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

Classification of Devices 510(k) Requirements PMA Requirements

Device Classification Class I - low risk, manual toothbrush Class II – moderate risk, blood pressure monitor Class III – high risk, heart valve

Classification Tips Don't think of buckets Think of ski slopes ◦Light in Class vs Heavy Class I can require clinical data Class II may not require clinical data Test to consensus standards Check with FDA if not sure

FDA Request for designation 513(g) process Costs money Part of CDRH presubmission process Follow FDA guidance Usually takes a couple of months

Class I Low risk Subject to General Controls Some may be exempted Check regulations Must register with FDA Recall and reporting system Usually no submission is required

Class II Medium Risk Subject to General and Special Controls ◦Performance standards ◦Postmarket surveillance ◦Patient registries ◦Special labeling requirements ◦Premarket data requirements ◦Guidelines Some may be exempted 510(k) clearance required

Class III Highest risk OR very novel Subject to general and special controls Pre-Market approval required FDA inspection required Clinical data required Check regulations and guidance Talk to FDA

How to Classify Your Product Define indication for use Pick a predicate FDA.gov ◦Classification Database ◦Device panel Revisit IFU Look at competitors Confirm with FDA

Example Transcutaneous Electrical Nerve Stimulator (TENS) device Indications for use: Depression and Pain rh/cfdocs/cfpcd/classification.cfm rh/cfdocs/cfpcd/classification.cfm

Device Panel eRegulationandGuidance/Overview/Classif yYourDevice/ucm htm eRegulationandGuidance/Overview/Classif yYourDevice/ucm htm

Panel Listing 73Anesthesiology Part Cardiovascular Part Chemistry Part Dental Part Ear, Nose, and Throat Part Gastroenterology and Urology Part General and Plastic Surgery Part General Hospital Part Hematology Part Immunology Part Microbiology Part Neurology Part Obstetrical and Gynecological Part Ophthalmic Part Orthopedic Part Pathology Part Physical Medicine Part Radiology Part Toxicology Part 862

Product Classification

Regulation TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICESPART NEUROLOGICAL DEVICES Subpart F--Neurological Therapeutic Devices Sec 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 Device Class II Check guidance vices/deviceregulationandguidance/guidan cedocuments/ucm pdf vices/deviceregulationandguidance/guidan cedocuments/ucm pdf Guidance applies to specific product codes, not all 6 possible codes

Intended use Wanted: Indications for use of Depression and Pain Found: A transcutaneous electrical nerve stimulator for pain relief How to get a depression claim? ◦Talk to FDA ◦Probably run a clinical endpoint ◦Is it worth it?

Summary Multiple classes of devices based on risk, novelty, patient population, intended use, indication for use First understand market and user requirements Check FDA resources Can pay FDA to tell you (Be careful what you with for!)

Resources Product Classification Database m 510(k) Database Premarket Approval Database Class I and Class II Devices Exempt from 510(k) Requirements Device Guidance Documents nceDocuments/default.htm

Let’s Try it Together!

510k Requirements Some class I and most class II Demonstrates that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed Follow 21CFR807 Use FDA presubmission checklist

Substantial 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 Checklist Acceptance Checklist for 510(k)s The 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 reviewGuidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510(k)s The guidance includes acceptance checklists for each type of 510(k) submission: Traditional 510(k) Checklist Abbreviated 510(k) Checklist Special 510(k) Checklist

Types of 510k Submissions Abbreviated – No Brainer Special – Change that doesn’t alter risk Traditional – All others

Abbreviated 510K A guidance documents exist Special controls are established Recognized standards exist Summary report ◦Information regarding the efforts to conform with the guidance document/special control(s) & outline any deviations

Not a Special 510k Modifications 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 examples Energy type Environmental specifications Performance specifications Ergonomics of the patient-user interface Dimensional specifications Software or firmware Packaging or expiration dating Sterilization Contact FDA if conducting clinicals

FDA Pre-submission Checklist Checklist for CDRH reviewers Use as a guide for your benefit Good war story

Pre-Market Application (PMA) Require FDA approval Probably not in the classification database Supports 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 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 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 apply Check CBER device list Follow CBER guidance documents

PMA 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 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 Checklist Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) Guidance Document Have a third party review Talk with FDA about Advisory Committee Meeting Multiple FDA meetings

AM Manufacturing What 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

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