# Presentation: 495065

## AdvaMed’s 15th Annual Device Submissions WorkshopArlington, VAMay 2005”Heather S. RosecransDirector, 510(k) StaffCenter for Devices and Radiological HealthU.S. Food and Drug Administration hsr@cdrh.fda.gov(301) 594-1190 x143

- "What A Great 510(k) Should Look Like"

## Where To Start?

- Understand The 510(k) Regulatory Process
- Classification
- Meaning of Substantial Equivalence
- 510(k) Paradigm
- 510(k) for Change or Modification

## Where To Start?

- Familiarize Yourself With Related “Processes”
- Pre-IDE Submissions
- 513(g) Requests
- Class II Petitions for Exemption
- Bundling Policy

## Key Points

- Do Your Homework
- Be familiar with the 510(k) regulations
- Check for CDRH Guidance Documents:
- Administrative
- Device Specific
- General Scientific Concerns
- Software
- EMC
- Material Safety
- Submission Checklists
- Consider FDA-recognized consensus standards

## Where Do I Find It?

- The Internet – Device Advice
- Public Searchable Databases
- Guidances
- CFR
- Releasable 510(k)s
- Product Classification
- FDA Recognized Consensus Standards
- CLIA
- Forms
- Checklists

## What Do I Put In My 510(k) Submission

- Medical Device User Fee Cover Sheet
- Required for all 510(k)s
- Types of submissions exempt from fee
- 	(cover sheet still required):
- Third-Party Reviews
- Submissions intended solely for pediatric use
- A submission submitted by a state or Federal government not for commercial sale
- CDRH Premarket Review Submission
- 	Cover Sheet (voluntary)

**Notes:**
User Fee Cvr Sht:  1. Required to process 510k 2. Assigns payment id to track payment
Cover Sheet:Basic Admin Info for all types of premarket submissions
510k Cover Ltr: contains admin and basic submission info:  classification, contact info, indications for use 

## What Do I Put In My 510(k) Submission

- 510(k) Cover Letter
- Identify 510(k) holder
- Type submission
- Associated submissions
- Basis for submission
- Executive Summary
- concise description of the device, including the indications for use and technology;
- device comparison table; and
- concise summary for any performance testing in the submission.

**Notes:**
User Fee Cvr Sht:  1. Required to process 510k 2. Assigns payment id to track payment
Cover Sheet:Basic Admin Info for all types of premarket submissions
510k Cover Ltr: contains admin and basic submission info:  classification, contact info, indications for use 

## What Do I Put In My 510(k) Submission

- Indications for Use Statement
- Your indications for use statement should be exactly the same as the indications for use listed throughout the rest of your 510(k) submission, including the indications for use in the device labeling.
- 510(k) Summary or 510(k) Statement
- Truthful and Accuracy Statement
- This is a statement signed and dated by the submitter  certifying that all information submitted in the 510(k) is truthful and accurate
- Class III Summary and Certification
- If you have a Class III device, for which we have not called for PMAs, it must contain a Class III Summary and Certification

**Notes:**
Indications for use:  state whether prescription or OTC

## What Do I Put In My 510(k) Submission

- Financial Certification or Disclosure Statement
- if you submit information from clinical studies, you must submit a financial certification and/or a disclosure statement for each clinical investigator who participated in your study.
- Device Description
- Performance Specifications
- Device Design Requirements
- Identify all models, as well as all accessories or components, included in the submission

## What Do I Put In My 510(k) Submission

- Substantial Equivalence
- detailed comparison between device and predicate sufficient to demonstrate the substantial equivalence of the devices, as applicable, in terms of:
- Indications for use
- technology
- performance specifications, including any testing
- Labeling
- Sterilization and Shelf Life
- Biocompatibility
- Direct or indirect contact with patients, you should evaluate the biocompatibility of the patient-contacting materials.

## What Do I Put In My 510(k) Submission

- Software
- Electromagnetic Compatibility and Electrical Safety
- Evaluate its electromagnetic compatibility (EMC).
- Performance Testing:
- Bench
- Animal
- Clinical

## Using the 510(k) Paradigm

**Special**
- State What the Predicate Is
- Clearly State What the Change Is
- Clear Risk Analysis
- Make a Clear Case of Substantial Equivalence
- 	**Abbreviated**
- Clearly identify whether the 510(k) relies on:
- FDA guidance or
- Standard(s)
- Clearly indicate where device differs from standard or guidance

## MDUFMA Review Reminders

- Review complete within 3 cycles of review
- Not substantially equivalent decisions
-  AI before any NSE for lack of data
- 30 days to submit additional information
- 180 Days from AI request  – Maximum Extension Granted

**Notes:**
Refuse To Accept (RTA) counts as 1 cycle – same as additional information request

##      Motherhood & Apple Pie

- Organization
- Helps reviewer to read and navigate your submission quicker and more efficiently.
- Organization Tips
- Clear Technical Writing
- Proper Documentation
- Tabs & Pagination
- Labeled Diagrams and pictures/videos/samples
- Proofread Submissions
- Be consistent throughout submission, eliminating the need for additional information requests i.e., indications that are the same throughout the submission.
-                                ***Don’t be hesitate to call CDRH for advice**

## Test Data/Clinical StudiesTips

- Presentation of test data
- Test objective – Why are you doing it?
- Test protocol/methodology (reference standards where appropriate.
- Present data clearly (tables)
- Conclusions
- Presentation of Results from Clinical Studies
- Apply same principles from above
- Human testing e.g., IDE, Informed Consent
- Appropriate use of predicate comparison charts accompanied by narrative
- *Whenever issues are unclear consider talking with branch chief

## OIVD “Tips/Questions”

- Is there a predicate device?
- Is this a new analyte being detected?
- Are there new indications for use?
- Who is the target population?
- Is this a new matrix?
- Is this screening, confirmation, presumptive?
- Qualitative or quantitative measurements
- What is the principle of the test?
- How is it characterized?

## OIVD “Tips”

- How are assay cutoffs determined?
- Are there any interferences?
- Endogenous: Lipids, Bilirubin, immunological
- Exogenous: Anticoagulants
- Any Cross-Reactivity
- Other Viral or bacterial agents
- Good Clinical Study Protocol
- Inclusion & Exclusion Criteria
- Target Population Described
- Methodologies described
- Reference methods and/or predicate devices
- Statistical methods described
- Quality Control methods described

## Web Sites	

**Device Advice**
**www.fda.gov/cdrh/devadvice**
**Medical Device User Fee Cover Sheet (Form FDA 3601) **
**www.fda.gov/oc/mdufma/coversheet.html **
**CDRH Premarket Review Submission Cover Sheet**
**www.fda.gov/opacom/morechoices/fdaforms/FDA-3514.pdf**
**510(k) Cover Letter**
**www.fda.gov/cdrh/devadvice/314312.html**
**Indications for Use Statement**
**www.fda.gov/cdrh/devadvice/314312.html#link_6**
**510(k) Summary or 510(k) Statement**
**www.fda.gov/cdrh/devadvice/314312.html#link_7**
**Truthful and Accuracy Statement**
**www.fda.gov/cdrh/manual/stmnt1.html**

## Web Sites	

**Class III Summary and Certification**
**www.fda.gov/cdrh/devadvice/314312.html#link_8**
**Financial Certification or Disclosure Statement  **
**FORM FDA 3454, Certification: Financial Interests and Arrangements of Clinical Investigators, ****www.fda.gov/opacom/morechoices/fdaforms/FDA-3454.pdf**
**FORM FDA 3455, Disclosure: Financial Interests and Arrangements of Clinical Investigators, ****www.fda.gov/opacom/morechoices/fdaforms/FDA-3455.pdf**
**See also 21 CFR Part 54 and the guidance entitled, “Financial Disclosure by Clinical Investigators,” at ****www.fda.gov/oc/guidance/financialdis.html. **

## Web Sites	

**Substantial Equivalence**
**ww.fda.gov/cdrh/k863.html.  **
**www.fda.gov/cdrh/ode/dd510kse.pdf**** **
**Labeling**
**www.fda.gov/cdrh/devadvice/314312.html#link **
**Sterilization and Shelf Life**
**Guidance:  Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA - ****www.fda.gov/cdrh/ode/guidance/361.html.  **
**Reprocessed single use devices – Guidance:  Guidance for Industry and FDA Staff – Medical Device User Fee and Modernization Act of 2002 Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices - ****www.fda.gov/cdrh/ode/guidance/1216.html**

## Web Sites	

**Biocompatibility**
**Guidance:  Blue Book Memo, G95-1, Use of International Standard ISO-10993,” and “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing**
**	****www.fda.gov/cdrh/g951.html   **
**Software**
**Guidance:  Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices -  ****www.fda.gov/cdrh/ode/guidance/337.pdf**
**Electromagnetic Compatibility and Electrical Safety **
**Patient contact with any electrically powered component**
**follow IEC 60601 1 (1988): Medical electrical equipment - Part 1: General requirements for safety, including Amendment 1 (1991) and Amendment 2 (1995) or an equivalent method. **

## Web Sites	

**Abbreviated 510(k)s**
**www.fda.gov/cdrh/stdsprog.html **
**Guidance:  “The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance,” **
**	****www.fda.gov/cdrh/ode/parad510.html.**
**“****Use of Standards in Substantial Equivalence Determinations,”  **_**www.fda.gov/cdrh/ode/guidance/1131.html**_
**www.fda.gov/cdrh/devadvice/3145.html#link_9.   **
**See Required Elements for a Declaration of Conformity to a Recognized Standard (Screening Checklist for All Premarket Notification (510(k)) Submissions) at **_**www.fda.gov/cdrh/ode/reqrecstand.html**_** **

## Web Sites	

**The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications – Final Guidance**
**www.fda.gov/cdrh/ode/parad510.html**
**Classify Your Device (Device Advice)**
**www.fda.gov/cdrh/devadvice/313.html**
**Searchable Public Databases **
**www.fda.gov/cdrh/databases.html**