Submit a Special 510(k) or "Documentation by our own"

B

bennylee

#1
Dear All,

For some of products (that we have got 510k),
now, we want to slightly change some specification (device modification without any change in safety & intended for use & contraindication),
I just worry if I need to apply through
  • Special 510(k)
  • Documentation by our own (such as comparison & related test report )

Based on the following documentation #K97-1
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080235.htm
, it seems that Documentation by our own is fine

Based on the following documentation "The New 510(k) Paradigm"
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080187.htm
, it seems that special 510k is required.

Thanks !
 
Elsmar Forum Sponsor
B

bennylee

#3
Thanks for your reply !

Yes, I have 510(k) for the original version.

For this modification version, it seems that Special 510(k) is also applicable to our situation, so I am still confused.
"The Special 510(k) option will allow the Agency to review modifications that do not affect the device's intended use or alter the device's fundamental scientific technology within this abbreviated time frame.

Can I consider that "Special 510(k) is an optional, not mandatory for device modification ( without any change in safety & intended for use & contraindication) "?
 
T

treesei

#5
Thanks for your reply !

Yes, I have 510(k) for the original version.

For this modification version, it seems that Special 510(k) is also applicable to our situation, so I am still confused.
"The Special 510(k) option will allow the Agency to review modifications that do not affect the device's intended use or alter the device's fundamental scientific technology within this abbreviated time frame.

Can I consider that "Special 510(k) is an optional, not mandatory for device modification ( without any change in safety & intended for use & contraindication) "?
Here is my understanding:

You first determine if your modification needs a new 510k using K97-1. If the answer is yes, you use the New 510K final guidance to determine which kind of 510k you can use. Under some circumstances, a modification still leads to a 510k (vs documentation) even it does not change the device's intended use, safety, technology, etc.
 
I

isoalchemist

#6
Agree with treesei, first you need to walk down and document your decisions based on the K-97-1.

If documentation is all that's required make sure you have it.

If a 510k is required from the analysis you can then walk down the type of 510k to file. Be critical to make sure you meet the Special 510k criteria, the FDA will. Depending on the specification changes it may or may not be an issue.
 
Thread starter Similar threads Forum Replies Date
J Can we submit data with Special 510(k)? US Food and Drug Administration (FDA) 8
B Deciding when to submit a Special 510(k) US Food and Drug Administration (FDA) 10
C Application for special 510(k) - What are the documents to submit to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Do we need to submit Special 510K for a Blood Glucose System? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
F How to submit PPAP without IMDS APQP and PPAP 10
M Informational TGA presentation: How to submit an effective good manufacturing practice clearance application Medical Device and FDA Regulations and Standards News 0
Watchcat EU Certification - What do you submit to an NB EU Medical Device Regulations 5
B Submit a 510(k) with a Predicate cleared but not Listed US Food and Drug Administration (FDA) 9
L Reasons to submit a new PPAP or notify the customer APQP and PPAP 3
L 510k exemption process - Do you still need to submit technical dossier? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
N How to deal with catalog parts suppliers who refuse to submit PPAP documents? APQP and PPAP 0
I Where to submit Adverse Events Reports in Europe EU Medical Device Regulations 7
B Should I Request/Submit a PPAP from/to a Supplier/Customer for only Repackaging Parts APQP and PPAP 7
Ronen E FDA releases new draft guidance on when to submit a 510(k) for device modification Other US Medical Device Regulations 10
L 20 days to submit PPAP APQP and PPAP 9
A Using Regulations.gov to Submit Comments on FDA Guidance Documents Other US Medical Device Regulations 5
E When to submit a Technical File for a Class IIb Medical Device EU Medical Device Regulations 3
D Customer will not submit Purchase Orders - System for ISO 9001 Compliance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
L Can we submit an AS9102 if we are not AS9100 certified? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
S Guidance to prepare and submit a Level 3 PPAP to a Customer APQP and PPAP 6
I Where do we submit the FAA Preapplication forms? Federal Aviation Administration (FAA) Standards and Requirements 1
O Medical Device Registration in EU - Which Ministry to submit Technical File? EU Medical Device Regulations 9
S How to Submit ISO/TS 16949 & ISO14001 Certificates to HMMA IATF 16949 - Automotive Quality Systems Standard 4
W Submit MDR for a device cleared by FDA but not sold in US? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Part Submission Form - Need to submit PSW only once? APQP and PPAP 5
M If I update a DFMEA do I need to submit to my Customer? FMEA and Control Plans 7
C When to submit a 510(k)? After the DMR (Device Master Record) is finished? Other US Medical Device Regulations 4
A Should I submit the entire copy of my software in a 510(k) submission?? US Food and Drug Administration (FDA) 7
Howard Atkins Is there a time frame for CBs to submit the TS 16949 Audit Report? Registrars and Notified Bodies 2
J What is the time limit for an auditor to respond to NCR's and submit audit report? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
shimonv Deciding When to Submit a 510(k) for a Change to an Existing Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
sagai New Draft Guidance - When to Submit a 510(k) for a Change to an Existing Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S How to locate a Sponsor in Australia to submit Product Approval Applications by TGA Other Medical Device Regulations World-Wide 3
R In 510k application do we submit documents showing compliance with 21CFRPart820 Other US Medical Device Regulations 12
P Does our company need to be certified in order to submit a 510k Other US Medical Device Regulations 4
C How to Submit an Expansion of Claims 510(k)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
A Before the ISO-9001 certification audit can we submit the documents to our customer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
N Can I submit 510(k) without Biocompatibility Test Results? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C When to Submit a 510(k) in the Product Life Cycle 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
W Is Foreign Exporter required to submit a 510(k)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Do we have to submit a new 510(k) for a device with a new MCU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
E Do I need submit a traditional 510(k) or Abbreviated 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
N Supplier PPAP - How many parts should they submit? APQP and PPAP 6
C When to submit a 510(k) for a change to an exisiting medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 29
A What is PPAP (Production Part Approval Process) Why submit it and/with PSW APQP and PPAP 2
P Can I submit a 510(k) without aging data? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C Only appearance and PCB are changed - Do we need to submit a new 510(k)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R When to submit a new FDA Device Listing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5

Similar threads

Top Bottom