# Presentation: 196458

## Center for Devices & Radiological Health Recall Procedures 

- Maureen M. Bernier, MME, PE
- Office of Compliance
- CDRH/FDA

## Recall				21CFR 7.3(g)

**a firm’s removal or correction **
**of a marketed product **
**that the FDA considers to be in violation of the laws it administers **
**and against which the agency would initiate legal action, e.g. seizure.**

## Removal

**Physical removal from point of use for**
**Repair**
**Modification**
**Adjustment**
**Relabeling**
**Destruction**
**Inspection**

## Correction

**Repair**
**Modification**
**Adjustment**
**Relabeling**
**Destruction**
**Inspection**
**Patient Monitoring**
**WITHOUT physical removal from point of use**

## Not a recall:

**Stock Recovery  - Has not left the possession of the manufacturing firm**
**Market Withdrawal - Not a violation (or minor), or correction or removal of an IDE product**
**Non concur -** **No violation, corrections that do not affect safety or efficacy, upgrade**

## Safety Alert

**A medical device Safety Alert is a notification by responsible persons to device users that the use of a device may, in certain circumstances, pose a risk of substantial harm. **
**Notification takes care of the problem**
**Not necessarily a violation**

##     21 CFR 7.3 (m) Recall classification

- Class I is a situation in which there is a reasonable probability that the use of or exposure to, a violative product will cause serious adverse health consequences or death.
- Class II is a situation in which use of or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III is a situation in which use of or exposure to, a violative product is not likely to cause adverse health consequences.

##     21 CFR 7.3 (m) Recall classification

**Class I:  a reasonable probability ........will cause **_**serious**_** adverse health consequences or death.**
**Class II: may cause temporary or medically reversible adverse health consequences ..........or ........ the probability of **_**serious**_** adverse health consequences is **_**remote**_**.**
**Class III :  .... not likely to cause (any) adverse health consequences.**

## CDRH Recall Actions by Fiscal Year 

- Total              495       555         628         608        638         571

## Congress Mandated 21 CFR 806

**Report of Correction or Removal**
**FDA needs to be aware of health risks**
**Timeliness**
**Do not overburden manufacturers**

## 21 CFR 806

**..shall ... report ... correction or removal ..**
**to reduce a risk to health**
**to remedy a violation which may present a risk to health**
**within 10 working days of **_**initiating**_

## Risk to Health			806.2(j)

**A reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death; or**
**That use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote.**

##    21 CFR 806 exemptions

**Actions taken to improve performance or quality that do not reduce risk to health or remedy a violation**
**Market withdrawal**
**Stock Recovery**
**Routine servicing**
**No report of a correction or removal is required under this part, if **_**a report of the correction or removal**_** is required and **_**has been submitted**_** under parts 803, 804, or 1004 ****	****	**21 CFR 806.10f

## 21 CFR 7                21 CFR 806

- Product identity
- Reason, date discovered
- Risk Evaluation
- Quantity manufactured
- Quantity distributed
- Distribution info
- Recall letter or script
- Recall strategy
- Firm official’s contact info

- C&R number
- Recalling firm contact info
- Brand name, intended use
- 510(k), PMA, exempt
- Model #, Lot #
- Manufacturer contact info
- Reason & actions taken
- Injuries, MDR#s
- Quantity
- Mfr dates, expected life
- Consignee info
- Recall letter or script
- Why any info missing

## Your recall information to FDA

**Provide FDA with enough information to make an evaluation of the health risk**
**Include positive and negative mitigating factors**
**Guidance for industry: **
**http://www.fda.gov/ora/compliance_ref/recalls**_[/](http://www.fda.gov/ora/compliance_ref/recalls/)_
**ggp_recall.htm**

## Your Risk Assessment

**Number of devices involved**
**Complete description of problem**
**Effect on patients**
**Risk assessment – input from: **
**Physician experienced in product evaluation**
**Technical product specialist**
**Medical personnel familiar with device and the patient population**
**Root cause analysis**

## Your recall communication     21 CFR 7.49

**“****Urgent Medical Device Recall” or **
**	****	****“... ****Correction”****	****	****	**7.49b
**Be brief and to the point**
**Clearly identify the product**
**Concisely explain reason for recall and hazard**
**Specific instructions on what to do**
**Provide a means for recipient to report to your firm****	****	****	****	**7.49c(1)

## Depth of recall

**If you recall a laboratory product, does the physician who ordered the test need to know?**** **
**If you recall to the distributor level and instruct them to recall further - give them a model letter**

## FDA 

**Classify the Problem **
**Risk to Health**
**Evaluate the Communication**
**Effectively communicate risk**
**Wording of Letter**
**Distribution of Letter**
**Audit recipients**
**Evaluate the Quality System**
**Corrective and Preventive Action**
**Validation**

## What you need to do

**Evaluate the health risk**
**Notify **
**Disposition – correct or remove**
**Fix the problem**
**Validate the fix **

## Desired Outcome

**Remove the risk to health**
**Prevent recurrence**

## Do the Right Thing