|
|
| [Code of Federal Regulations] |
| [Title 21, Volume 8] |
| [CITE: 21CFR822] |
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
| |
| PART 822 | POSTMARKET SURVEILLANCE |
|
|
|
|
Subpart G - Records and Reports
|
|
Sec. 822.31 What records am I required to keep?
|
|
You must keep copies of:
(a) All correspondence with your investigators or FDA, including required reports;
(b) Signed agreements from each of your investigators, if your surveillance plan uses investigators, stating the commitment to conduct the surveillance in accordance with the approved plan, any applicable FDA regulations, and any conditions of approval for your plan, such as reporting requirements;
(c) Your approved postmarket surveillance plan, with documentation of the date and reason for any deviation from the plan;
(d) All data collected and analyses conducted in support of your postmarket surveillance plan; and
(e) Any other records that we require to be maintained by regulation or by order, such as copies of signed consent documents, evidence of Institutional Review Board review and approval, etc.
|
|
|
Sec. 822.32 What records are the investigators in my surveillance plan required to keep?
|
|
Your investigator must keep copies of:
(a) All correspondence between investigators, FDA, the manufacturer, and the designated person, including required reports.
(b) The approved postmarket surveillance plan, with documentation of the date and reason for any deviation from the plan.
(c) All data collected and analyses conducted at that site for postmarket surveillance.
(d) Any other records that we require to be maintained by regulation or by order.
|
|
|
Sec. 822.33 How long must we keep the records?
|
|
You, the designated person, and your investigators must keep all records for a period of 2 years after we have accepted your final report, unless we specify otherwise.
|
|
|
Sec. 822.34 What must I do with the records if the sponsor of the plan or an investigator in the plan changes?
|
|
If the sponsor of the plan or an investigator in the plan changes, you must ensure that all records related to the postmarket surveillance have been transferred to the new sponsor or investigator and notify us within 10 working days of the effective date of the change. You must provide the name, address, and telephone number of the new sponsor or investigator, certify that all records have been transferred, and provide the date of transfer.
|
|
|
Sec. 822.35 Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?
|
|
We can review your postmarket surveillance programs during regularly scheduled inspections, inspections initiated to investigate recalls or other similar actions, and inspections initiated specifically to review your postmarket surveillance plan. We may also inspect any other person or site involved in your postmarket surveillance, such as investigators or contractors. Any person authorized to grant access to a facility must permit authorized FDA employees to enter and inspect any facility where the device is held or where records regarding postmarket surveillance are held.
|
|
|
Sec. 822.36 Can you inspect and copy the records related to my postmarket surveillance plan?
|
|
We may, at a reasonable time and in a reasonable manner, inspect and copy any records pertaining to the conduct of postmarket surveillance that are required to be kept by this regulation. You must be able to produce records and information required by this regulation that are in the possession of others under contract with you to conduct the postmarket surveillance. Those who have signed agreements or are under contract with you must also produce the records and information upon our request. This information must be produced within 72 hours of the initiation of the inspection. We generally will redact information pertaining to individual subjects prior to copying those records, unless there are extenuating circumstances.
|
|
|
Sec. 822.37 Under what circumstances would you inspect records identifying subjects?
|
|
We can inspect and copy records identifying subjects under the same circumstances that we can inspect any records relating to postmarket surveillance. We are likely to be interested in such records if we have reason to believe that required reports have not been submitted, or are incomplete, inaccurate, false, or misleading.
|
|
|
Sec. 822.38 What reports must I submit to you?
|
|
You must submit interim and final reports as specified in your approved postmarket surveillance plan. In addition, we may ask you to submit additional information when we believe that the information is necessary for the protection of the public health and implementation of the act. We will also state the reason or purpose for the request and how we will use the information.
|
|
|
Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.
Source: 67 FR 38887, June 6, 2002, unless otherwise noted.
|
|
