FDA regulation for medical devices

FDA regulation for medical devices, U.S regulations

1. FDA REGULATION FOR MEDICAL DEVICES Simrana fathima.M M.Pharmacy (pharmaceutics) Regulatory affairs

2. CONTENT Definitions Classification of devices Level of control Types FDA regulation Establishment registration and device listing Premarket notification 510(k) Introduction substantial equivalence Who must submit 510(k) content of 510(k) when is 510(k) required when is 510(k ) not required De novo classification 2

3. Pre marketed approval introduction content of PMA review of PMA PMA supplement types of PMA supplement IDE(investigational device exemption) Pre marketing requirement labelling label vs labelling Post marketing requirement quality system regulation/GMP Introduction Flexibility to QS regulation Quality system pyramid 3

4. Medical device reporting Mandatory medical device reporting C omplaint file and medical device reporting Reporting an emergency S earching medical device report The final rule Importing medical device. 4

5. WHO REGULATES MEDICAL DEVICE Australia - Therapeutic Goods Administration (TGA) Europe - Certification is obtained from a Notified Body USA - Food and Drug Administration (FDA) Canada - Health Canada China - The State Food and Drug Administration (SFDA) Japan - Ministry of Health Labour and Welfare (MHLW) Brazil - ANVISA INDIA - CDSCO 5

6. FDA The  Food and Drug Administration  ( FDA  or  USFDA ) is a federal agency  of the  united states department of Health and Human service. MEDICAL DEVICES The term “medical devices” includes everything from highly sophisticated computerized medical equipment down to simple wooden tongue depressors. COMPUTERIZED MEDICAL EQUIPMENT -- x-ray machine, ECG machine, pacemaker etc. "an instrument, apparatus, implement, machine , implant, in vitro reagent, or other similar or related article, including a component part, or accessory which comes under the pharmacopeia. 6

7. CLASSIFICATION OF MEDICAL DEVICES 7

8. Device Class and Regulatory Controls 1. Class I General Controls With Exemptions (low risk ) Without Exemptions 2 . Class II General Controls and Special Controls With Exemptions Without Exemptions 3. Class III General Controls, special control and Premarket Approval 8

9. ESTABLISHMENT REGISTRATION AND DEVICE LISTING Establishments required to list their devices include: – manufacturers – contract manufacturers that commercially distribute the device – contract sterilizers that commercially distribute the device – repackagers and relabelers – specification developers –reprocessors of single-use devices –remanufacturers – manufacturers of accessories and components sold directly to the end user – U.S. manufacturers of "export only" devices 9

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11. PREMARKETED NOTIFICATION INTRODUCTION All medical devices must submit premarketed notification, except:- 1.device for which PMA application is required 2.device exempted from 510(K) notification FDA (most class I ). For Device with 510(K) submission manufacturer must receive a clearance order before commercial distribution It takes 90 days to receive clearance or longer typically 130 days ( depends on the information submitted by manufacturer) It should demonstrate that the device to be marketed is as safe and effective as predicate. After 510(K) approval the manufacturer can manufacture the device without waiting for FDA quality system inspection, but submitter must be ready for inspection . 11

12. SUBSTANTIAL EQUIVALENT A device is substantially equivalent only if 1.same use as predicate and same technological characteristic as predicate. 2.same use as predicate but different technological characteristic as predicate. It confirms that safety and effectiveness are adversely effected by new technological characteristics. If FDA determines that the device is not substantially equivalent, the applicant may:- Resubmit another 510(K) Request class I and class II designation through de novo process File reclarification submission Submit a PMA application 12

13. WHO MUST SUBMIT 510(k) Domestic manufacturer, specification developer, foreign manufacturer, must submit 510(K) as they are introducing medical device to:- USA market for 1 st time Proposing a new and different use for device already in commercial use Changing device already in use Repacker or relabeller who modify or change the labelling of medical device. 510(K) regulation do not specify who must apply for 510(K) 13

14. CONTENT OF 510(k) There is no 510(k) form But these contents must be present Device name and class Substantial equivalent comparison to predicate Indication for use Description of device Performance data Compliance with standard Labelling, sterilization and packing 14

15. WHEN IS 510(k) REQUIRED 15 When a device is marketed for the 1 st time, medical device that was not marketed before may 28,1976 for these devices 510(K) is required. Propose different use from that of the predicate. Change or modification in predicate medical device that affects the safety and effectiveness WHEN IS 510(k) NOT REQUIRED If unfinished product or components of devices are sold If distribute another firms device If device is marketed before may 28,1976 If device is from outside US and the exporter already submitted 510(K),then the importer need not submit the 510(K).

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17. De novo classification Also known as automatic class III designation For “low risk” devices with no predicate that are found to be NSE through the 510(k) process Submitter must request de novo classification within 30 days of receipt of NSE The de novo process has a 60 day review period. If FDA grants request the device is permitted to enter commercial distribution in same manner as 510(K) clearance Device in DE novo can be used as a predicate in future 510(k) submission. 17

18. PRE MARKETED APPROVAL INTRODUCTION Mainly applicable for class III devices ( high risk) Applicable for class II if device is not substantially equivalent. Most stringent type of device marketing application FDA confirms premarketed approval only when it confirms the scientific evidence to assure that the device is safe FDA requires 180 days to review or longer PMA- private license permitting the applicant to market the device FDA notifies applicant that PMA is approved or denied, the notice is published on internet also. 18

19. CONTENT OF PREMARKETED APPROVAL Device description and principle of operation Preclinical and clinical studies Bibliography of known information Manufacturing information Professional and patient labelling REVIEW OF PMA TEAM: medical officer, engineer, biologist, statistian, labelling expert, manufacturing expert will review premarketed approval 45 days to file and 180 days to review Advisory committee input is also required 19

20. PREMARKETED APPROVAL SUPPLEMENT TYPES OF PMA SUPPLEMENT 180 DAYS( in depth review) SPECIAL PMA SUPPLEMENT- change being affected 30 DAYS NOTICE AND 135 DAYS PMA SUPPLEMENT ( manufacturing process and method)

21. INVESTIGATIONAL DEVICE EXEMPTION (collection of data) Allows investigational device to be used in clinical study to collect data (safety and effectiveness)required to support a pre marketed approval. Investigational device exemption is important for device which do not get clearance using premarketed approval REQUIREMENTS TO PROCEED WITH INVESTIGATIONAL DEVICE EXEMPTION plan approved by institutional review board (IRB) for high risk Label stating the device is only for investigational use Monitoring of study All records and reports 21

22. PREMARKETING REQUIREMENT LABELLING LABELLING = LABEL+LITERATURE INFORATION OF DESCRIPTION LABEL VS LABELLING label Display of written, printed, or graphical matter upon immediate container Any information appearing on immediate container must also appear on the wrapper. LABELLING All label and other written, printed or graphite matter upon any article or accompanying such articles 22

23. POST MARKETING REQUIREMENT QUALITY SYSTEM REGULATION/GMP INTRODUCTION 23

24. FLEXIBILITY OF QUALITY SYSTEM REGULATION 24 QUALITY SYSTEM PYRAMID

25. MEDICAL DEVICE REPORTING A medical device that cause a death, injury or device malfunction is required to report FDA Helps to detect and correct problem of medical device MANDATORY MEDICAL DEVICE REPORTING 25

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28. COMPLAINT FILE AND MDR Complaint file are linked to medical device reporting file because a complaint must be evaluated to determine if it is a reportable adverse event Complaints may be written, oral, or electronic. Manufacture and importer must maintain complaint file. REPORTING AN EMERGENCY: notify FDA office for crisis management. SEARCHING MEDICAL DEVICE REPORT: FDA maintain the MANUFACTURE AND USER FACILITY DEVICE EXPERIENCE (MAUDE) database. It contains all reports from august 1996-present. 28

29. MDR – FINAL RULE 29 IMPORTING MEDICAL DEVICE Foreign manufacturer, manufacture the device that emit radiation and import to US must comply FDA regulation (before, during and after importing to US).

30. THANK YOU 30