Investigational Device Exemptions IDE CFR Title 21, Part 812

1. Investigational Device Exemptions (IDE)CFR Title 21, Part 812 Kim Hall, RN Clinical Research Coordinator Cardiology

2. Investigational Device Exemptions (IDE)CFR Title 21, Part 812 What are investigational devices ? All clinical investigations of devices to determine safety and effectiveness ? Can include new devices (PMA) or devices on the market applying for a new indication ? FDA approves the application from Sponsor or manufacturer and gives the device a category depending on the risk and previous or similar device on the market (i.e.: stents, ICD, pacemaker, new software, etc.) ? DEVICE: any healthcare product other than drug or biologic that is intended for human use. Includes: -implanted devices: Anything placed surgically -software downloads that come in contact with patient : i.e. pacemakers or defibrillators - surgical lasers, wheelchair, sutures, vascular grafts, intraocular lenses, orthopedic pins, diagnostic aids such as test kits for invitro diagnosis of disease and other medical conditions such as pregnancy � �

3. Investigational Device Exemptions (IDE)CFR Title 21, Part 812 PMA- premarket approval- http://www.fda.gov/CDRH/DEVADVICE/pma/ Title 21 Code of Federal Regulations (CFR) Part 814, ? FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. ? Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Significant risk ?most stringent type of device marketing application required by FDA ?must receive FDA approval of its PMA application prior to marketing the device ? PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s) ? it is a private license granting the applicant (or owner) permission to market the device

4. Investigational Device Exemptions (IDE)CFR Title 21, Part 812 Humanitarian Device Exemption (HDE) � ? premarket approval application submitted under 21 CFR 814 seeking a humanitarian device exemption from the effectiveness requirements of sections 514 and 515 of the FD&C Act as authorized by section 520( Humanitarian Use Device (HUD) � ? is approved for marketing thru the HDE application ? a medical device under 21 CFR 814 intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. ? based upon valid scientific evidence in a significant target population, the use of the device for its intended uses and conditions of use, when accompanied by specific directions for use and warnings against unsafe use, will provide clinically significant results. ? can only be used after IRB approval ? labeling must state �Humanitarian Use Device� �

5. Investigational Device Exemptions (IDE)CFR Title 21, Part 812 IDE (Investigational Device Exemption) ? approved or considered approved Investigational Device Exemption under 21 CFR 812 and section 520(g) of the FD&C Act ? permits a device that would normally be required to comply with a performance standard or have a PMA. ? Labeling under 21 CFR 812.5 must state: ? name, place of business, of the manufacturer/ packer/ distributor ? the quantity of contents, if appropriate ? the statement � CAUTION: Investigational Device. Limited by Federal or United States) law to investigational use�

6. Investigational Device Exemptions (IDE)CFR Title 21, Part 812 Sponsor/Manufacturer applies to FDA for PMA (Pre-Market Approval) or IDE (Investigational Device Exemption IDE Application must contain: ? name and address of sponsor ? complete report of prior investigations of device ? accurate summary of the investigational plan ? complete investigational plan ? description of methods, facilities, and controls used for manufacture, processing, packing, storage , installation of device ? example of agreements that will be entered into by investigators to be compliant ? list of names and addresses of investigators who will participate and signed agreement ? list of names , address, and chairperson of each IRB asked to review ? names and addresses of any institution participating ? if device is to be sold or reimbursed, what the charge is and why the sale is not commercialization ? copies of labeling for device ? copies of patient informational materials and forms provided to patients to obtain consent Investigational Plan must contain: ? Purpose ? Protocol ? Risk analysis ? Description of device ? Monitoring Procedures ? Copies of labeling ? Consent material ? IRB information ? Institutions involved

7. Investigational Device Exemptions (IDE)CFR Title 21, Part 812 FDA Grants Approval Category A ( Experimental): the initial questions of safety and effectiveness have not been resolved and the device and associated services are not considered eligible for Medicare reimbursement Category B 1-4(Investigational; Non-Experimental): ? Class III devices �require pre-market approval, ? there is incremental risk regarding safety and effectiveness, ? or the FDA has previously approved a similar device, ? MAY be eligible for Medicare coverage and payment

8. Investigational Device Exemptions (IDE)CFR Title 21, Part 812 Management and Use of IDE (Sponsor has already done site selection visit to assess facility and ability to manage study) PRIOR T0 START OF STUDY: Contract negotiated and signed, potentially include device supplied at no charge if not: will insurance be billed? What about for patients whose insurance will not pay, or no insurance: ?device provided . Injury clause must match contract SUBMIT for IRB Approval: IRB Initial submit form, WIRB cover letter, FDA approval letter, (with IDE number G-) consent form (injury clause must match the contract language), protocol, Investigational use device instructions( Investigator Manual), pt informational materials, forms (CRF, QOL, etc. ), advertisement/web site listing, IRB Approval Sponsor initiation training of all study personnel prior to start of study -FDA requires DOCUMENTED Training of all study personnel Delegation log- PI can assign duties to study personnel Consenting, device dispensing of device, device accountability, assess AE, etc. Letter to CMS for approval � Part A to Roanoke (centralized ), -Part B to Contracted group Timonium,MD done after IRB approval- see attached examples of what to include in submission Equipment entered into environment needs to be inspected and safety tested by Biomed Department

9. Investigational Device Exemptions (IDE)CFR Title 21, Part 812 IDE Strict Maintenance Ship directly to Coordinator or designated person in your area too ensure security of devices Store in locked , secure location away from general supply or stock ( if do not have a cabinet ask if one can be provided ) Device Accountability Log- Verify and Maintain record of receipt, return ( why), expiration dates, lot and serial numbers of devices, who received and dispensed device- Dispense device as close to procedure /use as possible What device in what patient Strict adherence to device use as trained per protocol � DO NOT DEVIATE Record any issues with device and report or sponsor/FDA as appropriate per reporting procedures Record any adverse events related to patient as result of device, report per reporting procedures of protocol

10. Investigational Device Exemptions (IDE)CFR Title 21, Part 812 � CONSENT ING Process After consenting patient , call insurance company to see if the policy jacket supports investigational devices. Is the entire procedure denied or just what is considered investigational under the individual policy. May need to talk with Medical Director- if possible May need to send letter for predetermination with explanation why this device is appropriate and support reasoning why the patient might benefit ( examples of letters) This process may be appealed and submitted to policy decision making team of insurance company- may or may not be approved and they will send letter of decision