# Presentation: 525043

## Device Case Processing

**Andrea Latish**
**Case Expert**
**CDRH Office of Compliance**
** ****Division B**

## Tools Used in Support of Regulatory Actions

- Food, Drug and Cosmetic Act
- Code of Federal Regulations (CFR)
- Compliance Policy Guides (CPG)
- Regulatory Procedures Manual (RPM)

## Violative Devices

- Adulterated
- 	(Section 501 FD & C Act)
- Misbranded
- 	(Section 502 FD & C Act)

## Commonly Used Device Charges

- _Adulteration Sections:_
- 501(f)(1)(B) – Failure to PMA
- 501(c) – Lack of labeled quality
- 501(h) – Not following GMP’s (21 CFR 820)
- 501(i) – Not following IDE regulations
- (21 CFR 812)

## Commonly Used Device Charges (Continued)

- _Misbranding Sections:_
- In Vitro Labeling 21CFR 809.10
- 502(a) – Label false or misleading
- 502(b) – Missing device name, firm name, 	and address
- 502(f)(1) – Inadequate directions for use
- 502(f)(2) – Lack of adequate warnings

## Commonly Used Device Charges (Continued)

- _Misbranding Sections:_
- 502(o) – No Premarket Notification [510(k)] No Registration and Listing
- 502(j) – Danger to Health
- 502(t)(2) – Failure to report MDR’s / 	Corrections or Removals
- 		(21CFR 803 and 806)

## Types of Regulatory Actions

- Administrative
- 	FDA Acts on its own to exercise authority
- Judicial
- 	FDA acts in coordination with legal system

## Types of Enforcement Actions

- _Administrative Actions_
- Warning Letter
- Civil Penalty
- Administrative Detention
- Section 518 Actions [FDA Recalls]
- Import Alert
- Automatic Detention

## Administrative Actions

_**WARNING LETTER**_
- Written communication to firm or individual(s) that FDA considers their products, practices, processes or other activities to be in violation of the Act and that failure to take appropriate and prompt action to correct the violations may result in regulatory action being initiated without further warning. ESTABLISHS PRIOR WARNING; ALLOWS FOR VOLUNTARY COMPLIANCE.

## Administrative Actions (Continued)

_**CIVIL PENALTY (Devices only)**_
- Action which can go to a hearing conducted by an administrative law judge for most violations of the Act; penalty may not exceed $15,000 for each violation and may not exceed $1,000,000 for all violations in a single proceeding.

## Administrative Actions (Continued)

_**ADMINISTRATIVE DETENTION**_
- The temporary (30 days maximum) detention of devices believed to be adulterated or misbranded, until the agency has had time to consider what action it should take concerning the devices, and to initiate legal action, if appropriate.

## Administrative Actions (Continued)

_**SECTION 518 ACTIONS**_
- Section 518(a) – Notification
- Section 518(b) – Repair, Replacement, or 			Refund
- Section 518(e) – Recall Authority

## Types of Enforcement Action

_**REGULATORY ACTIONS**_
- Seizure
- Injunction
- Citation/Prosecution/Grand jury investigation

## Most Common Regulatory Actions

_**Seizure**_
- Action against a device (section 304)
- Product(s) – may be lot/model specific
- May include raw materials, labeling, packaging, finished devices

## Most Common Regulatory Actions (Continued)

_**INJUNCTIONS (Section 302)**_
- An order issued by the court requiring a defendant to do or refrain from doing a specified act
- Action against firm and/or individuals who control the manufacture/movement of devices

## Most Common Regulatory Actions (Continued)

_**CITATION (Section 305 Meeting (Opportunity)**_
- Hearing, Pursuant to section 305 of the Act, held prior to consideration of criminal, proceedings _under title 21_ that gives the parties (possible defendants) an opportunity to present their views

## Most Common Regulatory Actions (Continued)

_**PROSECUTION**_
- Criminal action directed against firm and/or responsible individuals

## Most Common Regulatory Actions (Continued)

_**Different types of Prosecutions**_
**Misdemeanor **– Sentence of imprisonment is not more than one year; sentence of fine is not more than $5,000; or both
**Felony **– Sentence of imprisonment is not more than five year; sentence of fine is not more than $10,000; or both

## Most Common Regulatory Actions (Continued)

- Prosecution (continued)
- Title 18
- False statements to the Government
- Felony
- 5 years prison/$10k or both/count

## Case Flow

- Inspection
- District Office
- Compliance Officer
- CDRH (OC)
- Office of Chief Counsel (OCC)
- Legal
- Dept. of Justice
-       (DOJ)
-   (injunctions)

- Asst. U.S. Attorney
- (Seizures)

- Administrative

- Administrative
- Law Judge (ALJ)
- (CMP)

- Specific Direct
- Reference Authority

- Except in most significant/unusual circumstances, FDA provides firm’s/individuals an opportunity to voluntarily correct violations!