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 x144

[Powerpoint]

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:
  
  

  510(k) Statement		510(k) Summary
  Applicant gives 510(k) info to requesters within 30 days	or	FDA provides the summary to requesters via 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.pdf
• 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/comp/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/dispresl.pdf
• Resolving Scientific Disputes Concerning 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.html

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