# Presentation: 282636

## Slide 1

## Everything You Ever Wanted to Know About Medical Device Marketing Clearance

-  **Robert Phillips, Ph.D.**
**Chief, Radiological Devices Branch**
***Office of Device Evaluation***
***Center for Devices and Radiological Health***
***FDA***
***RAP@cdrh.fda.gov***

**Notes:**
Good morning. My name is Bob Phillips
Thank Dr. Meyers and Ms Travis
Simple title/ more complicated explanation

When asked the same question now I say “device regulation” people look quizzical including my friends and family, the answer is more complex
In fact, after 22 years at FDA I’m still learning and there are times when the answer still seems somewhat elusive.

## Outline

-  **Sources of Information**
** ****Statutory Basis**
** ****Routes to Market (Clearance        ****	****Processes)**
** ****Investigational Use**
** ****Submission Fees**

## Contacts

- Web site: WWW.FDA.GOV/CDRH
- Division of Small Manufacturers Assistance: 1-800-638-2041
- Program Operations Staff; IDE, 510(k), PMA: (301) 594-1190
- Radiology Branch: (301) 594-1212
- For *Post-market reporting:          *MedWatch: 1-800-FDA-1088

**Notes:**
And finally, again I would like to thank the University for inviting me, and while I hope that I’ve given you somewhat of a clue as to what we do and how we think, if you have questions or comments I’d be happy to listen to them.
For additional information on specific device related issues, guidances, newly approved devices etc., I would refer you to the following excellent sources... and for those of you who like talking to people rather than computers, give me a call and if I don’t know the answer, likely, I’ll find someone who does.

## Slide 5

## Useful Pages

- Device Advice
- Guidance Documents
- Voluntary Standards
- Obtain Market Clearance / Approval

## Slide 7

## Useful Pages

- Device Advice
- Guidance Documents
- Voluntary Standards
- Obtain Market Clearance / Approval

## Slide 9

## Useful Pages

- Device Advice
- Guidance Documents
- Voluntary Standards
- Obtain Market Clearance / Approval

## Slide 11

## Useful Pages

- Device Advice
- Guidance Documents
- Voluntary Standards
- Obtain Market Clearance / Approval

## Slide 13

## Medical Device Amendments

- May 28, 1976

## Role of FDA

**Establish **_***reasonable***_** assurance of the safety and effectiveness of medical devices marketed **
**in the U.S.**

**Notes:**
As you can see the word reasonable is highlighted. Congress recognized, and I think we would all agree that the desire for absolute knowledge must be balanced by a recognition 
of what is feasible and practical. We would all like to know up front everything about a new device, drug, or vaccine, but we’d also like it to benefit ourselves and our children not our great great grandchildren.

## Statutory Basis:Federal Food, Drug, and Cosmetic Act 

_**As amended by**_**:**
**Medical Device Amendments-1976**
***Devices Classified***
**Safe Medical Device Act (SMDA)-1990**
***Expanded role***
***More detail***
**FDA Modernization Act-1997**
***Redefined (more circumscribed) role***
***More interactive with sponsors***
***Expanded/earlier access of new technologies to patients***

## Statutory Basis:Federal Food, Drug, and Cosmetic Act (2)

**Medical Device User Fee and   Modernization Act (MDUFMA) of 2002**
***User fees***
***Review time goals***

## Medical DeviceAn instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:1) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man, or 2) intended to affect the structure or any function of the body of man, andwhich does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent upon being metabolized for the achievement of its primary intended purposes.Section 201, Food Drug and Cosmetic Act 

**Notes:**
Medical devices are defined quite broadly as anything that impacts human health which does not achieve its purpose through chemical action and is not metabolized.
More and more, however, the distinction between device, drug, and biologic is becoming less clear and so-called combination products may be regulated concurrently by 2 or more centers.
Some examples are drug delivery systems and cellular products encased in various inert materials.

## Medical Device Approval Process

- Most devices on market prior to May 28, 1976 were “grandfathered”
- Marketing clearance for these devices through 510(k) clearance process-- Substantially Equivalent
- 510(k)d devices are _not_ approved
- Most radiological products on market using this process

## Routes to Market

- Premarket Submission
*501(k)*
- Premarket Approval Application
*PMA*

## Grandfathered Devices

- Pre 1976 devices placed into three classes
- Class I- General controls
- Class II- Special controls
- Class III- PMA

## Class I

- Low risk devices
- Safety and effectiveness assured by
- Good Manufacturing Practices
- Post-marketing surveillance
- Registration and listing

## Class II

- Class I controls plus
- “Special controls”
- Voluntary standards
- Mandatory standards
- Guidance
- Manufacturing inspection

## Class III

- Premarket approval application that establishes Safety and Effectiveness

## 510(k)

- Substantially Equivalent – *New device is compared to a similar device that is on the market.*
- Device need be only as good (or bad) as what was on market in 1976
- 510(k) clearance _does not_ assure effectiveness
- Many devices are exempt from 510(k) submission
- Review time about 90 days

## Medical Device Approval Process

- Devices that sustain life, implants, in class III, or can not be shown substantially equivalent are approved by PMA process
- In a PMA the sponsor must demonstrate that the device is safe and effective for intended use

## PMA’d Devices

- Less than 2% of submissions approved via PMA  (similar to NDA)
- Magnetic Resonance
- Bone Sonometry
- Diagnostic ultrasound as an aid in determining breast malignancy
- CAD devices

## PMA Content

-  Indications for use
-  Device description
-  Laboratory testing
-  Preclinical studies
-  Clinical studies
-  Labeling
-  Manufacturing (GMP)

## PMA Process

-  Multi discipline review
-  May be reviewed by FDA advisory panel
-  FDA review time = 180 days
- Data is proprietary

## Routes to Market

- Premarket Submission
*501(k)*
-  **“****Me Too” process**
- Premarket Approval Application
*PMA*
***Determination of Safety and    Effectiveness***

## Investigational Use

- Safety and effectiveness studies on devices that are not market cleared
- Needs IRB approval
- Needs informed consent
- FDA involvement depends on “significant risk” vs. “non-significant risk”
- If significant risk = FDA IDE approval needed.
- If not significant risk = Only IRB approval needed

## Investigational Use

- Investigational studies can be multi-phase
- Studies should be well presented
- Intended indications for use
- Literature review
- Scientific basis
- Safety issues well understood
- Protocol scientifically sound
- Reasonable study endpoints

## Pre-investigational Contacts

- FDA/CDRH will meet with you.
- Meetings early in the development/testing stage are desirable
- Meetings are not depended on “significant risk” status
- We work on a “least burdensome” basis

## Summary

- Extensive sources of information are available
- There are multiple pathways to market clearance
- FDA decisions are driven by risk and effectiveness issues
- Contact the appropriate FDA/CDRH component early in the process

## FY2004 Submission Fees

|  | Fee Rates |  |
| --- | --- | --- |
| PMA | Full | Sm. Bus. |
|   Full Fees | $206,811 | $78,588 |
|   180-Day Supps | $  44,464 | $16,896 |
|   Real-Time Supps. | $  14,890 | $5,658 |
| 510(k)’s | $    3,480 | $2,784 |

## Fee Exemptions and Waivers

- First time PMA application from a small business – waiver
- Any device intended to be used solely for pediatric use – exempt from fees
- State or Federal government applications – exempt from fees (ex for comm. dist.)
- Small Business = Ann gross revenue ≤ $30M

## What the “Critical Path” Is

- A serious attempt to bring attention & focus to the need for more scientific effort and publicly-available information on *evaluative tools*
- Evaluative tools:  The techniques & methodologies needed to evaluate the safety, efficacy & quality of medical devices as they move down the path

## Contact

**Web Address:**
_**http://www.fda.gov/oc/initiatives/criticalpath/**_
**Open Docket:**
_**http://www.fda.gov/dockets/ecomments**_
**Docket # 2004N-0181**
**CDRH webpage (under news and events) provides links to the critical path white paper and docket:**
_**http://www.fda.gov/cdrh/**_