Accelerating Product Development June 25, 2015 IMDMC REG 101 Pathways To Market.

Accelerating Product Development

June 25, 2015IMDMC REG 101

Pathways To Market

Pathways To MarketPathways To Market

Classification of Devices

510(k) Requirements

PMA Requirements

Device ClassificationDevice Classification

Class I - low risk, manual toothbrush

Class II – moderate risk, blood pressure monitor

Class III – high risk, heart valve

Classification Tips Classification Tips

Don't think of bucketsThink of ski slopes

◦Light in Class vs HeavyClass I can require clinical dataClass II may not require clinical dataTest to consensus standardsCheck with FDA if not sure

FDA Request for designationFDA Request for designation513(g) process

Costs money

Part of CDRH presubmission process

Follow FDA guidance

Usually takes a couple of months

Class IClass I

Low riskSubject to General ControlsSome may be exemptedCheck regulationsMust register with FDARecall and reporting systemUsually no submission is required

Class IIClass II

Medium RiskSubject to General and Special Controls

◦Performance standards◦Postmarket surveillance◦Patient registries◦Special labeling requirements◦Premarket data requirements◦Guidelines

Some may be exempted510(k) clearance required

Class IIIClass III

Highest risk OR very novelSubject to general and special controlsPre-Market approval requiredFDA inspection requiredClinical data requiredCheck regulations and guidanceTalk to FDA

How to Classify Your ProductHow to Classify Your Product

Define indication for usePick a predicateFDA.gov

◦Classification Database◦Device panel

Revisit IFULook at competitorsConfirm with FDA

ExampleExample

Transcutaneous Electrical Nerve Stimulator (TENS) device

Indications for use: Depression and Pain

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

Device PanelDevice Panel

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051530.htm

Panel ListingPanel Listing73 Anesthesiology Part 868

74 Cardiovascular Part 870

75 Chemistry Part 862

76 Dental Part 872

77 Ear, Nose, and Throat Part 874

78 Gastroenterology and Urology Part 876

79 General and Plastic Surgery Part 878

80 General Hospital Part 880

81 Hematology Part 864

82 Immunology Part 866

83 Microbiology Part 866

84 Neurology Part 882

85 Obstetrical and Gynecological Part 884

86 Ophthalmic Part 886

87 Orthopedic Part 888

88 Pathology Part 864

89 Physical Medicine Part 890

90 Radiology Part 892

91 Toxicology Part 862

Product ClassificationProduct Classification

RegulationRegulation

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H--MEDICAL DEVICESPART 882 -- NEUROLOGICAL DEVICES Subpart F--Neurological Therapeutic Devices Sec. 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a) Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain. (b) Classification. Class II (performance standards).

TENS DeviceTENS Device

Class IICheck guidancehttp://www.fda.gov/downloads/

medicaldevices/deviceregulationandguidance/guidancedocuments/ucm207059.pdf

Guidance applies to specific product codes, not all 6 possible codes

Intended useIntended useWanted: Indications for use of Depression

and PainFound: A transcutaneous electrical nerve

stimulator for pain reliefHow to get a depression claim?

◦Talk to FDA◦Probably run a clinical endpoint◦Is it worth it?

SummarySummary

Multiple classes of devices based on risk, novelty, patient population, intended use, indication for use

First understand market and user requirements

Check FDA resourcesCan pay FDA to tell you (Be careful what

you with for!)

ResourcesResources Product Classification Database

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm 510(k) Database

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm Premarket Approval Database

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm Class I and Class II Devices Exempt from 510(k)

Requirementshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm

Device Guidance Documents http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm

Let’s Try it Together!Let’s Try it Together!

510k Requirements510k Requirements

Some class I and most class IIDemonstrates that the new device is

“substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed

Follow 21CFR807Use FDA presubmission checklist

Substantial EquivalenceSubstantial Equivalence

Has the same intended use as the predicate; and has the same technological characteristics as the predicate; or

Has the same intended use as the predicate; and has different technological characteristics and the information submitted to FDA; ◦ does not raise new questions of safety and effectiveness;

and◦ demonstrates that the device is at least as safe and

effective as the legally marketed device

FDA Pre-submission ChecklistFDA Pre-submission Checklist

Acceptance Checklist for 510(k)sThe Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510(k)s describes the criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive reviewThe guidance includes acceptance checklists for each type of 510(k) submission:Traditional 510(k) ChecklistAbbreviated 510(k) ChecklistSpecial 510(k) Checklist

Types of 510k SubmissionsTypes of 510k Submissions

Abbreviated – No Brainer

Special – Change that doesn’t alter risk

Traditional – All others

Abbreviated 510KAbbreviated 510K

A guidance documents existSpecial controls are establishedRecognized standards existSummary report

◦Information regarding the efforts to conform with the guidance document/special control(s) & outline any deviations

Not a Special 510kNot a Special 510kModifications that have the potential to alter the

fundamental scientific technology of the device, operating principle(s), mechanism of actionbe submitted as

Examples:◦ surgical instrument that uses a sharpened metal blade to

one that cuts with at a laser ◦ in vitro diagnostic (IVD) device that uses immunoassay

technology to one that uses nucleic acid ◦ Incorporation of a sensing mechanism in a device to

allow the device to function "on demand" rather than continuously

Special 510k examplesSpecial 510k examples

Energy typeEnvironmental specificationsPerformance specificationsErgonomics of the patient-user interfaceDimensional specificationsSoftware or firmwarePackaging or expiration datingSterilizationContact FDA if conducting clinicals

FDA Pre-submission ChecklistFDA Pre-submission Checklist

Checklist for CDRH reviewersUse as a guide for your benefitGood war story

Pre-Market Application (PMA)Pre-Market Application (PMA)

Require FDA approvalProbably not in the classification databaseSupports or sustains human life, is of

substantial importance in preventing impairment of human health, or presents a potential, unreasonable risk of illness or injury

Check for Guidance Documents

Types of PMAsTypes of PMAs

Traditional PMA◦It’s traditional

Modular PMA◦Submitted in pre-defined components◦Project specific

Streamlined PMA◦ FDA guidance document or other published methods for

review which have been evaluated◦ FDA review history dealing with like products (2+)◦ Must be available for the Interactive review process

CBER DevicesCBER Devices

Medical devices associated with the blood collection and processing procedures

Medical devices associated with cellular therapies

InVitro Diagnostics involved with blood testing

Device regulations applyCheck CBER device listFollow CBER guidance documents

PMA Data requirementsPMA Data requirements

Non-clinical data◦ microbiology, toxicology, immunology, biocompatibility,

stress, wear, shelf life, and other laboratory or animal tests

Clinical data◦ study protocols, safety and effectiveness data, adverse

reactions and complications, device failures and replacements, patient information, patient complaints, tabulations of data from all individual subjects, results of statistical analyses, and any other information from the clinical investigations

Companion DiagnosticsCompanion Diagnostics

Any InVitro Diagnostic developed to choose patients for therapy with a specific therapeutic

Must be co-developed with the therapeutic

Starts as a lab developed test and then progresses to an IDE and PMA

PMA and NDA or BLA approved on the same day

FDA Pre-submission ChecklistFDA Pre-submission Checklist

Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) Guidance Document

Have a third party reviewTalk with FDA about Advisory Committee

MeetingMultiple FDA meetings

AM ManufacturingAM ManufacturingWhat class is the Powered wheelchair with

built in monitors?

What questions should you ask about the change in the polymer for the HOA product?

How would you report a change in the data transfer system for the wheelchair

CONTACT USCONTACT US

Diana Caldwell, President & CEO◦[email protected]

Gretchen Bowker, Chief Operating Officer◦[email protected]

Contact us at 317.899.9341Websites: www.pearlpathways.com and

www.pearlirb.com