Definition Premarket Approval - What is a Premarket approval? Class 1 Medical Device

W

WBubel - 2010

#1
I need some clarification
What is a Premarket approval?
Does a class 1 device need a 510K or a premarket approval?

Thank you.
 
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chris1price

Trusted Information Resource
#2
Re: What is a Premarket approval?

Hi

Have a search through the FDA website (http://www.fda.gov/cdrh/devadvice/) to get more information.

PreMarket Approval (PMA)
"Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices." (http://www.fda.gov/cdrh/devadvice/pma/)

Premarket Notification - 510(k)
"Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9)." (http://www.fda.gov/cdrh/devadvice/314.html)

Most, but not all, Class 1 Devices are exampt from 510(k) or PMA requirements.

Chris
 

Ajit Basrur

Staff member
Admin
#3
Re: What is a Premarket approval?

Pre Market Approval (PMA) mostly applies for Class III medical devices that are high risk devices and pose a significant risk of illness or injury. The PMA process includes submission of clinical data to support claims made for the device and involves the formal approval of the FDA.

PMA involves approval of the safety and effectiveness of the medical device based on scientific data and rational, rather than just comparison as for the 510(k) or PMN process.

For Class I, General Controls may be sufficient.

You could also have a look at 21 CFR Part 814
 
Last edited:
C

CBAL08

#6
Thank you for the information.

However, when I open the PMA data base all it shows is the
detailed information that is needed to get into the database. I am very new to this matter and that is why need to see examples of PMA application cover letters (if possible).
 
C

CBAL08

#7
Thank you for the information.

However, when I open the PMA data base all it shows is the
detailed information that is needed to get into the database. I am very new to this matter and that is why need to see examples of PMA application cover letters (if possible).
have I asked something worng here??? Could anyone please help me regarding this issue. When I go to the PMA database as sugegsted. I do not have any idea what I get into. Please help.
 

Ajit Basrur

Staff member
Admin
#8
have I asked something worng here??? Could anyone please help me regarding this issue. When I go to the PMA database as sugegsted. I do not have any idea what I get into. Please help.
Nothing wrong CBAL08 - from that database, you could enter the applicant name.

For eg - if I enter BAXTER under Applicant Name, you can get all their products. Going inside it, if I click COSEAL SURGICAL SEALANT , it shows the info for that application. There is a link for Original PMA also.

This case was purely an example - you can find whatever info you want to look for. :)
 
C

CBAL08

#9
Nothing wrong CBAL08 - from that database, you could enter the applicant name.

For eg - if I enter BAXTER under Applicant Name, you can get all their products. Going inside it, if I click COSEAL SURGICAL SEALANT , it shows the info for that application. There is a link for Original PMA also.

This case was purely an example - you can find whatever info you want to look for. :)
Thank you so much for your help. I have now gained some idea that will be useful for me in future. Have been also reading the CFR 814 PMA of Medical Device, subpart B section 814.20- application. This provides quite an elaborated explanation of what must be included in the application process.

Thanks for your help once again.:thanks:
 
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