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Highlights of 1996 CDRH Accomplishments

March 1997

HIGHLIGHTS OF 1996 CDRH ACCOMPLISHMENTS

The Center for Devices and Radiological Health continued to strengthen its program in seven primary areas:

• New Product Review;
• Postmarket Surveillance;
• Enforcement;
• Scientific Research;
• New Regulations;
• External Communications; and,
• Mammography Quality Standards.

Goal:

To increase the efficiency and rigor of product reviews.

Accomplishments FY'96:

• Approved 43 PMAs, 16 more than in FY '95. Twenty four represent significant medical device breakthroughs. The most notable include:
  • Thoratec Ventricular Assist Device System to serve as a bridge to cardiac transplantation;
  • Ultramark 9 High Definition Ultrasound System to aid in differentiating benign from malignant breast lesions;
  • Seprafilm Bioresorbable Membrane to reduce postsurgical adhesions for abdominal, pelvic, or gynecologic surgery;
  • Reliance Urinary Control Insert for the management of stress urinary incontinence in adult women;
  • ThinPrep Processor to replace conventional Papanicolaou (Pap) smear slide preparation; and,
  • Xillix Life-Lung Fluorescence Endoscopy System adjunct to bronchoscopy to locate bronchial tissue suspicious for dysplasia.

• Significantly reduced the review time for 510(k)s:
  -- average 145 days vs. 178 days in FY'95
  -- median 88 days vs. 102 days in FY'95.
  

• Eliminated the 510(k) backlog from 1,894 at the end of FY'93 to zero overdue at the end of FY'96.

• Reduced the total review time for PMA supplements:
  -- 216 days vs. 275 days in FY'95.

• Increased the percentage of original IDEs approved during the first cycle from 57% in FY '95 to 73% in FY '96.

• Issued final "Guidance for Deciding When to Submit a 510(k) for a Change to an Existing Device."

• Reclassified 112 devices from Class II to Class I; exempted them and 12 Class I devices from premarket notification.

• Piloted real-time review for some PMA supplements; review during meetings or teleconferences with the company speeds action on applications.

• Piloted a two-year voluntary program for third-party reviews for selected low and moderate risk devices.

• Issued the final humanitarian use devices (HUDs) regulation and approved a fetal bladder stent to treat urinary tract obstruction in unborn babies under the new regulation.

• Issued 36 guidance documents to assist in preparing PMAs.

• Improved diversity on medical device advisory panels: females now comprise 40% and minorities 32% of the membership.

Goal:

To detect, analyze, and react quickly to problems with devices in use.

Accomplishments:

• Warned health professionals of problems with medical devices:
  1. accuracy problems with some brands of blood glucose test strips for use in home blood glucose meters;
  2. retinal photic injuries from operating microscopes during cataract surgery;
  3. hazards with the use of electric heating pads in nursing homes, hospitals, and at home (jointly with CPSC);
  4. spontaneous combustion in massed patient examination gloves; and,
  5. old cellulose acetate dialyzers that caused major injuries in one center.
• Implemented the User Facility/MDR regulation -- presented a teleconference broadcast to 6,000 sites and explained it in guidance documents for user facilities and manufacturers. Stayed baseline denominator reporting and held open workshop on its usefulness.

• Processed 121,915 adverse event reports vs. 111,155 in FY'95.

• Held public meeting on electronic data interchange (EDI) to obtain feedback on computerized adverse event reporting. Initiated the first phase of EDI (magnetic media) with selected manufacturers and supported development of an approved ANSI X.12 standard for electronic interchange of information.

• Worked closely with ISO, EU, and Global Harmonization Task Force nomenclature and adverse events committees.

• Approved 12 postmarket surveillance protocols.

• Published 18 articles in peer-reviewed journals describing device adverse event reporting, and the epidemiology of medical device use.

Goal:

Prompt and vigorous action against firms that violate the law.

Accomplishments:

• Published the Quality Systems (QS) regulation replacing the Current Good Manufacturing Practices (GMP) regulation. Working with industry, developed a two-stage implementation plan and program to educate industry on the QS regulation.

• With ORA, implemented "Grassroots Initiatives": preannounced inspections, closeout letters, and annotated 483s.

• Initiated a "risk based" inspectional strategy to assure that limited inspection resources are concentrated on highest risk devices.

• Developed a policy establishing criteria and how to deal with firms that reappear on import detention.

• Reached a Cooperative Agreement in conjunction with the Chicago District; it provides for FDA and a major manufacturer to work together and resolve serious GMP deficiencies identified during inspections.

• Supported a 17-state effort to stop the promotion of unapproved hearing aids to elderly Americans -- one firm paid $515,000 at settlement and agreed to reimburse consumers.

• Settled a civil penalty action assessing $650,000 in firm and $50,000 in CEO fines for repeated marketing of products without 510(k)s.

• Issued a moratorium on outdoor laser shows in Clark County, Nevada to halt injuries (i.e. temporary blindness) suffered by airplane pilots. With FAA, addressed the use of laser shows in navigable airspace.

• A US District Judge ordered a permanent injunction requiring compliance with the FD&C Act and assessed $13,000 in fines against a diagnostic X-ray firm and its president.

• A diagnostic ultrasound scanner system owner signed a consent decree to refrain from performing "Keepsake Videos" on the unborn.

Goal:

Develop consensus standards and laboratory studies integral to premarket and postmarket review.

Accomplishments:

• Laboratory studies conducted during the year included:
  --analytical method to quantify leachable chemical accelerators from natural rubber latex;
  --risks of retinal photic injury from intraocular illuminators used during vitreo-retinal surgery;
  --fatigue behavior on flexing of latex barrier films such as surgical and examination gloves; and
  -- adequacy of sterility assurance levels.

• Contributed to 430 consensus standards (236 international) with 36 standards organizations.

• Developed a standardized EM interference testing method for implantable cardiac pacemakers and defibrillators.

• Completed the Immunotoxicity Testing Framework, a systematic approach for evaluating potential adverse immunological effects of medical devices and constituent materials.

• Developed a murine model to investigate immune responses to silicone .

• Completed a quantitative evaluation for computed radiography storage phosphor plates as a candidate image receptor for digital mammography.

• Completed development of a novel method for processing magnetic resonance data in diffuse liver disease with superior spatial resolution and reduced blurring of spectroscopic features.

• Established a quantitative laboratory test of ultrasound image quality to determine human-equivalent threshold resolution at low contrast levels.

• Participated in four interlaboratory studies of standard test method precision and bias for medical device consensus standards.

• Developed two Cooperative Research and Development Agreements:
  1. "Rapid and Uniform Heating of Vitrified Organs" with Organ, Inc., Chicago, Illinois; and
  2. "Testing Human Sera for Total GI and Specific IgE for Detection and Survey of Allergic Disease" with CDRH, CBER, and ORA.

• Delivered 121 presentations and published 139 peer reviewed manuscripts on research results.

Goal:

Develop and revise regulations for clarity to enhance the agency's effectiveness in implementing the law while minimizing the burden on the public.

Accomplishments:

• Quality Systems final rule revising the current good manufacturing practices regulations to add design controls and to harmonize with international standards.

• Final rule establishing procedures for: cease distribution, user notification, and, if necessary, recall orders if continued device distribution would result in serious adverse health consequences.

• Final rule establishing procedures for temporary suspension of approval where a device presents a risk of serious adverse health consequences.

• Final rule for humanitarian use devices (HUDs).

• Proposed rules for quality standards under the Mammography Quality Standards Act (MQSA).

• Proposed rule to allow patients with serious or life-threatening conditions access to promising investigational devices when no comparable alternative treatment exists.

• Proposed rule to regulate analyte specific reagents.

• Proposed rules to require allergenicity warnings on latex containing devices and to require expiration dates on condom labels.

• Reproposal of the rule on annual certification under the medical device reporting (MDR) regulations.

Goal:

Clearly convey the Center's expectations in order to improve the quality of applications and compliance with the law.

Accomplishments:

• Conducted 39 premarketing submission and GMP (QS) workshops addressing more than 9,000 persons.

  Improved access to publications with Facts-on-Demand (Fax # 1-800-899-0381) used 50,000 times in FY 1996 and World Wide Web (http://www.fda.gov/cdrh) with 20,000 hits per month.

• Published manuals on Medical Device Quality Systems, Investigational Device Exemption, and Guidance for Medical Gloves.

• Published "Do It By Design, An Introduction to Human Factors."

• Produced and broadcast teleconferences:
  • Third Party Pilot, 510(k) Program: Recent Changes and Future Directions.
  • Medical Device Reporting (MDR).
  • Annual MQSA and NEXT Update.
  • FDA's Quality System Regulation.

Goal:

Enhance the diagnosis of breast disease through high quality mammography examinations.

Accomplishments:

• Proposed rules published on April 3, 1996; 1,800 letters with 8,000 comments are being analyzed.

• 9,687 of 10,025 facilities are fully certified. The remainder are provisionally certified while becoming accredited or reinstated.

• FDA has trained 250 inspectors who have conducted 15,500 inspections since January 16, 1995.

• Worked with facilities on compliance with the interim standards. About 2% of facilities have serious findings and received a warning letter. During 1996, FDA issued the first sanction: a directed plan of correction.

• Monitored MQSA's impact on mammography quality: documenting improvements in radiation dose and reduction in darkroom "fog" (cloudiness). In 1992, before MQSA, 89 percent of facilities had acceptable phantom image test scores; today 98 percent pass.

• Informed mammography facilities and the public of MQSA requirements:
  • a quarterly newsletter for facilities;
  • presentations at national and regional professional meetings; and,
  • a consumer brochure (publication in cooperation with the Agency for Health Care Policy and Research).

Updated 4/4/1997

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