Form Fda 2277 PDF Details

Form FDA 2277 is a form that medical device manufacturers use to report adverse events related to their devices. This form is mandatory for medical device manufacturers, and must be submitted to the Food and Drug Administration (FDA) within 15 days of discovering an event. Reporting adverse events is important in order to help identify potential safety issues with devices, and can help protect patients from potential harm. In this blog post, we'll provide a brief overview of Form FDA 2277, and discuss what needs to be included in a submission. We'll also provide some tips for completing the form correctly.

QuestionAnswer
Form NameForm Fda 2277
Form Length2 pages
Fillable?No
Fillable fields0
Avg. time to fill out30 sec
Other namesclearance form, ISSO, employee clearance form, yyyy

Form Preview Example

U.S. Department of Health and Human Services

EMPLOYEE EXIT CLEARANCE RECORD

Food and Drug Administration

(Instructions on Reverse)

 

 

Notice to Existing Employee:

Employees separating from Federal service require a Certification for Separating Employees – FDA Form 2097. The form is found at: http://www.fda.gov/opacom/morechoices/fdaforms/default.html and is turned in at the Ethics point of exit below.

The HHS Exit Survey helps the Department attract and maintain a high-quality workforce. It is voluntary, anonymous and found at: http:// career.psc.gov/exit_survey.taf. Employees separating from HHS should consider completing the survey.

1.NAME (Last, First MI)

2.LAST 4 DIGITS OF SOCIAL SECURITY NUMBER

3.ORGANIZATION

4.PROJECTED EXIT DATE (mm/dd/yyyy)

5.SEPARATION DATE (mm/dd/yyyy)

6.ACTUAL EXIT DATE (mm/dd/yyyy)

7.REASON FOR LEAVING (Select one)

Resignation

Termination

Retirement

Transfer to another Federal agency (Inside HHS)

Transfer to another Federal agency (Outside HHS)

Death

Note: Exit points do not need to be visited in order.

Cleared

 

Not

 

N/A

 

Official Signature

Date

Cleared

 

 

(mm/dd/yyyy)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8.

FINANCIAL SERVICES*

(301) 443-0446

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12345 Parklawn Drive, 2nd Floor)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

9.

PASSPORT/VISA*

(301) 827-4480

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(PKLN 15A-55)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10.

LIBRARY SERVICES*

(301) 796-2039

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(any branch – see instructions for locations)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11.

ROCKVILLE HR CENTER

(301) 827-4140

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(PKLN 9C-15)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

12.

ETHICS

(301) 827-5511

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(PKLN 6B-17)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

13.

PSC PARKING PERMIT & TRANSHARE*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(PKLN 5B-07)

(301) 827-2414

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14.

PSC CHILD CARE*

(301) 443-2516

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(PKLN 17A-29)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

15.

RECORDS

(301) 827-1476

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a. Center/ORA Document Room*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

b. Supervisor (see instructions)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

16.

SYSTEM APPLICATIONS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Center/OC/ORA ISSO – see instructions)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

17.

OFFICE ADMINISTRATIVE OFFICER

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a. Accountable Property

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

b. IT/Telecom & other Office Equipment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

c. Travel Card

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

d. PCard

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

e. Access Key/Pass

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

18.

PERSONNEL SECURITY

(301) 827-5521

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a. (PKLN 15A-22) Clearance Check/Debriefing*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

b. (PKLN 15A-22) FDA Credentials*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(301) 827-5521

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

c. (PKLN 12A-43 or WO22 1344) FDA Badge

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(301) 827-5913

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

19.

EMPLOYEE SIGNATURE

 

 

DATE (mm/dd/yyyy)

20. SUPERVISOR SIGNATURE

DATE (mm/dd/yyyy)

 

 

 

 

*Administrative Officers may contact the exit point to determine the status then check

21. ADMINISTRATIVE OFFICER'S SIGNATURE

DATE (mm/dd/yyyy)

and sign on behalf of the exit point. For a list of contact information, see this Form listing

 

 

 

 

at the FDA Forms site: http://intranet.fda.gov/omp/forms/oc_list.htm.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Submit completed form to the Employee Resource and Information Center, Mailcode HFA-705

FORM FDA 2277 (3/08) PREVIOUS EDITION IS OBSOLETE

PSC Graphics: (301) 443-1090 EF

INSTRUCTIONS FOR COMPLETING FORM FDA 2277

This form, Employee Exit Clearance Record, is to be completed for all employees leaving the Food and Drug Administration. For the exit points marked with an asterisk, the employee’s Administrative Officer may contact the exit point by phone or email to determine the status then check and sign and date on behalf of the exit point. For all other exit points, the exiting employee should hand-carry Form FDA 2277 Employee Exit Clearance Record to the location listed on the front of the form. The exit point representative will determine if the exit requirements are met, check the appropriate box then sign and date in the space provided. The exit points do not need to be visited in the order they appear. When all of the exit points are checked, the employee, Administrative Officer, and Supervisor sign and date the form. Submit completed forms to the Employee Resource & Information Center, 12345 Parklawn, Mailcode HFA-705.

Item Explanation

1-3 Self-explanatory.

4The projected exit date is last date that the employee expects to be physically in the office.

5The separation date is the last day that the employee is paid by the agency.

6The actual exit date is the last day that the employee is physically in the office.

7Self-explanatory.

For items 8 through 21, the explanation indicates the requirement of each exit point.

8The employee must satisfy any outstanding salary or travel advances.

9The employee must return any government issued passports or visas.

10The employee must return any outstanding library materials. Locations are: White Oak building 2 room 3051, PKLN 11B40, CDRH CORP room 030, CFSAN CPK1 room 1C-100, and NCTR Bldg 10 room 115.

11The employee receives information regarding the continuation or termination of benefits upon separation from FDA.

12An employee leaving Federal service completes and submits FDA Form 2097 to the Ethics and Integrity Staff in PKLN 6B-17.

13The employee must return any parking permits and passes, and PSC official schedules the termination of any Transit Subsidy benefits.

14PSC official schedules the termination of any Child Care Subsidy benefits.

15a The employee must return any records that were borrowed from the Center/ORA Document Room.

15b The employee must turn over official agency records maintained by the employee to the supervisor, including the records maintained in a home office or on the employee’s person computing devices such as a Blackberry, hard drive, CD-ROM, or on other media.

16The Information System Security Officer schedules the termination of the employee’s network and application accounts such as but not limited to email, EASE, and AIMS. The ISSOs are listed at the following website: http://intranet.fda.gov/ocio/SITP/ITsecurity/issos.htm

Item

Explanation

17a

The employee must return any accountable property to

 

the Administrative Contact. This includes FDA

 

personal computers borrowed for at home use.

17b

The employee returns any government issued

 

telecommunication or IT equipment such as a

 

Blackberry device, mobile phone, or remote access

 

token. The Administrative Officer must notify the ISSO

 

of the status of remote access tokens.

17c

Travel cardholders must destroy their government

 

issued travel credit card and coordinate the closure of

 

the credit card account with the office Administrative

 

Contact and the Center Travel Card coordinator.

17d

Purchase Card (PCard) holders should destroy the

 

PCard and coordinate the closure the credit card

 

account with the office Administrative Contact and the

 

FDA PCard Coordinator.

17e

The employee must return any specialized access

 

keys or passes. (This does not refer to the employee’s

 

FDA Badge.)

18a

The personnel security staff conducts a clearance

 

debriefing in person for employees with a secret and/

 

or top secret clearance.

18b

Credentials are associated with secret and top secret

 

security clearances. The employee must return their

 

FDA credentials.

18c

The employee must return their FDA identification

 

badge. White Oak employees may turn badges in to

Shaniece Gathers (WO22 1344) or Kim Bibbs (WO22 1340).

19The employee’s signature certifies that the employee has met all the exit responsibilities.

20The Administrative Officer's signature signifies that either the employee or the Administrative Officer has obtained all the necessary signatures from all the clearance points.

21The supervisor reviews the Exit Clearance Record and identifies and ensures the resolution of any potential security lapses or financial liabilities.

FORM FDA 2277 (3/08) PREVIOUS EDITION IS OBSOLETE

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