.
okay, that's all, br
Sz.
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