# Presentation: 670825

## OIVD Workshop

- Premarket Notification (510(k))
- April 22, 2003
- Parklawn Building
- Rockville, MD
- Presented by
- Marjorie Shulman
- Premarket Notification Staff
- Office of Device Evaluation
- Center for Devices and Radiological Health
- (301) 594-1190 x 144

## What is a 510(k)?

- Premarket Notification
- Section 510(k) of F,D, & C Act
- 21 CFR 807 Subpart E
- Marketing Clearance Application
- Allows FDA to Determine Substantial Equivalence (SE)

## What a 510(k) Is Not

-   A form
-   Establishment Registration (FDA-2891)
-   Device Listing  (FDA-2892)
-   Premarket Approval  (PMA)
-   Product Development Protocol (PDP)

## A Device is Substantially Equivalent (SE) if:

- In Comparison to a legally marketed        device, it:
- Has the same intended use, and
- Has the same technological characteristics as the predicate device, or:

## SE (cont.)

- Has the same intended use, and
- Has different technological characteristics and the information in the 510(k):
- Does not raise new questions of safety and effectiveness, and
- Demonstrates it is as safe and effective as the predicate

## May 28, 1976

- PREAMENDMENT DEVICE:				Exempted (with Conditions)			from Marketing Clearance
- POSTAMENDMENT DEVICE:			Requires Marketing Clearance

## Establish Equivalence to:

- A legally marketed device that does not require a PMA, i.e., a:
- 		Preamendments device, or
- 		A device found by FDA to be 			Substantially Equivalent (SE), or
- 		A reclassified device

## FDA finds the device Substantially Equivalent?

- NO:								PMA Application						or							PDP Application						or
- DeNovo Application
- YES:								To Market

## 510(k) Submission Required When:

- Introducing a device to the market for the first time
- Change in intended use for a marketed device
- Making significant modification to a marketed device

## Modifications - 

- Changes in Intended Use
- Modifications that significantly enhance (or decrease) Safety or Effectiveness, e.g.		-change in design, materials, chemical 		  composition, energy source, or 			  manufacturing process
- Guidance:  “Deciding When to Submit a 510(k) for Change to an Existing Device”		(1/10/97)

## Who Must Submit a 510(k)

- Manufacturers
- Specifications Developers
- Repackagers who change device or its labeling
- Relabelers who change the labeling, e.g., instructions for use

## Who is Not Required to Submit a 510(k)

- Private Label Distributor who _only_ adds company name and wording such as:
- “Distributed by ___________” or
- “Manufactured for _________”

## Not Required to Submit (cont.)

- Repackager who does not alter labeling
- Distributor or Importer who furthers marketing of the device and does not alter labeling or change device

## Devices Exempt from 510(k)

- Unfinished Device
- Class I and II devices exempt by statute or regulation
- Finished device not sold in U.S.
- Device covered under another 510(k), i.e,	private labeled device
- Preamendment device
- Custom Device

## 510(k) Content and Format

- 21 CFR 807.87 and 807.90
- Device Advice
- Device Specific Guidance
- 510(k) Refuse to Accept Checklist

## 510(k) Format

- Cover Letter or Cover Sheet
- User Fee Payment ID Number
- Table of Contents
- 510(k) Checklist
- Correct Pagination
- Required Information
- 1.5” left margin, unbound

## Information Requested in 510(k)(21 CFR 807.87)

- Submitter’s name, address, phone/fax #, contact person, rep./consultant name, establishment registration number
- Device Classification Name, CFR number, device class, procode
- Common/usual name and trade/proprietary name and model numbers

## Information Requested (cont.)(21 CFR 807.87)

- Identification of marketed device(s) to which equivalence is claimed
- Compliance with section 514 Special Controls
- Proposed labels, labeling, and advertising

## Information Requested (cont.)(21 CFR 807.87)

- Photographs, engineering drawings
- Substantially equivalent statement and comparison with predicate
- Statement of similarities and/or differences with predicate device
- Data for changes for modified devices

## Information Requested (cont.)(21 CFR 807.87)

- 	510(k) MUST include either:
-   5_10(k) Statement__	__510(k) Summary_
-    Applicant gives		FDA provides 510(k) info to 		or	the summary to requesters			requesters via
-    within 30 days			FOI process &						Internet
- *Content and Format (21 CFR 807.92 & 807.93)

## Information Requested (cont.)(21 CFR 807.87)

- Class III 510(k) must include:
- 		Certification and literature search has 		been conducted, and
- 		Summary of adverse S&E data with 		citation to the literature
- *Content and Format (21 CFR 807.94)

## Information Requested (cont.)(21 CFR 807.87)

- Indications for Use Statement
- Truthful and Accurate Statement
- Proposed labeling
- Adherence to voluntary standard
- Financial Certification or Disclosure Statement or both

## Information Requested (cont.)(21 CFR 807.87)

- Performance Data (bench, animal, clinical)
- Sterilization, Software and Hardware Information, if any
- Address information requested in specific guidance documents

## Clinical Data in 510(k)

- 10-15% of all 510(k)s
- Important difference with the predicate device
- Must be collected under IDE
- 	(21 CFR Part 812)

## FDA Requests Additional Information for:

- Incomplete submissions (Refuse to Accept)
- When testing data is required to demonstrate equivalence

## Additional Data (cont.)

- Reviewer request by phone or letter
- Forward to Document Mail Center
- 30 days to submit
- May request extension of time

## FDA Review Procedure

- Application Log-in
- Division Acceptance
- Assignment to Reviewer/Review Group
- ODE Review
- FDA Issues Decision letter
- SE Decision Made Public Within 30 days

## 510(k) Paradigm

- Special 510(k)
- Abbreviated 510(k)

## Special 510(k):  Device Modification

- Manufacturer modifies own legally marketed device & determines that a 510(k) is required
- Modification does not affect intended use or fundamental scientific technology

## Special 510(k):  Device Modification

- Manufacturer assesses modification in accordance with 21 CFR 820.30
- 510(k) is submitted with “declaration of conformity” to design controls and summary of design control activities
- Description of modified device and comparison to cleared device
- Previous intended use and new intended use
- FDA processes in less than 30 days

## Summary of Design Control Activities

- Risk analysis method(s) used to assess impact of the modification of the device
- Results of risk analysis
- Verification and/or validation activities required (including methods and acceptance criteria)
- Declaration of conformity with design controls

## Declaration of Conformity to Design Controls

- Statement that all verification and/or validation activities were preformed and results demonstrate that the acceptance criteria were met
- Statement that manufacturing facility is in conformance with DC procedure requirements
- Statements must be signed by designated individual(s)

## Abbreviated 510(k)

- Manufacturer intends to market new “reserved” Class I, Class II or Class III device
- Device is subject to special controls/FDA guidance or standard(s)
- Manufacturer uses special controls/FDA guidance or conforms to standard(s)

## Abbreviated 510(k)

- Required elements of 21 CFR 807.87
- 510(k) submitted with summary information on special controls and/or “declaration of conformity” with standard(s)

## Confidentiality of Information

- 21 CFR 807.95

## Misbranding by Reference to 510(k)

- 21 CFR 807.97

## Suggestions

- Submit two copies
- Clearly label what type of 510(k)
- Paginate accurately
- Include Table of Contents
- Include 510(k) Screening Checklist citing page numbers

## 510(k) StatisticsFY’s 00, 01 and 02

- 510(k)s Received:
- FY 00 - 4,204
- FY 01 - 4,254
- FY 02 - 4,320
- 510(k)s Logged Out:
- FY 00 - 4,397
- FY 01 - 4,148
- FY 02 - 4,376

## 510(k) StatisticsFY’s 00, 01 and 02

- Average Review Times
- FY 00 - FDA Days 77	Total Days 104
- FY 01 - FDA Days 74	Total Days 106
- FY 02 - FDA Days 79	Total Days 100
- Cycles
- FY 00 - 1.42
- FY 01 - 1.38
- FY 02 - 1.39

## Appeal Process

- Normally under 21 CFR 10.75
- For any decision						- hold letter						- not equivalent						- policy matter
- May request a meeting
- Will receive written response

## Appeal Process (cont.)

- Guidance Available						-Medical Device Appeals and Complaints
- - Resolving Scientific Disputes Concerning the Regulation of Medical Devices
- Status

## 510(k) Rescission Regulation

- Currently Under Development
- Current Reasons						-Significant Public Health Risk(s)		-Fraud							-Other Compelling Reasons

## MDUFMA

- Medical Device User Fee and Modernization Act of 2002
- www.fda.gov/cdrh/mdufma
- Contact DSMICA:  (800)638-2041 or (301)443-6597
- Send an email to:  MDUFMA@cdrh.fda.gov

## MDUFMA (cont)

- First year fee = $2,187 per 510(k)
- Reduced fee to protect small businesses.  Small = sales and receipts less than $30 million
- Small business fee for 510(k) starts FY 04
- Sunset October 1, 2007
- No fee for Third Party 510(k)

## 510(k) Guidance Websites

- The New 510(k) Paradigm
- - www.fda.gov/cdrh/ode/parad510.html
- Frequently Asked Questions and Answers on Paradigm
- - www.fda.gov/cdrh/ode/qanda510k
- Determination of Intended Use for 510(k) Devices
- -www.fda.gov/cdrh/ode/k98-1.html

## 510(k) Guidance Websites

- General/Specific Intended Use
- - www.fda.gov/cdrh/modact/genspec.html
- Class I Exemption Regulation
- - www.fda.gov/OHRMS/Dockets/98fr/011400a.pdf
- Class II Exemption Regulation
- -www.fda.gov/cdrh/modact/frclass2.html

## 510(k) Guidance Websites

- Convenience Kit Interim Regulatory Guidance
- - www.fda.gov/cdrh/ode/convkit.html
- Evaluation of Automatic Class III Designation
- - www.fda.gov/cdrh/modact/classiii.html
- Procedures for Class II Device Exemptions from 510(k)
- - www.fda.gov/cdrh/modact/exemii.html

## 510(k) Guidance Websites

- Deciding when to Submit a 510(k) for a Change to an Existing Device
- -www.fda.gov/cdrh/ode/510kmod.html
- Preamendment Status Determination
- www.fda.gov/cdrh/preamend.html
- Blue Book Memo:  Fax & E-mail Comm.
-      -  www.fda.gov/cdrh/ode/A02-01.html

## 510(k) Guidance Websites

- Device Advice
- - www.fda.gov/cdrh/devadvice
- Good Guidance Practices
- - www.fda.gov/cdrh/ggpmain.html
- Medical Device Appeals and Compliants
- - www.fda.gov/cdrh/modact/dispres1.pdf
- Resolving Scientific Disputes Concering the Regulation of Medical Devices
- -www.fda.gov/cdrh/resolvingdisputes/1121.html

## 510(k) Guidance Websites

- Expedited Review
- 	- www.fda.gov/cdrh/modact/expedite.html
- Redacted Version of 510(k)s
- 	- www.fda.gov/OHRMS/DOCKETS/98fr/
- 		122199a.txt
- Reuse of Single Use Devices
- 	- www.fda.gov/cdrh/reuse/index.shtml

## FDA Guidance Documents

- Facts-on-Demand:						1-800-899-0381 (Index is #919)			301-827-0111
- Division of Small Manufacturers, International and Consumer Assistance (DSMICA) 1-800-638-2041 or 301-443-6597
- Internet:  http://www.fda.gov/cdrh