FDLI Introduction to Medical Device Law and

Regulation

Other Postmarket Controls

Philip Katz(202) 624-2660pkatz@crowell.com

October 29, 2002Washington, D.C.

2

Device Tracking

FDCA § 519(e) 21 CFR Part 821 (amended effective

May 9, 2002) “Guidance on Medical Device Tracking”

(Jan. 2000)

3

FDCA § 519(e)

Class II or III device Failure likely to have serious adverse

health consequences Intended to be implanted for more than one

year Life sustaining/supporting device used

outside device user facility

4

Additional Factors

Likelihood of sudden, catastrophic failure

Likelihood of significant adverse clinical outcome

Need for prompt professional intervention

5

Device Tracking

To ensure that device can be traced from manufacturing facility to patient

Must be able to locate device quickly Three days for undistributed device Ten days for device distributed to patient

6

Device Tracking

Separate order issued with PMA approval or 510(k) clearance

Methods may vary, but must have written SOPs

Can use outside contractor

7

Device Tracking

Must audit system, to verify that it works and the information is accurate

Must maintain records as long as device is in distribution or use

8

Device Tracking

Distributors (such as hospitals and other user facilities) must track and provide information to the manufacturer

Obligations start/stop at water’s edge Patient can refuse identifying

information

9

Postmarket Surveillance

FDCA § 522 21 CFR Part 822 (effective July 8, 2002) “Guidance on Criteria and Approaches

for Postmarket Surveillance” (Nov. 1998)

10

FDCA § 522

Class II or III device Failure likely to have serious adverse

health consequences Intended to be implanted for more than one

year Life sustaining/supporting device used

outside device user facility

11

Other Criteria

Important unanswered surveillance question

Availability of other postmarket mechanisms

Practicality of surveillance strategies Magnitude of risk

12

Postmarket Surveillance

Limitations of premarket data Shortcomings of MDRs

13

Postmarket Surveillance

Required by FDA order, not necessarily at time of review/clearance

Manufacturer must submit plan in 30 days

FDA has 60 days to judge plan’s adequacy

14

Range of Methods

Literature review Secondary data sets, registries Studies (clinical, non-clinical)

15

Postmarket Surveillance

Can last up to three years Applies to foreign manufacturers Does not apply to devices for export

only Informed consent and IRB

requirements apply

16

Postmarket Surveillance

Interim and final reports Retain records for two years Produce records within three days Records subject to inspection/review

17

Device Promotion

Advertising Not defined, but see drug regulations

Labeling Label and “all other written, printed or

graphic matter . . . accompanying” the device

18

Device Promotion

Misleading FDCA § 201(n) Not just representations made or

suggested, but also material omissions

19

FDCA § 502 – Misbranding

All devices False or misleading labeling (FDCA §

502(a)) Adequate directions for use, adequate

warnings (FDCA § 502(f)) Registration, listing, 510(f)

notice/information (FDCA § 502(o))

20

FDCA § 502 – Misbranding

Restricted devices False or misleading advertising (FDCA §

502(q)) Advertising or “other descriptive matter”

lacks side effects, contraindications (FDCA § 502(r))

21

Device Promotion

Unapproved uses False or misleading statements

22

Unapproved Uses

Promotion of device that is not approved or cleared

Promotion of cleared/approved device for use that is not cleared or approved

Not limited to advertising/labeling

23

False or Misleading Statements

Shared jurisdiction FDA – all labeling, restricted device ads FTC – all other device ads Sort of

24

False or Misleading Statements

Jurisdiction makes a difference Different outlooks Different processes Different results

25

False or Misleading Statements

FDA No clear standard Can look to drug ad regulations Can look to FTC

26

False or Misleading Statements

FTC Identifying the representation Determine whether it’s true and

substantiated

27

FTC

Identify the representation Express and implied claims Intent irrelevant Reasonable interpretation by target

audience

28

FTC

Is the claim true and substantiated? Implied presence of substantiation “Establishment” claims True + false = false

29

Other Issues

Internet First Amendment

FDLI Introduction to Medical Device Law and

Regulation

Other Postmarket Controls

Philip Katz(202) 624-2660pkatz@crowell.com

October 29, 2002Washington, D.C.