510(k) submission’s mandatory sections that you cannot do without
Here is a list of sections that are required for an FDA 510(k) submission.
Group I: Cover sheet forms
- a) Section 1.0 – Medical Device User Fee Cover Sheet (Form FDA 3601)
- b) Section 2.0 – CDRH Premarket Review Submission Cover Sheet
Group II: What will they see?
- a) Section 3.0 – 510(k) Cover Letter
- b) Section 4.0 – Indications for Use Statement
- c) Section 5.0 – 510(k) Summary
Group III: Templatized Sections
- a) Section 6.0 – Truthful and Accuracy Statement
- b) Section 7.0 – Class III Summary and Certification
- c) Section 8.0 – Financial Certification or Disclosure Statement
- d) Section 9.0 – Declarations of Conformity and Summary Reports
Group IV: Comparing your product versus Predicate(s)
- a) Section 10.0 – Executive Summary
- b) Section 11.0 – Device Description
- c) Section 12.0 – Substantial Equivalence Discussion
Group V: Adhering to Patient Safety
- a) Section 13.0 – Proposed Labeling
- b) Section 14.0 – Sterilization and Shelf Life
- c) Section 15.0 – Biocompatibility
Group VI: Software and electronics
- a) Section 16.0 – Software
- b) Section 17.0 – Electromagnetic Compatibility and Electrical Safety
Group VII: Performance testing
- a) Section 18.0 Performance Testing – Bench
- b) Section 19.0 Performance Testing – Animal
- c) Section 20.0 Performance Testing – Clinical
Essentially, the aforementioned categories are connected and focused on certain topics. We have clubbed some sections of the 510(k) submission to make the process easier.
For more 510(k) submission support, talk to Pepgra CRO 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 partner. www.pepgra.com | +1-972-502-9262 | sales@pepgra.com
510(k) submission’s mandatory sections thapersuasive speechest you cannot do without
Here is a list of sections that are required for an FDA 510(k) submission.
Group I: Cover sheet forms
- a) Section 1.0 – Medical Device User Fee Cover Sheet (Form FDA 3601)
- b) Section 2.0 – CDRH Premarket Review Submission Cover Sheet
Group II: What will they see?
- a) Section 3.0 – 510(k) Cover Letter
- b) Section 4.0 – Indications for Use Stchiefessays.netatement
- c) Section 5.0 – 510(k) Summary
Group III: Templatized Sections
- a) Section 6.0 – Truthful and Accuracy Statement
- b) Section 7.0 – Class III Summary and Certification
- c) Section 8.0 – Financial Certification or Disclosure Statement
- d) Section 9.0 – Declarations of Conformity and Summary Reports
Group IV: Comparing your product versus Predicate(s)
- a) Section 10.0 – Executive Summary
- b) Section 11.0 – Device Description
- c) Section 12.0 – Substantial Equivalence Discussion
Group V: Adhering to Patient Safety
- a) Section 13.0 – Proposed Labeling
- b) Section 14.0 – Sterilization and Shelf Life
- c) Section 15.0 – Biocompatibility
Group VI: Software and electronics
- a) Section 16.0 – Software
- b) Section 17.0 – Electromagnetic Compatibility and Electrical Safety
Group VII: Performance testing
- a) Section 18.0 Performance Testing – Bench
- b) Section 19.0 Performance Testing – Animal
- c) Section 20.0 Performance Testing – Clinical
Essentially, the aforementioned categories are connected and focused on certain topics. We have clubbed some sections of the 510(k) submission to make the process easier.
For more 510(k) submission support, talk to Pepgra CRO 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 partner.
www.pepgra.com | +1-972-502-9262 | sales@pepgra.com
Tags: MEDEV 2.7/1 revisions
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