post market notification and approval(510)k

1. SES' R. C. Patel Institute of Pharmaceutical education & Research, SHIRPUR 1
GUIDED BY :-
Dr. P.P. NERKAR
PROFESSOR AND
HEAD OF RA DEPARTMENT
PRESENTED BY:-
Mr. Mayur Anil Patil
M.PHARM 1ST YEAR
MRA09
PREMARKET NOTIFICATION/APPROVAL
Department of Pharmaceutical Regulatory Affairs,
R. C. Patel Institute of Pharmaceutical Education & Research,
Shirpur.

2. SES' R. C. Patel Institute of Pharmaceutical education & Research, SHIRPUR 2
CONTENT
 PREMARKET NOTIFICATION (510K) DEFINITION
 PREMARKET NOTIFICATION PROCESS
 WHAT IS INCLUDED IN A510(K)?
 WHAT IS FDA PREMARKET NOTIFICATION?
 WHAT IS ARE THE DIFFERENCES BETWEEN PREMARKET APPROVALAND 510(K)?
 WHAT IS THE PURPOSE OF APREMARKET NOTIFICATION?
 PREMARKET APPROVAL (PMA) DEFINITION
 WHAT IS THE DIFFERENCE BETWEEN 510(K) AND PMA?
 WHAT GOES INTO A PMA?
 HOW LONG DOES A PMA TAKE?

3. SES' R. C. Patel Institute of Pharmaceutical education & Research, SHIRPUR 3
PREMARKET NOTIFICATION (510K) DEFINITION:-
Premarket notification (510k or PMN) refers to premarket submission made to the FDA to
demonstrate that a device can be marketed as safe and effective. Medical device
manufacturers must register to notify the FDA per section 510(k) of the Federal Food, Drug,
and Cosmetic Act at least 90days in advance of their intent to market a medical device.

4. SES' R. C. Patel Institute of Pharmaceutical education & Research, SHIRPUR 4

5. SES' R. C. Patel Institute of Pharmaceutical education & Research, SHIRPUR 5
WHAT IS INCLUDED IN A510(K)?
A 510(k) should include the following items:
• Classification of the medical device
• Predicate device(s)
• Device labelling
• Specifications (i.e. engineering, drawings, photos, etc.)
• Performance data such as clinical testing
• Sterilization information (if applicable)
• Guidance documents specific to the device type.

6. SES' R. C. Patel Institute of Pharmaceutical education & Research, SHIRPUR 6
WHAT IS FDA PREMARKET NOTIFICATION?
Device manufacturers must notify the FDA of their intent to commercialize a medical
device at least 90 days in advance, according to Section 510(k) of the Food, Drug, and
Cosmetic Act. Premarket notification (also known as PMN or 510(k)) is the term for this.

7. SES' R. C. Patel Institute of Pharmaceutical education & Research, SHIRPUR 7
WHAT IS ARE THE DIFFERENCES BETWEEN PREMARKET
APPROVALAND 510(K)?
Premarket approval (PMA) Is typically required for higher risk Class III medical devices. As
part of the PMA application, extensive scientific evidence in the form of laboratory and clinical
trial data must be submitted to demonstrate the safety and effectiveness of the device. Devices
in lower risk categories that do not require PMA will most likely require a 510(k)premarket
notification. The 510(k)is a faster and less expensive submission route that can be used if the
device is substantially equivalent to a device that is already cleared by the FDA.

8. SES' R. C. Patel Institute of Pharmaceutical Education & Research, Shirpur 8
WHAT IS THE PURPOSE OF APREMARKET NOTIFICATION?
A medical device producer must 'notify' the FDA 90 days before they intend to launch a new
or modified device under the premarket notification 510(k)process. The FDA can use this
notification to see if a device is substantially equivalent to one or more predicate devices.

9. SES' R. C. Patel Institute of Pharmaceutical education & Research, SHIRPUR 9
PREMARKET APPROVAL (PMA) DEFINITION:-
A premarket approval (PMA) is the most stringent type of device marketing application required by the
FDA. Submittal of a PMA is required by the FDA and is the process of scientific and regulatory review to
evaluate the safety and effectiveness of Class III medical devices. There are two main paths that medical
device manufacturer scan use to bring moderate- and high-risk devices to market with the FDA's
permission: through submittal of a PMA request or 510(k)application. A PMA is the more extensive
approach, requiring significant evidence that provides "reasonable assurance that the device is safe and
effective“ through methods like clinical trials. This process is reserved for high-risk Class III medical
devices.

10. SES' R. C. Patel Institute of Pharmaceutical education & Research, SHIRPUR. 10

11. SES' R. C. Patel Institute of Pharmaceutical education & Research, SHIRPUR 11
WHAT IS THE DIFFERENCE BETWEEN 510(K) AND PMA?
Premarket approval (PMA) is typically required for higher risk Class III medical devices. As
part of the PMA application, extensive scientific evidence in the form of laboratory and clinical
trial data must be submitted to demonstrate the safety and effectiveness of the device. Devices
in lower risk categories that do not require PMA will most likely require a 510(k) premarket
notification. The 510(k) is a faster and less expensive submission route that can be used if the
device is substantially equivalent to a device that is already cleared by the FDA.

12. SES' R.C. Patel Institute of Pharmaceutical education & Research, SHIRPUR 12
WHAT GOES INTO A PMA?
Separate sections on nonclinical laboratory studies and clinical investigations
involving human beings must be included in the PMA. All copies of the PMA
must include trade secrets or proprietary commercial or financial information.

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HOW LONG DOES A PMA TAKE?
The FDA's examination of a premarket approval application is
meant to take six months but it can, and often does, take longer.

14. SES' R. C. Patel Institute of Pharmaceutical education & Research, SHIRPUR. 14
REFERENCES:
https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k
https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances
https://www.sciencedirect.com/topics/engineering/premarket-notification
https://www.fda.gov/medical-devices/premarket-approval-pma/pma-application-contents
https://www.drugwatch.com/fda/premarket-approval/
https://www.arenasolutions.com/resources/glossary/premarket-approval/

15. SES' R. C. Patel Institute of Pharmaceutical education & Research, SHIRPUR 15
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