# Presentation: 533161

## Center for Devices & Radiological Health Recall Procedures 

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

## Congress Mandated 21 CFR 806

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

##     Reports:  21 CFR 7 vs 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

## 21 CFR 806 timeframe

**10 working days from **_**initiation**_
**CDRH usually receives the date of the issuance of the letter, or the date phone calls are started, or the date the field engineers receive their orders to repair.**
**Technically, if FDA collects an internal document where the CEO approved the recall plan, **_**that**_** is the initiation date.**_ _

## 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**

## CDRH Recall Procedure

**Determine if Firm’s Correction or Removal Action Meets Definition of a Recall **
**Violation**
**Adulterated**
**Misbranded**
**Violation or health risk significant enough for FDA action**
**Distributed, out of firm’s control**

## Stock Recovery

- Has not left the possession of the manufacturing firm

## Market Withdrawal

- Not a violation (or minor)
- Violation: Adulterated or Misbranded

## Non concur

**No Violation**
**Corrections that do not affect safety or efficacy**
**Upgrade**

## Depth of recall (strategy)

- Different degree of oversight needed if the device is in CVS pharmacies than if it is at the Big Lots or Dollar store
- Recall to the distributor level and instruct them to recall further - give them a model letter

## Your recall communication

**21 CFR 7.49**
**If you put the notice on the bottom of the invoice, is the clerk in the billing department going to run down to the OR and take the device off the shelf?**

## Your recall information to FDA

**Please provide us with enough information to make an evaluation of the health risk**
**Include positive and negative mitigating factors**
**Do you want our Medical Officer to make an erroneous assumption?**
**District request for monthly reports is our way of checking the effectiveness of the recall**

## Classify the Recall

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

##     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.**

## Recalls by Fiscal Year

## Recall Actions by Fiscal Year

**	****	****	****  ****2001****	****    2002****	****2003****	****   2004**
**Class 1****	****     7****	****      15****	****	****   7****	****      23**
**Class 2****	**** 395****	****    467****	****	****460****	****    473**
**Class 3****	**** 153****	****    146****	****	****141****	****    142**
**Safety Alert****	****     4****	****        6****	****	****    9****	****      13**
**	**
**Total****	****	**** 559****	****    634****	****	****617****	****    651**

## 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. **
**Not necessarily a violation**

## Desired Outcome

**Remove the risk to health**
**Classification is not “where the rubber meets the road”**

##     C&R exemption by MDR Report

**21 CFR 806.10 (f)**
**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**

## Do the Right Thing