Bradfor, = Michael, MD, Warning Letter

From: Subject: Bradfor, Michael, MD, Warning Letter Date: Mon, 3 Mar 2008 11:55:32 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_00E0_01C87D25.7BE50E10" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_00E0_01C87D25.7BE50E10 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/s6526c.htm Bradfor, = Michael, MD, Warning Letter

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Department of Health and Human Services	Public Health Service Food and Drug = Administration
	9200 Corporate Blvd, Rockville MID=20 20850

OCT 1 2007

WARNING LETTER

VIA FEDERAL EXPRESS

Michael Bradford, M.D.
Nevada Orthopedic & Spine Center =
2650 N.=20 Tenaya Way, 3rd Floor, Suite 301
Las Vegas, Nevada 89128

Dear Dr. Bradford:

This Warning Letter is to inform you of objectionable conditions = observed=20 during the Food and Drug Administration (FDA) inspection conducted at = your=20 clinical site from February 16 to March 20, 2007, by an investigator = from the=20 FDA San Francisco District Office. The purpose of this inspection was to = determine whether activities and procedures related to your = participation in the=20 clinical study of the [redacted], sponsored by=20 [redacted], in support of PMA = #[redacted],=20 complied with applicable federal regulations. = [redacted] is a=20 device as that term is defined in section 201(h) of the Federal Food, = Drug, and=20 Cosmetic Act (the Act), 21 U.S.C. 321(h). In addition, this letter = discusses=20 your written response to the noted violations, dated April 17, 2007, = postmarked=20 June 20, 2007, and received in the FDA San Francisco District Office on = July 9,=20 2007 and also requests prompt corrective action to address the = violations.

The inspection was conducted under a program designed to ensure that = data and=20 information contained in requests for Investigational Device Exemptions = (IDE),=20 Premarket Approval (PMA) applications, and Premarket Notification = submissions=20 (510(k)) are scientifically valid and accurate. Another objective of the = program=20 is to ensure that human subjects are protected from undue hazard or risk = during=20 the course of scientific investigations.

Our review of the inspection report prepared by the district office = revealed=20 serious violations of Title 21, Code of Federal = Regulations (21=20 CFR), Part 812 -- Investigational Device Exemptions, Part 50 -- = Protection of=20 Human Subjects, and Section 520(g) (21 U.S.C. 360j(g)) of the Act. At = the close=20 of the inspection, the FDA investigator presented an inspectional = observations=20 form FDA 483 for your review and discussed the observations listed on = the form=20 with Ms. Heather Little-Tierney, your study coordinator.

Your response letter addresses each of the FDA 483 items and in most = cases=20 states that no further action is required. You do not describe what, if = any=20 specific steps have been implemented to correct the violations or = prevent future=20 occurrences, or how they will prevent future deviations. In = general, your=20 letter indicates a lack of understanding of the regulatory requirements = that=20 clinical investigators must meet, and it includes few corrective actions = taken=20 or planned, with regard to the deviations noted during the inspection. = It is=20 important for a clinical investigator to understand that unless the = physical=20 safety of a subject demands otherwise, treatment of study subjects must = adhere=20 to the requirements of the investigational plan. The completion of study = enrollment does not conclude your responsibility to comply with the = signed=20 agreement, investigational plan, and applicable FDA regulations for the = study in=20 question. In addition, if you intend to participate in other = FDA-regulated=20 clinical investigations of devices, that participation will be subject = to the=20 same regulatory framework, and so FDA would like to know what corrective = actions=20 you will undertake to prevent similar violations from recurring in the = future.=20 The deviations noted on the FDA 483 and our subsequent review of the = inspection=20 report are discussed below:

1. Failure to obtain informed consent in accordance with = the=20 regulations regarding the protection of human subjects. [21 CFR = 812.100 and=20 50.20]

Pursuant to 21 CFR 812.100, an investigator must ensure that = informed=20 consent is obtained in accordance with part 50. Pursuant to 21 CFR = 50.20, no=20 investigator may involve a human being as a subject in research = covered by=20 these regulations unless the investigator has obtained the legally = effective=20 informed consent of the subject. Examples of your failure to adhere to = the=20 above stated regulation include but are not limited to the following: =

All subjects were screened, randomized into the study, and assigned = study=20 case numbers prior to granting informed consent. In addition, nine = subjects=20 (Subjects # [redacted] and = [redacted]) were=20 screened, randomized into the study, and assigned study case numbers, = although=20 they never consented to participate in the study and did not = participate in=20 subsequent study activities.

In response to this violation, Ms. Little-Tierney told the FDA = investigator=20 that she informed all prospective study subjects of their = randomization to=20 either the control arm or the experimental arm while she was going = through the=20 process of obtaining their informed consent. The protocol specifically = states,=20 "No case will be enrolled without [redacted] Informed = Consent=20 [redacted]"

2. Failure to ensure that an investigation is conducted = according=20 to the signed agreement, investigational plan, and applicable FDA = regulations=20 [21 CFR 812.100 and 812.110(b].

Pursuant to 21 CFR = 812.100 and=20 812.110(b), an investigator is responsible for ensuring that an = investigation=20 is conducted according to the signed agreement, investigational plan = and=20 applicable FDA regulations. You failed to adhere to the above-stated=20 regulations. Examples of this failure include but are not limited to = the=20 following:

a.) Three subjects were enrolled who failed to meet study = eligibility=20 criteria. Specifical Subjects # [redacted], and=20 [redacted] each had a [redacted] = prior to=20 being screened for the study. According to the protocol,=20 [redacted] are to be excluded from the study.

b.) According to the protocol, [redacted]. = Approximately=20 23 percent of all study visits ([redacted] visits) = were=20 outside the acceptable windows. Examples include but are not limited = to the=20 following :

=95The date of [redacted] for Subject=20 #[redacted] was November [redacted] = 2003,=20 and the visit occurred on January [redacted] 2004. =
=95The=20 date of [redacted] for Subject = #[redacted]=20 was November [redacted] 2003, and the=20 [redacted] visit occurred on March=20 [redacted], 2005.
=95The date of=20 [redacted] for Subject# [redacted], = was=20 September [redacted], 2003, and the=20 [redacted] visit occurred on May = [redacted];=20 2006.

3. Failure to maintain accurate, complete, and = current=20 records of each subject's case history and exposure to the device [21 = CFR=20 812.140(a)(3)].

You failed to adhere to the above-stated regulation. Examples of = this=20 failure include but are not limited to the following:

a.) The protocol states that [redacted]' and that=20 [redacted]. At least three subjects had documentation = in=20 their medical records of complications that were not reported to the = study=20 sponsor. Specifically:

=95 For Subject# [redacted], the medical records = for the=20 visit indicate that the subject developed [redacted], but the Physical = Exam=20 case report form indicates there were no complications.
=95 For = Subject=20 #[redacted] the medical records for the=20 [redacted] visit document pain in [redacted]=20 but the Physical Exam case report form indicates there were = no=20 complications.
=95 Subject = #[redacted],experienced=20 [redacted] and examination revealed=20 [redacted] at the=20 [redacted], visit. However, the Physical = Exam case=20 report form lists no complications.

b.) The Screening case report forms for Subjects=20 #[redacted] and [redacted] indicate = that=20 these subjects have no pre-existing [redacted], but, = as noted=20 above in citation 2a, the medical records for these subjects have = multiple=20 entries regarding history of [redacted].

c.) No records were found to verify that any enrolled subjects were = eligible to participate in the study based on the results of the=20 [redacted] evaluation. According to the protocol, = subjects=20 can be included in the study only if they have a = [redacted].=20

d.) All worksheets used to screen the subjects (original source = documents)=20 were discarded after the information was transcribed to case report = form=20 [redacted]. In addition, the sponsor's screening list = indicates that [redacted], subjects were screened at = your=20 clinical site, but Ms. Little-Tierney was only able to find completed=20 screening records for [redacted] subjects.

e.) [redacted] evaluations (two views) were not = available=20 for review by the FDA investigator for Subjects # = [redacted]=20 and [redacted].

The violations described above are not intended to be an = all-inclusive list=20 of problems that may exist with your clinical study. It is your = responsibility=20 as a clinical investigator to ensure compliance with the Act and = applicable=20 regulations.

Within fifteen (15) working days of receiving this letter, please = provide=20 written documentation of the actions you have taken or will take to = correct=20 these violations and prevent the recurrence of similar violations in = current or=20 future studies for which you are the clinical investigator. In addition, = please=20 provide a complete list of all clinical trials in which you have = participated=20 for the last five years, including the name of the study and test = article, the=20 name of the sponsor, the number of subjects enrolled, and the current = status of=20 the study. Failure to respond to this letter and take appropriate = corrective=20 action could result in the FDA taking regulatory action without further = notice=20 to you. In addition, FDA could initiate disqualification proceedings = against you=20 in accordance with 21 CFR. 812.119.

You will find information to assist you in understanding your=20 responsibilities and planning your corrective actions in the FDA = Information Sheets Guidance for Institutional Review Boards and Clinical = Investigators, which can be found at http://www.fda.gov/oc/ohrt/irbs= /=20

We also note that according to Ms. Little-Tierney, all of the = original=20 medical records involved in this study were discarded after they were = scanned.=20 Your response to the FDA 483 indicates that your medical practice = normally=20 operates as a [redacted] office, relying on=20 [redacted] copies of records. Any = [redacted]=20 records you maintain must be sufficient to meet your underlying = recordkeeping=20 obligations. As we noted above, as an investigator, you are required to = maintain=20 accurate, complete, and current records as provided for in 21 CFR = 812.140 (a).=20 You must maintain all required records for a period of two years after = the=20 latter of the following two dates: the date on which the investigation = is=20 terminated or completed, or the date that the records were no longer = required=20 for purposes of supporting a premarket approval application or a notice = of=20 completion of a product development protocol. (See 21 CFR 812.140(d)). = For=20 additional information regarding your obligations when using =
electronic=20 records in FDA-regulated clinical investigations, please see FDA's = Guidance for=20 Industry, Computerized Systems Used in Clinical Investigations, = available at http://www.fda.gov/= cder/guidance/7359fnl.pdf

Any=20 submitted corrective action plan must include projected completion dates = for=20 each action to be accomplished. Send your response to:

Food and Drug Administration, Center for Devices and Radiological = Health=20
Office of Compliance, Division of Bioresearch Monitoring
9200=20 Corporate Boulevard, HFZ-310
Rockville, Maryland 20850 =
Attention:=20 Linda Godfrey, Branch Chief.

A copy of this letter has been sent to the FDA San Francisco District = Office,=20 1431 Harbor Bay Parkway, Alameda, CA 94502. Please send a copy of your = response=20 to that office.

If you have any questions, please contact Ms. Linda Godfrey at (240) = 276-0125=20 or by email at Linda.Godfrey(@fda.hhs.gov.

Sincerely yours,

/S/

Timothy A. Ulatowski
Director
Office of Compliance
Center = for=20 Devices and
Radiological Health

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FDA/Freedom=20 of Information

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