Post Marketing Survelliance.pptx

21 CFR Part 822 involves the guidelines about the post-marketing surveillance of the under-investigation medical device.

1. Post Marketing Surveillance 21 CFR Part 822 Prachi Sharma M. Pharm. (DRA) I Sem

2. Post Marketing Surveilliance The term Pharmacovigilance is used for the Post Marketing Surveillance of a drug. PMS helps to monitor the side effects of a drug after it has been launched in the market for the use of the patients. PMS is another term used for Pharmacovigilance.

3. Table of Contents Subpart A - General Provisions § 50.1 Scope. § 50.3 Definitions. Subpart B - Informed Consent of Human Subjects § 50.20 General requirements for informed consent. § 50.23 Exception from general requirements § 50.25 Elements of informed consent § 50.27 Documentation of informed consent.

4. Subpart D - Additional Safeguards for Children in Clinical Investigations § 50.50 IRB duties. § 50.51 Clinical investigations not involving greater than minimal risk. § 50.56 Wards.

5. Subpart A: General Provisions § 822.1 What does this part cover? This part implements section 522 of the Federal Food, Drug, and Cosmetic Act (the act) by providing procedures and requirements for postmarket surveillance of class II and class III devices that meet any of the following criteria: Failure of the device that would likely to have serious adverse health consequences device is intended to be implanted in the human body for more than 1 year

6. § 822.2 What is the purpose of this part? to implement our postmarket surveillance authority to maximize the likelihood that postmarket surveillance plans will result in the collection of useful data that can reveal unforeseen ADRs. § 822.3 How do you define the terms used in this part? Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., as amended. Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution Manufacturer Investigator PMS

7. § 822.4 Does this part apply to me? If we have ordered you to conduct postmarket surveillance of a medical device under section 522 of the act, this part applies to you,if the MD’s intended use is any: Implant for more than 1 year Support or sustain life

8. Subpart B: Notification § 822.5 How will I know if I must conduct postmarket surveillance? FDA will send you a letter (the postmarket surveillance order) notifying you of the requirement to conduct postmarket surveillance. FDA will specify the device(s) subject to the surveillance order and the reason for requiring postmarket surveillance of the device under section 522 of the act.

9. § 822.6 When will you notify me that I am required to conduct postmarket surveillance? FDA will notify you as soon as we have determined that postmarket surveillance of your device is necessary, based on the identification of a surveillance question. § 822.7 What should I do if I do not agree that postmarket surveillance is appropriate? Requesting a meeting with the Director, Office of Surveillance and Biometrics Requesting review by the Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee.

10. Subpart C - Post - M arket Surveillance Plan § 822.8 When, where, and how must I submit my postmarket surveillance plan? You must submit your plan to conduct post - market surveillance within 30 days of the date you receive the post - market surveillance order to the following concerned authorities: Center for Biologics Evaluation and Research, FDA Center for Drug Evaluation and Research, FDA Document Mail Center for Radiological Devices

11. § 822.9 What must I include in my submission? Organizational/administrative information: Your name and address Generic and trade names of your device Name and address of the contact person for the submission Premarket application/submission number and device identifiers Description of the device Product codes and a list of all relevant model numbers Indications for use and claims for the device 2. Post-market surveillance plan 3. Designated person information Name, address, and telephone number Experience and qualifications.

12. § 822.10 What must I include in my surveillance plan? The plan objectives Subject of study (humans, animals) Approach or methodology Sample size Data collection plan Consent document IRB approval Content and timing of reports Patient follow up plans Duration

13. § 822.11 What should I consider when designing my plan to conduct postmarket surveillance? You must design your surveillance to address the post - market surveillance question identified in the order you received. § 822.12 Do you have any information that will help me prepare my submission or design my postmarket surveillance plan? Guidance documents that discuss our current thinking on preparing a post - market surveillance submission and designing a post - market surveillance plan are available on the Center for Devices and Radiological Health's website, the Food and Drug Administration main website

14. § 822.14 May I reference information previously submitted instead of submitting it again? Yes, you may reference information that you have submitted in premarket submissions as well as other post - market surveillance submissions, with document and page number. § 822.15 How long must I conduct post - market surveillance of my device? The length of post - market surveillance will depend on the post - market surveillance question identified. It may be of 36 months or more depending on satisfying information.

15. Subpart D - Additional Safeguards for Children in Clinical Investigations § 50.50 IRB duties IRB must review clinical investigations involving children as subjects covered by this subpart D and approve only those clinical investigations that satisfy the criteria described in § 50.51 , § 50.52 , or § 50.53 § 50.51 Clinical investigations not involving greater than minimal risk Any clinical investigation with no greater than minimal risk may involve children as subjects only if the IRB finds that: No greater than minimal risk is present assent of the children and the permission of their parents or guardians

16. § 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects. Such surveillance may involve children if the IRB finds that: Benefits outweigh the risks associated Adequate provisions for assents and permission from parents or guardians

17. § 50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition. Such surveillance may involve children if the IRB finds that: procedure is likely to yield generalizable knowledge about the subjects' disorder or condition Adequate provisions for assents and permission from parents or guardians risk represents a minor increase over minimal risk

18. § 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. Such surveillance may involve children if the IRB finds that: The study might help in understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children The Commissioner of Food and Drugs, after consultation with a panel of experts and determine if the following conditions are fulfilled: clinical investigation will be conducted in accordance with sound ethical principles Adequate provisions for assents and permission from parents or guardians

19. § 50.55 Requirements for permission by parents or guardians and for assent by children. IRB must ensure that adequate provisions are made for assents and permission from parents or guardians determining whether children are capable of providing assent The assent of the children is not a necessary condition for proceeding with the clinical investigation if the IRB determines: That the capability of some or all of the children is so limited that they cannot reasonably be consulted intervention has a direct benefit that is important to the health or well-being of the children

20. IRB may still waive the assent requirement if it finds and documents that: waiver will not adversely affect the rights and welfare clinical investigation involves no more than minimal risk RBI determines the extent of assent from parents of the children: permission of one parent is sufficient permission is to be obtained from both parents Permission by parents or guardians must be documented

21. § 50.56 Wards Children who are wards of the State or any other agency, institution, or entity can be included if such clinical investigations are: Related to their status as wards Conducted in schools, camps, hospitals, institutions IRB must require appointment of an advocate for each child who is a ward: Advocate will serve in addition One advocate for more than one child

22. Advocate must not be with the clinical investigation, the investigator, or the organization Advocate must be an experienced person and works for best interest of the child

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