# Presentation: 793779

## CDRH Executive Briefing

- David W. Feigal, Jr., M.D., M.P.H.
- Director
- Center for Devices and Radiological Health
*Washington, DC October 4, 1999*

## Overview

- FDAMA
- Regulations
- Reengineering
- Cross-cutting Activities
- Resources
- Alternatives in 510(k)s, MDRs
- Harmonization

## FDAMA AccomplishmentsYear Two

- Stakeholders meeting, live video teleconference
- Report to Congress, “Designing a Medical Device Surveillance Network” Draft guidance
- Updated lists
- Devices for third party review
- Recognized consensus standards

**Notes:**
This list illustrates the center’s implementation of FDAMA during Year 2.
We were very anxious to avoid the kinds of delays in implementation that occurred following the Safe Medical Device Amendments of 1990.
We succeeded in doing that (and I have to remind you that there were no additional funds appropriated for FDAMA) and I think most of you are probably very familiar with these achievements.
In the first year, we put out many guidance documents and final rules (more than many of you could digest).
We recognized more than 400 consensus standards.
We exempted more than 60 class II devices from premarket requirements.
We put the third party review program into place on time, designated 13 third parties to do 510(k) reviews, and made more than 150 types of devices eligible for such review.  And that’s only part of what we accomplished.
In year 2, we held a stakeholders meeting and a live teleconference to let our constituencies know how FDAMA was impacting them.
We reported to Congress our progress on designing a surveillance network.
We updated lists of devices eligible for 3rd party review, and increased the number of recognized standards for use in premarket notification.

## FDAMA AccomplishmentsYear Two

- Draft guidance
- Resolving scientific disputes
- Least burdensome means to market
- Updated guidance
- FAQ on consensus standaards
- Amended panel procedures
- Device tracking

**Notes:**
We also drafted guidance on resolving scientific disputes and on what constitutes the least burdensome means to market.  We also updated other guidance.
These were all necessary achievements and they reflect an enormous investment of center time and resources.  

## Regulations Published in ‘99	

- 62 regulations published in CY ‘99 so far
- 7 final rules
- 3 Direct to Final Rules
- 11 Proposed Rules
- 38 Notices
- 3 Advanced Notice of Public Rule Making (ANPR)

**Notes:**
Final rules  include:
Quality mammography standards
Requirement for PMAs for saline-filled breast implants
Class II devices exempted from 510(k)s
Proposed rules include:
Reclassification of surgeon’s and patient examination gloves
Reclassification of 38 pre-Amendments class II devices into class II
Notices include:
Guidance on resolving scientific disputes concerning device regulation
 Medical device warning letter pilot
Guidance on QSIT (Quality Systems Inspections Technique)
Public meeting on public availability of information on investigational clinical trials for serious or life-threatening illnesses
Draft guidance on evidence models for least burdensome means to market
Guidance on device tracking under FDAMA

## Reengineering

- Examples of Reengineered Process
- New 510(k) paradigm
- Regulations development
- Recalls
- GMP inspections
- Products development protocol (PDP)
- Modular PMA review
- Standards

**Notes:**
One of the most important aspects of FDAMA for us is that it codified a lot of what we were already doing in our reengineering efforts:
As most of you remember, things were not going well in the early 90’s.  For a variety of reasons, we developed huge backlogs. Industry and Congress were both very critical of us.  And morale was low.
We dug ourselves out of these difficulties with the help of some workload management changes and, in 1994, some new  resources of about $13 million, which went mostly to premarket review.
For the last five years, we basically have had a flat budget but we’ve been getting a lot more work -- and implementation of FDAMA is just one reason.
With more work and a flat budget, we needed to reexamine how we did our work and how to refocus resources from lower to higher risk products and activities. A couple years ago, we embarked on some business-style reengineering.  
In the premarket notification area, we used a risk-based approach to target our resources.  So we exempted most class I’s and some II’s from 510(k)s, and revamped the process to allow speedier handling of some changes and of applications where manufacturers declare conformance to standards -- the so-called new 510(k) paradigm. 
We improved project management for our regulations development activities, resulting in a better quality product that takes less time to complete.
We delegated authority for lower-risk recalls to the districts, which had been making the recommendations anyway.
We made a number of changes to GMP inspections.  The field now notifies companies before routine inspections, which has resulted in more organized and efficient inspections.  Companies can also make corrections on the spot to some deficiencies we find during the course of the inspection.  This results in faster resolution of problems.
And we revitalized an authority we already had but had not used, the product development protocol, where we and the manufacturer agree on the needed data and the product can go to market when the up-front agreement is fulfilled.
We now have a process for accepting PMAs as a compilation of modules that together become a complete application.  The process utilizes early meetings with industry to identify data needs and resolve issues.  So far, we’ve received about 75 PMA shells.  Four have been completed and 3 of them were done in under 180 days from start to finish.  
We have also recognized over 400 national and international standards, and have developed a standards database that can be accessed by all Center staff.

## Reengineering	

- New Projects
- Postmarket process
- Registration and listing
- QSIT and HACCP
- Class I recalls
- Radiological health
- Bioresearch monitoring

**Notes:**
Our reengineering efforts are continuing in several new  areas.  This list shows the new teams that are currently operating.  The three I wanted to touch on here are postmarket process, registration and listing, and QSIT and HACCP.

The postmarket process refers to what occurs to the product after it’s on the market.  We need to do a better job integrating our postmarket experience data, including adverse event data, with our premarket program, and we need to feed information back to manufacturers and users to improve the product and the ability of purchasers and patients to use it safely and effectively.

We’ve held a number of meetings with industry and other stakeholders all across the country to discuss the possibility of manufacturers using the Internet to register and list electronically.  This would streamline the process and reduce the burden on manufacturers and at the same time provide FDA with a more reliable database.

QSIT is an acronym for Quality System Inspection Technique and HACCP is Hazard Analysis and Critical Control Points. These are processes we’re developing to change the nature of inspections to a quality systems approach.  Our goals are to achieve shorter inspections that uncover the more important problems and result in more productive interactions with companies.

## Cross-cutting Issues

- Staff from many offices work together
- Immediate problem - Ad hoc committee
- Evaluates, follows issue from several perspectives
- Safety Alert, Public Health Advisory
- Forum for industry, medical community, consumers & gov’t to work on solution together
- Standing committee on one type of device
- Follows, coordinates activities across Center
- Works on solutions to specific problems as above

**Notes:**
Many of the issues we work on cut across Office lines -- it’s not just a compliance or postmarket  or premarket evaluation problem, but one which can be resolved only with the combined expertise of several offices.
Some problems are immediate and relatively short-term and we address those with an Ad Hoc committee.  An example is the case of potential cross-contamination in hemodialysis treatment.  Several incidents had been reported.  While our Office of Compliance worked to determine the cause, an Ad Hoc committee developed a Safety Alert to send to dialysis centers so they would check for this problem.
Other products  or issues require long-term  efforts and we have standing committees for those.  Examples are breast implants and electromagnetic interference.

## CDRH FTE History

**76**

**77**

**78**

**79**

**80**

**81**

**82**

**83**

**84**

**85**

**86**

**87**

**88**

**89**

**90**

**91**

**92**

**93**

**94**

**95**

**96**

**97**

**98***

**99***

**0**

**250**

**500**

**750**

**1000**

**Medical Devices**

**Radiological Health**

**Mammography Act**

**Med. Dev. Amend.**

**Merger of BRH & BMD**

**MQSA**

**Fiscal Year**

**Pre-SMDA FTE Level (952)**

**SMDA**

**FDAMA**

**CDRH FTE History**
**Fiscal Years 1976 - 1999***

## CDRH FTE Distribution

**Premarket**

**497**

**Postmarket**

**181**

**Compliance**

**154**

**International**

**34**

**Science**

**136**

**MQSA**

**57**

**RCHSA**

**50**

**Premarket**

**552**

**Postmarket**

**139**

**Compliance**

**93**

**International**

**27**

**Science**

**91**

**MQSA**

**71**

**RCHSA**

**64**

**CDRH FTE Distribution**

**FY95**
**N=1,109**

**FY98**
**N=1,037**

## Resources Are Shrinking

- Flat line budgets have meant actual decrease in funds available for program.
- CDRH down 113 FTEs since FY 1996;          includes 45 positions cut in last fiscal year.
- FDAMA added new responsibilities without funding.
- International activities are costly.

## Resources Are Shrinking

- Workload complexity is increasing.
- Review timeframes are still too long(e.g., PMAs – 12.4 months total elapsed time).
- Administration’s FY 2000 budget does not request additional premarket resources.
- Congressional budget includes targeted increases and an unfunded pay-raise

## Shrinking Resources: Re-engineering

- Mechanisms:
- 510(k) Changes
- Modular PMA
- 3rd party review
- MDR Summary reporting

## 510(k)s - Alternatives	

|  | Applications
Received
(4-98 to 9-99) | 
Review Complete | Average Review Time |
| --- | --- | --- | --- |
| Abbreviated | 105 | 82 | 91 |
| Special | 458 | 411 | 28 |
| Traditional	
 | 6147 | 6453	 | 110 |

**Notes:**
All the numbers are from the same timeframe, 3-20-98 (the start of the Paradigm) until 9-17-99.

Special 510(k)s:  
Received:  458
Logged Out:  411
SE:  370
NSE: 1           Other (e.g., deleted, withdrawn, etc.):  40
Average FDA review days:  23
Average Total review days:  28
The remaining 47 are under review or on hold awaiting additional information.

Abbreviated 510(k)s:
Received:  105
Logged Out:  82
SE:  70
NSE: 1            Other:  11
Average FDA review days:  77
Average Total review days:  91
The other 23 are on hold or under review

Traditional 510(k)s:
Received:  6147
Logged Out:  6453
SE:  4995
NSE:  108        Other:  1350
Average FDA Review Days:  87
Average Total Review Days:  110

[I can't give you the difference of the ones on hold or under review because unlike the specials and abbreviated 510(k)s some of the 6453 logged out were received before 3-20-98].

The main reasons for conversion from a Special 510(k) to a Traditional 510(k)s are:

  New indication for use.
  The declaration of conformity was in the future tense.
  Change in fundamental scientific technology.
  The applicant submitted the special for an exempt device.

## 510(k)s - Third party review	

- 154 device types eligible
- mostly class II
- same device types = 1200    510(k)s / yr
- only 32   510(k)s submitted to 3rd parties so   far this fiscal year
- Average total review time for comparable 510(k)s -- same product code & fiscal year:                               		3rd party -                 57 days                                           		All FDA review -    105 days

**Notes:**
154 device types are eligible for 3rd party review
For these device types, we generally receive about 1200  510(k)s each year.  So potentially, we could receive 1200 3rd party review 510(k)s each year.
This fiscal year, only  32 510(k)s were submitted to third party reviewers
Still, this is more than any previous year.  
Total third party 510(k)s logged out this year:  29                                             (all “substantially equivalent)
For these 29 510(k)s:
Average total time from third party’s receipt to FDA’s decision was 57 days
In contrast, the average total time from FDA’s receipt to FDA’s decision for comparable 510(k)s was 105 days.  (same product code, same fiscal year)
Percent cleared by FDA on first review cycle was 90% (26 of 29 devices)

## Summary Reporting of MDRs	

- Goal:  Reduce “noise” in the MDR system, improve the signal to noise ratio
- Allow periodic submission of well-known, repetitive reports in line item format
- Expect 38,000 summary reports in FY ‘99
- 45 manufacturers participating
- 52 exemptions
- New system in place for January 2000

## Manufacturer Reports(Includes Summary Reporting)

**Notes:**
Summary reporting is a great success story.
We have decreased individual reporting dramatically at a considerable savings to ourselves and we believe a savings of time and effort to industry -- while not compromising patients’ safety.
We allow summary reporting of specified adverse events that are well-known and anticipated.  FDA permits the manufacturer to submit these reports on a periodic basis as a summary rather than individual reports.  Our analysts carefully evaluate these summary statistics for trends.
The same manufacturer is required to submit individual reports if the adverse events are not specified for summary reporting.

## Global Harmonization

**Global Harmonization**

- _Http://www.fda.gov/cdrh/harmmain.html_

- 7th meeting on June 27-July 1, 1999  Hosted by the U.S.

**Notes:**
The Center for devices has put considerable effort global harmonization.
Since 1992, the Global Harmonization Task force has been involved in developing guidance documents addressing various aspects of device regulation, including 
premarket evaluation, 
postmarket vigilance (otherwise known as adverse event reporting),
 quality systems and design controls, 
and auditing and inspections.
We expect harmonization to benefit both industry and government:
Greater uniformity and standardization in the way devices are regulated by various countries.
Facilitate international trade
Expand global markets
Broaden access to medical technologies
enable national regulatory agencies to easily share information about premarket evaluations, inspectional results and injuries and deaths associated with particular devices.
At its seventh meeting held here this summer, the Global Harmonization Task Force for the first time formally endorsed a dozen guidance documents.  This sets the stage for the five principal member governments to consider formal adoption and implementation of these guidelines as part of their own regulatory programs.  
These programs could ultimately serve as models for regulatory programs of developing nations, and curtail the problems the result from differing regulatory systems.

## CDRH: The Future

- Transparent
- Adequately Resourced
- Re-engineered
- FDAMA-ed
- Science Based
- Partners
- Credibility
- “Yours and Ours”

## Our Website:

- www.fda.gov/cdrh