Pepgra pros answer important queries pertaining to FDA 510(K)
Pepgra CRO experts answer common, yet important queries pertaining to FDA 510(k) approval.
Query# 1: Will I receive a 510(k) clearance letter?
Yes, FDA will issue a 510(k) clearance letter and post it on their website; however, you will not receive a registration certificate after 510(k) clearance. The formal proof stating your clearance is the one posted on the web site by FDA.
Query# 2: What do you mean by family of devices? Is a single submission possible for products?
You can do a “grouping” for a single submission for medical devices that have the same FDA classification; however, within a single 510(k), medical devices with varying codes may also be submitted if they are purposed to be used together to perform the intended use of the device family.
Query# 3: What happens if 510(k) is transferred?
If you (device manufacturer) submit the 510(k) then you are considered the owner of 510(k); however, the actual device maker may differ. In case your company is purchased/acquired, then the purchaser must notify the FDA of the new ownership and complete the transfer of 510(k). Suppose there is a change in the location of the device manufacturing facility, then processes must be verified at the new facility as per the Quality Management System (QMS). You must register the new site location with FDA as well.
Query# 4: Do I have to do the same testing if there is a predicate?
You must do comparative testing of equivalence on a predicate device. The results must support your product’s equivalence in relation to the predicate device.
Query# 5: What is the validity of 510(k)?
The validity of 510(k) holds good until you make modifications to the product, purpose of usage, or indications for use. If you make any changes then ascertain if they require a new FDA submission.
Query# 6: For non-US devices, do I need to get native country’s approval?
No. The native country approval is not necessary to get FDA approval.
Talk to Pepgra CRO experts today for getting an FDA approval.
Pepgra is a leading CRO solutions for medical device manufacturers with offices across US, UK and India. Pepgra CRO experts offer assistance in all phases of clinical trials. Clinical research, regulatory affairs, regulatory writing, medical writing, Clinical Trial Protocols (CTP), biostatistical programming, trial patient monitoring, and Post-marketing Surveillance (PMS)—these are some of our offerings with niche therapeutic offerings as a key differentiating factor. Partner with Pepgra today; your reliable CRO partner. www.pepgra.com | +1-972-502-9262 | sales@pepgra.com
Do you have more questions on 510(k)? Talk to Pepgra experts today.
Pepgra is a leading CRO solutions for medical device manufacturers with offices across US, UK and India. Pepgra CRO experts offer assistance in all phases of clinical trials. Clinical research, regulatory affairs, regulatory writing, medical writing, Clinical Trial Protocols (CTP), biostatistical programming, trial patient monitoring, and Post-marketing Surveillance (PMS)—these are some of our offerings with niche therapeutic offerings as a key differentiating factor. Partner with Pepgra today. Your reliable CRO provider.
