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Premarket Notification [510(k)] Procedures Rod Perez, M.S.E. Consumer Safety Officer Division of Small Manufacturers, International and Consumer Assistance Western Canada 2009. Medical Device Amendments. Signed into law on May 28, 1976 Gave FDA authority to regulate medical devices

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Premarket Notification [510(k)] Procedures

Rod Perez, M.S.E.

Consumer Safety Officer

Division of Small Manufacturers, International and Consumer Assistance

Western Canada 2009

medical device amendments
Medical Device Amendments
  • Signed into law on May 28, 1976
  • Gave FDA authority to regulate medical devices
  • Defined a device [Sec. 201(h) of the Act]
  • Required classification of device types legally on the market at that time
  • Led to classification of approximately 1,700 different generic types of devices and grouped them into 19 medical specialties
  • Required premarket review of devices
what is a medical device
What Is a Medical Device?
  • an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes
pre amendments vs post amendments
Pre-Amendments vs. Post-Amendments
  • The FFD&C Act divided the arena of medical devices depending on when the devices were introduced into commercial distribution:
  • Pre-Amendments Devices (pre-May 28, 1976)
    • Exempted (with conditions) from marketing clearance
  • Post-Amendments Devices (post-May 28, 1976)
    • Requires marketing clearance
  • Classification regulations for individual device types are found in 21 CFR Parts 862-892
  • Regulations describe the device type as it existed prior to May 28, 1976
  • New indications for use or new technologies are assigned new product codes
what is a device type
What Is a Device Type?
  • 21 CFR 860.3(i) – Generic type of device means a grouping of devices that do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness, and for which similar regulatory controls are sufficient to provide reasonable assurance of safety and effectiveness
regulatory class
Regulatory Class
  • Class determines type of premarket submission required by FDA
    • Class I or II 510(k) Exempt
      • Subject to limitations on exemptions covered under 21 CFR xxx.9 (e.g., 862.9 to 892.9) •
    • Class I or II Non-510(k) Exempt
      • 510(k) Required
    • Class III
      • PMA [510(k) for pre-Amendments devices until 515(b) calls for PMA or the device type is reclassified]
class i exemptions
Class I Exemptions
  • Section 510(l) of the FD&C Act
  • All Class I Devices are Exempt except:
    • those intended for a use which is of substantial importance in preventing impairment of human health, or
    • those that present a potential for unreasonable risk of illness of injury
class ii exemptions
Class II Exemptions
  • Section 510(m) of the FD&C Act
  • Class II devices that do not require 510(k)s to provide reasonable assurance of safety and effectiveness
  • 75 device classifications exempt*
  • Final Rule November 3, 1998

* Subject to the Limitations on Exemptions

limitations of exemption from 510 k class i and ii
Limitations of Exemption from 510(k) - Class I and II

Found in “.9” of Classification Chapters

  • Four Limitations:
    • If the device has an intended use that is different from the intended use of a legally marketed device in that generic type
    • If the device operates using a different fundamental scientific technology than that used by a legally marketed device in that generic type
limitations of exemption from 510 k class i and ii11
Limitations of Exemption from 510(k) - Class I and II

Found in “.9” of Classification Chapters

  • Four Limitations:
    • There are specific limitations for in vitro diagnostic devices
    • There are device-specific limitations as specified in a classification regulation
intended use vs indication for use
Intended Use vs.Indication for Use

- No real clear FDA definition

- Intended use usually provides broad, general use of the device and intent of the user

- Indications for use may refer to specific population of the device use (adult vs. pediatric)

- Both intended use and indications for use can be broad (surgical laser used for general surgical procedures)

- Example of indication for use claim would be: for surgical removal of kidney-stones from kidney.

what is a 510 k
What Is a 510(k)?
  • Premarket Notification
  • Section 510(k) of FD&C Act
  • 21 CFR 807 Subpart E
  • Marketing clearance application
  • Allows FDA to determine substantial equivalence (SE) relative to a legally marketed medical device
what is not a 510 k
What Is Not a 510(k)?
  • A form
  • Establishment Registration
  • Device Listing
  • Premarket Approval (PMA)
510 k classification
510(k) & Classification
  • A 510(k) is the classification process for individual post-amendments devices by:
    • Finding the device substantially equivalent (SE), OR
    • Finding the device not substantially equivalent (NSE)
when is a 510 k required
When Is a 510(k) Required?
  • When introducing a device to the U.S. market for the first time
  • When changing the indications for use for a marketed device
  • When making significant modifications to a previously cleared device
510 k exempt devices
510(k) Exempt Devices
  • Unfinished Devices (Components)
  • Class I (739) and Class II (74) devices exempt by statute or regulation
  • Finished devices not sold in U.S. (Export-Only)
  • Devices covered under another 510(k)
    • For Private Label Distribution
  • Pre-amendments devices
  • Custom Devices
  • Veterinary Devices
who must submit a 510 k
Who Must Submit a 510(k)?
  • Manufacturers
  • Specifications Developers
  • Repackagers who modify the device or its labeling
  • Relabelers who modify the labeling (e.g., instructions for use)
  • Anyone who both manufactures and distributes
who is not required to submit a 510 k
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 _________”
  • Repackager who does not alter the product labeling
  • Distributor or U.S. Importer who furthers marketing of the device, but does not alter labeling or device specifications
what is a predicate
What Is a Predicate?
  • 21 CFR Part 807.92(a)(3) - An identification of the legally marketed device to which the submitter claims equivalence. A legally marketed device to which a new device may be compared for a determination regarding substantial equivalence is a device that was legally marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I (the predicate), or a device which has been found to be substantially equivalent through the 510(k) premarket notification process
what is a predicate device
What Is a Predicate Device?

A legally marketed device that does not require Premarket Approval (PMA) Examples include:

A Pre-Amendments device

A device found Substantially Equivalent (SE) by the FDA

A reclassified device

substantial equivalence se
Substantial Equivalence (SE)
  • A device is “substantially equivalent” when compared to a legally marketed or predicate device if it:
    • has the same intended use
    • has the same technological characteristics
    • has different technological characteristics which do not raise new questions of safety and effectiveness
    • can be demonstrated to be as reasonably safe and effective as the predicate device
substantial equivalence
Substantial Equivalence
  • Substantial Equivalence must be established relative to a legally marketed or predicate* device that does not require a PMA
  • Acceptable “predicate types” include:
    • A Pre-amendments device*
    • A device found by FDA to be Substantially Equivalent (SE), or
    • A reclassified device*

*21 CFR 807.92(a)(3)

substantial equivalence24
Substantial Equivalence
  • SE comparison should account for:
  • intended use and indications for use
  • target population
  • anatomical sites
  • where used (hospital, home, ambulance, etc)
  • energy used and/or delivered
  • human factors
  • design
  • performance data (engineering, bench, animal, design verification, human factors, clinical)
substantial equivalence25
Substantial Equivalence
  • standards
  • materials
  • biocompatibility
  • compatibility with the environment and other devices
  • sterility
  • electrical safety
  • mechanical safety
  • chemical safety
  • thermal safety
  • radiation safety
not substantially equivalent nse
Not Substantially Equivalent (NSE)
  • There is no predicate device
  • Device has new intended use
  • Device has different technological characteristics compared to the predicate device and raises new types of safety and effectiveness questions
510 k decisions
510(k) Decisions
  • If found NSE:
    • Device automatically classified as Class III
    • There are other mechanisms that may be explored for U.S. marketing
      • Reclassification, PMA, HDE, De Novo
  • If found SE:
    • Firm may proceed to market
  • Changes in classification are based on FDA's receipt of new information about a device
  • FDA may, on its own, or in response to an outside petition, change a device's classification by regulation
  • A manufacturer who wishes to have a device reclassified to a lower class must convince FDA that the less stringent class requirements will be sufficient to provide reasonable assurance of safety and effectiveness
  • FDA notifies petitioners of determinations made on petitions for reclassification by a reclassification letter. 
  • If a determination is made to reclassify a device, FDA publishes a proposed rule to reclassify in the Federal Register which includes the scientific justification for reclassification
  • A final rule is published in the Federal Register which changes the reclassification
de novo process
De Novo Process
  • FDAMA amended Section 513(f)(2) to provide a new mechanism for classifying new Class III devices for which there is no identifiable predicate device
  • Provides a possible route to market low risk device types
  • It allows the recipient of an NSE (not substantially equivalent) letter to request a risk-based classification determination to be made for the device
  • Does not apply to devices that have been classified by regulation into class III
  • An applicant of a 510(k) who receives an NSE determination can request a De Novo classification of the product into Class I or II
de novo process31
De Novo Process
  • The request must be in writing and sent within 30 days from the receipt of the NSE determination
  • The request should include:
    • device description, labeling, reasons for the recommended classification (into Class I or II), and information to support the recommendation
  • There is a 60-day FDA review period
  • If FDA classifies the device into Class I or II, the applicant will then receive an approval order to market the device
  • If FDA determines that the device will remain in the Class III category, the device cannot be marketed until the applicant has obtained an approved PMA
finished device
Finished Device
  • 820.3(l) [QSR] - Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized
  • Finished device is subject to 510(k) requirements if it is both in final form and for sale to an end user
accessories and components
Accessories and Components
  • Component (820.3(c)) - Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device
  • Accessories - ”extras” (not defined in the regulations)
  • Accessories/components to a device take on the same classification as the "parent" device unless they are separately classified
  • A finished accessory or a finished component sold to an end user is subject to 510(k) requirements
convenience kits
Convenience Kits
  • Two or more separate types of finished devices packaged together for the convenience of the user is considered to be a kit
  • The classification of the kit is based on the highest classification of the devices that are provided in the kit
  • Submissions for convenience kits should identify all devices provided in the kit and document the marketing status of each device
convenience kits35
Convenience Kits
  • If a 510(k) submission is required, a kit certification should be included. If a 510(k) is not required, this information should be maintained in Device Master Record
  • Certain convenience kits that meet the criteria in the Convenience Kit Interim Regulatory Guidance are under enforcement discretion and do not require a 510(k)
combination products
Combination Products
  • A combination product is a product comprised of two or more regulated components (drug/device or biologic/device) that are combined as a single entity or labeled for use with a specified drug, device, or biologic where both are required to achieve the intended use, indication, or effect
  • FDA has developed InterCenter agreements which establish the lead FDA Center for review and oversight of combination products
  • The Office of Combination Products (OCP) assigns review responsibility for combination products
  • OCP is also responsible for designating the component of FDA with primary jurisdiction for the premarket review and regulation of any product requiring a jurisdictional designation
in vitro diagnostic devices
In Vitro Diagnostic Devices
  • In vitro diagnostics are defined as medical devices that analyze human body fluids, such as blood or urine, to provide information for the diagnosis, prevention, or treatment of a disease
  • Devices are subject to the Clinical Laboratory Improvement Amendments (CLIA) of 1988
  • CLIA requirements vary according to the technical complexity in the testing process and risk of harm in reporting erroneous results
  • Three categories of testing based on the complexity of the testing methodology:
    • waived tests
    • tests of moderate complexity, and
    • tests of high complexity
in vitro diagnostic devices38
In Vitro Diagnostic Devices
  • Laboratories performing moderate- or high-complexity testing or both must meet requirements for proficiency testing, patient test management, quality control, quality assurance, and personnel. These specific requirements do not apply to tests in the waived category
  • May use CeSub eSubmitter software to submit single or bundled 510(k) submissions/supplements and CLIA waiver and categorization applications
  • In vitro diagnostic products have special labeling requirements and distribution restrictions under 21CFR 809, In Vitro Diagnostic Products for Human Use
510 k content and format
510(k) Content and Format

Code of Federal Regulations (CFR)

21 CFR 807.87 – Content

21 CFR 807.90 – Format

Device-Specific Guidances

CFR on the Internet at:

Device Advice

510 k content
510(k) Content
  • 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
  • Copy of Medical Device User Fee Cover Sheet
  • CDRH Premarket Review Submission Cover Sheet
510 k content41
510(k) Content
  • Identification of legally marketed device(s) to which substantial equivalence is claimed
  • Compliance with section 514 Special Controls
  • Indications for Use Statement
  • Truthful and Accurate Statement
  • Standards Data Report, FDA Form 3654 (if applicable)
  • If 510(k) has clinical trial - FDA Form 3674
510 k content42
510(k) Content
  • Photographs, engineering drawings
  • Substantially equivalent statement and detailed comparison with predicate device
  • Statement of similarities and/or differences with predicate device
  • Supporting data for device modifications
  • 510(k) Summary or 510(k) Statement per 21 CFR 807.92 & 807.93
510 k content43
510(k) Content
  • Proposed labeling (package inserts, service manuals, instructions for use, advertising and/or promotional materials)
  • Adherence to voluntary standards
  • Financial Certification or Disclosure Statement or both
510 k content44
510(k) Content
  • Performance Data (bench, animal, clinical)
  • Photographs, Engineering Drawings
  • Biocompatibility, Toxicology, Sterilization and Shelf Life data (as applicable)
  • Electromagnetic Compatibility and Electrical Safety data (as applicable)
  • Software/Hardware Information (as applicable)
  • Device-specific requirements per available guidance documents
510 k content45
510(k) Content
  • Class III 510(k)s must include:
    • Certification that search of scientific literature has been conducted, and
    • Summary of available adverse S&E data with all specific citations from the scientific literature
clinical data requirements
Clinical Data Requirements
  • 10-15% of all 510(k)s require some clinical data
  • May be required when intended use or technology or materials differ from the predicate device
  • Must be collected under the Investigational Device Exemptions (IDE) regulations (21 CFR Part 812)
request for additional information
Request for Additional Information
  • For administratively incomplete submissions (Refuse to Accept)
  • When additional regulatory information or performance data is required to demonstrate substantial equivalence
request for additional information48
Request for Additional Information
  • Reviewer request made via telephone or letter
  • Additional information should be sent to the Document Mail Center within 30 days.
  • Submitter may request extension of up to 180 days
fda review procedure
FDA Review Procedure
  • Application Log-in
  • Division Acceptance
  • Assignment to Reviewer/Review Group
  • ODE Review
  • Decision Letter Issued By Reviewing Division
  • SE Decision Made Public Within 30 days
expedited review
Expedited Review
  • Expedited review of devices subject to 510(k) will generally be considered when a device offers a potential for clinically meaningful benefit as compared to the existing alternatives (preventative, diagnostic, or therapeutic) or when the new medical device promises to provide a revolutionary advance (not incremental advantage) over currently available alternative modalities.
expedited review51
Expedited Review
  • Criteria for expedited review:
  • Device is intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition, and
  • Device addresses an unmet medical need as demonstrated by one of the following:
    • breakthrough technology that provides a significant, clinically meaningful advantage over existing approved technology or alternative treatments; or
    • no approved alternative treatment or means of diagnosis exists; or
    • the availability of the device is in the best interest of patients
confidentiality and misbranding of a 510 k
Confidentiality and Misbranding of a 510(k)

21 CFR 807.95 – Confidentiality

The existence of 510(k)s under review (pending) marketing clearance will remain confidential. “SE” 510(k)s are made public within 30 days on CDRH Homepage

21 CFR 807.97 – Misbranding

Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding

fda review times
FDA Review Times
  • FDA Decision: 90 days
  • First AI Letter: 75 days
  • Second or Later AI Letter: 60 days
mdufma changes
MDUFMA Changes
  • User Fees
  • Bundling
  • Third Party Review of 510(k)s
  • Class II Exemptions
  • Single Use Disposable (SUD) Reprocessed Devices
the 510 k paradigm
The 510(k) Paradigm
  • Traditional 510(k)
  • Special 510(k)
  • Abbreviated 510(k)
traditional 510 k
Traditional 510(k)

Full 510(k)

Contains all elements listed in 21 CFR 807.87

Reviewed in 90 calendar days

special 510 k
Special 510(k)

Manufacturer modifies own legally marketed Class I, II, or III device & determines that a 510(k) is required

Device modification is significant

Modification does not alter the fundamental scientific technology

Not a new intended use

special 510 k58
Special 510(k)

Applicant assesses modification in accordance with 21 CFR 820.30 (Design Controls)

Applicant submits 510(k) with a “Declaration of Conformity” to Design Controls

No evaluation of data

Reviewed within 30 days

special 510 k content
Special 510(k) Content
  • Contains all elements listed in 21 CFR 807.87
  • Coversheet – “Special 510(k): Device Modification”
  • Name of Marketed Device and 510(k) number
  • Description of Modified Device and Comparison to Cleared Device
  • Intended Use
  • Proposed Labeling
design controls
Design Controls
  • All manufacturers (including specification developers) of Class II and III devices and select Class I devices (listed below) are required to follow design controls (§820.30) during the development of their device
  • The design control requirements are basic controls needed to ensure that the device being designed will perform as intended when produced for commercial distribution.
design controls61
Design Controls
  • The manufacturer must have procedures in place and must maintain documentation in the design history file to demonstrate compliance with the design control requirements of §820.30 and completion of the activities identified in the design plan
  • The manufacturer (including specification developer) must establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met
  • FDA will evaluate the adequacy of manufacturers' compliance with design control requirements during routine quality systems inspections for all classes of devices subject to design control
abbreviated 510 k
Abbreviated 510(k)

Applicant is submitting a 510(k) for a new Class II device

Device is subject to Special Controls

Guidance Document; or

Recognized Standard

Applicant complies with available device-specific Guidance Document and/or conforms to Standard

abbreviated 510 k63
Abbreviated 510(k)

Manufacturers may submit:

A declaration of conformity to a recognized standard

A statement that the device will conform to a recognized standard when finally marketed

A statement that the product will conform to a non-recognized standard (decided on case-by-case basis)

abbreviated 510 k content
Abbreviated 510(k) Content

Contains all elements listed in 21 CFR 807.87

510(k) submitted with Summary information on compliance with guidance or standard

Reviewed within 90 days

use of standards
Use of Standards
  • Conformance with recognized consensus standards can provide a reasonable assurance of safety and/or effectiveness for many aspects of medical devices
  • Information submitted on conformance with such standards will have a direct bearing on safety and effectiveness determinations made during the review of premarket submissions
  • If any 510(k) contains a declaration of conformity to the recognized consensus standards, this may eliminate the need to review the actual test data for those aspects of the device addressed by the standards
use of standards66
Use of Standards
  • FDA recognizes certain consensus standards. If the device complies to an FDA recognized standard, the applicant may provide a declaration of conformity to the standard and use the Abbreviated 510(k) submission method. Conformance to FDA recognized standards are voluntary and may be used to demonstrate performance or safety of a device.
using standards three alternatives
Using Standards: Three Alternatives
  • FDA-recognized standard with a declaration
  • FDA-recognized standard without a declaration
  • Non-recognized standard
use of fda recognized standard with a declaration
Use of FDA-Recognized Standard With a Declaration
  • FDAMA approach [§ 514(c)]
    • Manufacturer elects to conform to recognized standard; includes declaration in 510(k)
    • Manufacturer must have supporting data at time of 510(k) submission
    • FDA legally bound to accept declaration to meet applicable requirements
review procedures
Review Procedures
  • Described in previous guidance documents
    • Ensure standard is applicable to device
    • Determine extent to which standard addresses SE issues; ensure 510(k) contains information for remaining requirements
    • Consult supervisor and division director if concerned about adequacy of standard
    • Ensure completeness of declaration
    • Indicate reliance on declaration in review document
use of fda recognized standard without a declaration
Use of FDA-Recognized Standard Without a Declaration
  • Pre-FDAMA approach, but strengthened
    • Manufacturer intends to conform to recognized standard and includes statement in 510(k) to this end
    • Manufacturer must have supporting data before marketing
    • FDA normally accepts statement to meet applicable requirements
review procedures71
Review Procedures
  • Same as for 510(k) with declaration except:
    • Format of statement not prescribed
    • Content should be specific and unequivocal
    • Reliance on statement is documented in review document
use of non recognized standard
Use of Non-Recognized Standard
  • Manufacturer may elect to submit a statement for a non-recognized standard
  • Less assurance that standard will be acceptable
review procedures73
Review Procedures
  • If statements have previously been relied upon for this standard, may proceed
    • Follow procedures for use of recognized standard without a declaration
  • If not:
    • Need to assess whether standard adequately addresses SE issues
    • May need to request additional information
device modifications requiring a new 510 k
Device Modifications Requiring a New 510(k)

A new 510(k) must be submitted for a legally marketed device that is about to be significantly changed or modified.

  • 21 CFR 807.81(a)(3)
    • (i) A change or modification in the device that could significantly affect the safety or effectiveness of the device; OR
    • (ii) A major change or modification in the intended use of the device.
device modifications requiring a new 510 k75
Device Modifications Requiring a New 510(k)
  • Changes in Indications for Use and/or Fundamental Scientific Technology
    • Changes in design, materials, chemical composition, energy source, technological characteristics, sterilization, software, performance specifications, or manufacturing process
  • Changes in Product Labeling
  • Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device” (01/10/97)
significant changes in technology engineering and performance
Significant Changes in Technology, Engineering, and Performance
  • Broad span of design activities
  • All changes in technology, engineering, and performance are evaluated and validated according to GMP requirements to determine if a new 510(k) notice must be filed
significant changes in technology engineering and performance77
Significant Changes in Technology, Engineering, and Performance
  • Changing the control mechanism (analog to digital control, pneumatic to electronic control)
  • Changing the operating principle
  • Changing the energy source
  • Changing the sterilization procedure in a manner that affects performance specifications or reduces the sterility assurance level
significant materials changes
Significant Materials Changes
  • A new 510(k) notice may be required for changes in the basic type of material (i.e., metal versus polymer) or the material formulation
  • Criteria for determining whether changes in the type of material or the formulation of the material require a new 510(k) differ for implantable devices and non-implantable devices
significant materials changes79
Significant Materials Changes
  • For non-implantable devices, a new 510(k) generally should be submitted if:
    • the new material is likely to contact body fluids or tissues and
    • new biocompatibility testing of the material is required by ISO 10993-1
  • For implantable devices, a new 510(k) should be submitted if the new material is likely to contact body fluids or tissues
significant materials changes80
Significant Materials Changes
  • In determining whether a new 510(k) must be submitted, manufacturers also should consider whether the change in materials alters the performance specifications for the device
significant labeling changes
Significant Labeling Changes
  • Expanding the indications for use to a new, distinct patient population
  • Changing the device labeling of a single-use device to permit reuse
  • Switching from prescription to over-the-counter (OTC)
  • Deleting a contraindication
modifications that do not require a 510 k
Modifications That Do NotRequire a 510(k)
  • Change in trade name
  • Adding additional sizes within the specifications
  • Downsizing device functionality
  • Deleting Indications for Use
non significant changes in technology engineering and performance
Non-Significant Changesin Technology, Engineering and Performance
  • Changes to the performance specifications, the dimensional specifications, and the software/firmware may not require a new 510(k) if:
    • They do not affect the indications for use
    • They do not require supporting clinical data on S & E for purpose of determining substantial equivalence, and
    • The results of design validation do not raise new issues of safety and effectiveness
non significant materials changes
Non-Significant Materials Changes
  • A new 510(k) notice generally is not required for a change in the raw material supplier, provided that the vendor supplies the material according to the same/similar specification
non significant labeling changes
Non-Significant Labeling Changes
  • Restricting the indications for use to a subset of the original indications
  • Expanding the population with similar diagnosis, prognosis, etc.
  • Changing the warnings or precautions
  • Revising the labeling to clarify the instructions for use
the 513 g process
The 513(g) Process
  • “Within 60 days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under this Act, the Secretary shall provide such person a written statement of the classification (if any) of such device and the requirements of this Act applicable to the device.”
513 g typical inquiries
513(g) Typical Inquiries
  • To determine whether a product is subject to FDA regulations
  • To determine whether a device is exempt from the 510(k) requirements of the Act.
  • To determine whether a 510(k) is needed for a modification to one's device
  • To determine the least burdensome regulatory pathway for a device which introduces a new technology or a new intended use
513 g user fees fy 2010
513(g) User Fees -FY 2010
  • Standard Fee: $2,940.00
  • Small Business Fee $1,470.00
the 513 g review process
The 513(g) Review Process
  • FDA responses to requests for information about the regulatory requirements applicable to a particular device DO NOT constitute FDA clearance or approval for distribution of that particular device in the United States
content of a 513 g request
Content of a 513(g) Request
  • A Cover Letter
  • A complete device description
  • A concise Indication(s) for Use Statement
  • Either proposed labeling or labeling of a marketed similar product/device
third party review program accredited persons ap
Third Party Review Program:Accredited Persons (AP)
  • Authorized by §523 of the FFD&C Act
  • Gives manufacturers the option of using accredited, non-Federal organizations to review 510(k)s for low and moderate risk devices (in place of FDA’s review)
  • Usually more timely and accessible process with quicker marketing clearance decisions
  • Better allocation of FDA’s resources
third party review program accredited persons ap92
Third Party Review Program:Accredited Persons (AP)

APs have technical/standards/regulatory expertise

No FDA 510(k) fee (AP charges fee)

AP reviews 510(k) and then makes recommendation to FDA

FDA issues 510(k) decision within 30 days

statutory limitation 523 a 3
Statutory Limitation§ 523(a)(3)

Accredited Persons may not review:

Class III devices

Class II devices that:

are permanently implantable

are life sustaining/supporting, or

require clinical data in 510(k)s

510(k)s that require CBER/CDER lead or consulting review (e.g., drug/device combination products)

eligible devices
Eligible Devices
  • More than 670 eligible Class I and Class II device types
  • 60% of all 510(k) submissions
  • Eligible device list accessible from:
accredited organizations
Accredited Organizations

Accredited for expansion pilot and non-pilot devices:

  • TUV America, Inc.
  • Underwriters Laboratories, Inc.
  • TUV Rheinland of North America, Inc.
  • Entela, Inc.
  • California Department of Health Services
  • Intertek Testing Services
  • KEMA Quality, BV (Netherlands)
  • Regulatory Technology Services, LLC

Accredited for non-pilot devices only:

  • Center for Measurement Standards, ITRI (Taiwan)
  • British Standards Institution (United Kingdom)
  • Cheiroon, BV (Netherlands)
  • NIOM Scand. Inst. of Dental Materials (Norway)
  • MedTech Review, LLC
accreditation of third parties
Accreditation of Third Parties
  • FDA serves as accreditation body
  • Emphasis is on adequacy of:
    • Personnel and procedures to ensure competent reviews
    • Controls to prevent conflict of interest
when to think twice
When to Think Twice
  • Special 510(k)s
  • Device eligibility uncertain

(e.g., may require clinical data)

  • Complex, precedent-setting submissions
  • AP lacks relevant experience
how to get started
How To Get Started
  • Check eligible device list
  • Contact AP(s) and ask about:
    • Review timeframe
    • Estimated cost
    • Experience
  • Obtain quote
  • Sign contract/submit 510(k)
devices which need a pma
Devices Which Need a PMA
  • New Devices
    • Not Substantially Equivalent
  • Transitional Class III Devices
    • regulated as drugs prior to the Medical Device Amendments (original NDA# maintained)
    • any device approved via the New Drug Application (NDA) process is now governed by the PMA regulations
      • Includes gauze, adhesive tape, tampons, dialysis fluid, denture cushions
cdrh ecopy initiative
CDRH eCopy Initiative
  • Manufacturers submit an exact duplicate of a premarket submission in electronic form
  • Paper copies must still be submitted
  • Electronic copy can replace one of the required paper copies
  • An eCopy may be submitted for any premarket submission: 510(k), PMA, IDE, HDE, 513(g)
cdrh ecopy initiative101
CDRH eCopy Initiative
  • Benefits
    • Document is immediately loaded into our electronic system and available for use by review staff (including navigational tools)
    • Saves CDRH resources (time and $$)
  • Specific format is needed for PDF files
  • Information available at:

radiation emitting products
Radiation-Emitting Products
  • If your medical device also emits electronic product radiation, additional requirements apply under the Electronic Product Radiation Control Provisions of the Food, Drug and Cosmetic Act
  • Electronic product radiation means:
    • any ionizing or non-ionizing electromagnetic or particulate radiation, or
    • any sonic, infrasonic, or ultrasonic wave which is emitted from an electronic product as the result of the operation of an electronic circuit in such product
radiation emitting products103
Radiation-Emitting Products
  • Included are lasers, ultraviolet lamps, microwave ovens, ultrasound therapy devices and medical diagnostic x-ray equipment
  • Requirements may include submission of reports to FDA, compliance with applicable radiation safety performance standards, retention of certain records, and reporting of accidental radiation occurrences or product defects to FDA
helpful websites
Helpful Websites
  • Medical Device User Fee Modernization
  • Industry (Medical Devices)
  • CDRH Learn

  • Importing and Exporting Medical Devices

helpful websites105
Helpful Websites
  • International Information (Devices)

  • CDRH Device Advice

  • CDRH Standards Program

  • Medical Device Databases


FDA’s CDRH webpage:


- e-mail:

- fax: 301-847-8149

- phone: 1-800-638-2041 or 301-796-7100