510K Clearance Application

B

brnsrmr

#1
I've created a web application and would like to market it. There are four pre-existing applications/devices and all of them are stand alone PC softwares. I have few questions I was wondering if someone can answer?

  1. Do I need a FDA 510K clearance for my web application?
  2. I have called around the companies that help with these applications but they ask around 20K, Does that sound reasonable?
  3. I don't have and can not afford 20K, can I submit the application myself?
  4. Any other alternatives?
Thanks in advance.
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
1. That depends on whether it's a medical device, and if so, what class it's in. Have you reviewed http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm, and if so, what were your conclusions and why?

2. The cost for doing the work to get a 510(k) depends considerably on the nature of the product and on how much of the work is done by the applicant...which depends on their knowledge of their product and the regulations. $20K is reasonable at some point in that continuum.

3. You certainly could prepare a 510(k) application yourself, but you would have to know considerably more than the questions you're asking imply that you know at present.

4. Maybe your device is Class I (no premarket clearance required) or Class III (PMA instead of 510[k], and if you can't afford $20K, you certainly can't afford to market a Class III device.) Figure out the basics before you start asking more complex questions about how to take subsequent steps.

Marketing of Class II medical devices does not lend itself to minimally resourced operations.
 
Thread starter Similar threads Forum Replies Date
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
N Traditional 510K Submission-Financial Certification or Disclosure Statement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
P Letter to file or special 510k or traditional 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Y 510k requirement for bringing in gloves Medical Device and FDA Regulations and Standards News 0
G Special 510K possible? Only the packaging has changed Other US Medical Device Regulations 0
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
H 510k with Contract Manufacturer Other US Medical Device Regulations 2
K FDA 510k electrosurgery 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
K 510K new manufacturer but same components Other US Medical Device Regulations 6
S Two or more predicates suitable? 510K submission US Food and Drug Administration (FDA) 5
S 510k: What to include if your own device is the predicate US Food and Drug Administration (FDA) 5
L 510K - Trade Name Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
R Countries that accept 510k approvals - Class II nonsterile medical device Other Medical Device Regulations World-Wide 2
M Timing of 510k submission Other US Medical Device Regulations 9
S Examples of software changes that required a 510k US Food and Drug Administration (FDA) 2
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
Ronen E Can anyone please explain this? (510k submission requirement) Other US Medical Device Regulations 14
H New 510K VS Documents about design change. Other US Medical Device Regulations 1
P Medical Device not on commercial distribution but installed in the establishment. 510k? Other US Medical Device Regulations 10
V Presubmission FDA for 510k US Food and Drug Administration (FDA) 4
A How to deal with changed shared components in 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Can we take a part from 510k cleared medical device and use it in class I device? Other US Medical Device Regulations 3
D Contents of a 510k Q submission Other US Medical Device Regulations 1
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
Ed Panek Other company wants to use our FDA 510K bundled with their product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
L 510k exemption process - Do you still need to submit technical dossier? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S IEC 62133 - CB Scheme Required by FDA 510k Other Medical Device Related Standards 3
S The key differences in 510k types - Traditional vs. Abbreviated vs. Special US Food and Drug Administration (FDA) 0
P V&V for Special 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Clarity on requirements for a 510k exempt Class I device - Suture removal kit US Food and Drug Administration (FDA) 9
T Is 510k Anesthesia group particularly picky/difficult to work with during 510k? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J 510k - Product shelf life validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K 510K statement Questions 21 CFR 807.93 - Discontinued or never released for sale US Food and Drug Administration (FDA) 0
J Applying for 510K - What is a significant process change and what is not US Food and Drug Administration (FDA) 5
K 510K Interactive Review 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Celsius and Fahrenheit in 510k US Food and Drug Administration (FDA) 4
R FDA 510K - Does the FDA accept the testing report from other countries? Other US Medical Device Regulations 1
I 510k Performance Testing Studies (Raw Data) - What does the FDA expect 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Is a different 510k is required for each (stand alone) software configurations? Other US Medical Device Regulations 3
K ISO 10993 Requirements For 510k - Substantial Equivalence Other US Medical Device Regulations 11
P Two separate 510k submissions for one device from the same company Other US Medical Device Regulations 10
I Special 510k Imported Legacy Blogs 0
K 510k "Premarket" Submission for Existing Class II Software Medical Device US Food and Drug Administration (FDA) 3
N Is a new 510K required for change of manufacturing location for an existing device? US Food and Drug Administration (FDA) 1
Q 510k Submission for a New Medical Device Product Other US Medical Device Regulations 3
W New 510k required for a material change? Other US Medical Device Regulations 9
M What if information in predicate 510k is obviously wrong? Other US Medical Device Regulations 5
E 'Special' 510k as a Predicate Medical Device? Other US Medical Device Regulations 3
A Does anyone have experience providing a summary of Pre-IDE discussions in the 510k US Food and Drug Administration (FDA) 1

Similar threads

Top Bottom