# Presentation: 574153

## Approach	

- Administrative Elements of a 510(k)
- Analytical Elements of a 510(k)
- Clinical Elements of a 510(k)

## Suggestions that can lead to  quality 510(k) submissions 

- Prepared by: Carol Benson, MA
- and Alberto Gutierrez, PhD

## Submission Suggestions DO NOT

- Send in submissions when:
- there are known deficiencies
- studies have not been completed
- software has not been validated

## Submission Suggestions (DO)

- Send all documents through the DMC
- Include your email address if acceptable for FDA to contact by email
- When responding by email, include an electronic copy of your draft labeling
- Follow guidance documents (FDA device specific or other such as NCCLS)

## Administrative Elements

- CDRH submission cover sheet (A-I)
- Include a table of contents
- Indications for use form
- Truthful and Accurate statement – signed
- Financial Disclosure form 807.87(i)
- 510(k) statement **OR** summary

## Administrative

- Include page numbers; number all pages
- Description of your device
- Comparison to predicate device
- Clearly separate your device’s labeling from the predicate device’s labeling

## Administrative

- Protocols used to establish performance
- Data and information that was collected
- Analyses
- Reference any guidance documents used

## 510(k) statement OR 510(k) summary

- For content and format follow:
- 21 CFR 807.92 (510(k) summary) Submitter's name, address, contact person, date are frequently missing
- 21 CFR 807.93 (510(k) statement)

## Indications for Use form

**Indications for Use ****	****	****	****	****	****	****	****	****	**
- 510(k) Number (if known):_                                _
- Device Name:_                                             _
- Indications For Use:
- Prescription Use _______	    AND/OR	         Over-The-Counter Use _______
- (Part 21 CFR 801 Subpart D)					(21 CFR 807 Subpart C)
- 	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
- _          ____________________________________________________________________       _	_       _
- 	Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
- 														Page 1 of _____

## Indications for use (IFU)

- Provide on a separate page
- Include the trade name(s) of the device
- IFU Specific to your device
- Not necessarily word for word from the CFR

## Indications for use form

- Number pages if using more than one page
- If intended for home use, state for home use
- If intended for a specific population or testing location, state - such as newborns, screening, monitoring, workplace, etc.
- Check for OTC or prescription use

## Description of your device

- Describe all components of your device
- State if calibrators and controls are to be sold separately
- Use the same trade name throughout the submission

## Special 510(k)s

- Clearly describe all changes to the device in one location of the submission
- Including changes to software, design of the device, antibody type, changes in composition of reagents and any labeling changes
- Include the labeling for the modified device

## Special 510(k)s

- Identify the risk analysis FTA or FMEA
- Identify the verification/validation activities
- Include your acceptance criteria
- Declaration of conformity (DC) for verification and validation activities
- DC for manufacturing facility for conformance with design control procedure requirements (820.30)

## Abbreviated 510(k)s

- Clearly identify the submission as abbreviated
- State the guidance/recognized standard that was used
- State any deviations from the guidance/standard
- Provide all elements of regular 510(k): IFU, 510(k) summary/state, T&A, etc.

## Device Labeling

- Follow 21 CFR 809.10
- Studies in the labeling should match the studies performed for clearance
- Include a statement summarizing the data upon which each specific performance characteristic is based

## Device Labeling	

- State the cut-offs in the intended use (toxicology)
- DOA - Include the warning paragraph about screening test providing a preliminary result – see FDA DOA guidance

## References

- Use the CDRH web site (device advice) that walks you through the 510(k) process
- Use the OIVD web site & quick links to search the 510(k) data base to look up 510(k) summaries and FDA review summaries
- Use OIVD web page & quick links for guidance documents or CDRH web page (software)

## Reference Web Sites

- http://www.fda.gov/cdrh/
- http://www.fda.gov/cdrh/oivd/index.html
- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm