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A FDA 510k clearance or premarket submission demonstrates that the device which is marketed is safe and effective as predicate. The FDA 510k process is necessary to enter into the US market / or to sell your device in the US market. The FDA is responsible for authoring and enforcing the medical device quality system regulations (QSR), found in 21 CFR Part 820 of the Code of Federal Regulations. The FDA 510 k clearance process is the most common pre-market pathway for medical device companies. There are certain reasons due to which the 510k process gets delayed or the FDA 510k gets rejected, termed as FDA 510k clearance Barriers.
The barriers faced during the FDA 510(k) clearance process:
You might have designed a useful and wonderful product to manufacture but the first important thing is to get approval for the product or get the Clearance from FDA to market it. FDA I.e, Food and Drug Administration has set strict rules for medical device companies to market their product in the US. To commercialize the product manufacturer can follow the two ways first is premarket notification and the other is FDA 510(k). Premarket approval is needed for clinical and laboratory studies. The other path to commercialize your product is 510(k).
The majority of medical devices approved in the US are cleared through the 510(k)process. As an FDA 510(k) clearance process consultant we have guided and created a 510(k) dossier for many of them, which helped them in getting 510(k) clearance easily. Getting FDA 510(k) clearance is easy only if you submit the correct documents and follow proper guidelines.
Let’s check out some FDA 510(k) clearance barriers and solutions to overcome them.
- Wrong selection of Predicate Device.
- Device does not comply with specific requirement.
- Non-Technical Error.
- Errors in the review process.
Contact details –
Phone no - 93702 83428
Mail id – enquiry@operonstrategist.com
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Phone no - 93702 83428
Mail id – enquiry@operonstrategist.com
If You Want Medical Devices Services Consultation For Following.- Medical Device Consulting
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- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
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- DMF file submission guideline
- 21 cfr part 820
- qms certification services
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- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
- ce mark medical device
- CDSCO Manufacturing License
- CDSCO import license
- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
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