FDA Issues Order Concerning High-Risk Medical Devices

Kelley Drye Client Advisory

On April 9, 2009, the Food and Drug Administration (“FDA”) published an Order in the Federal Register requiring current manufacturers of 25 categories of class III medical devices to submit data concerning the safety or effectiveness of each manufactured device to FDA by August 7, 2009. Based on the safety information a manufacturer submits to FDA concerning its medical device product, the agency plans to make a determination concerning whether the product must be approved under a PMA or PDP, or whether the class III device can be reclassified as a class I or II device. Since the FDA review could have additional implications affecting tort liability for some companies, affected companies are advised to review their liability risk management plan and insurance coverage in conjunction with these FDA proceedings.


The Medical Device Amendments of 1976 (“1976 Amendments”) to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (“FFDCA”) established a distinctive legal framework with specialized standards and procedures governing FDA regulation of medical device products. On September 6, 1983, the FDA issued a notice stating that as of that date, the FDA had classified 71 preamendments devices into class III, and had proposed that an additional 78 devices be classified into class III in the future. See 48 Fed. Reg. 40,272 (September 6, 1983). As to the timeline, the FDA opined, “[t]he issuance of regulations. . .for all these devices will take many years, given the existing agency resources available for this activity” and noted, “[t]he panels recommended that a high priority be assigned to 63 of the 149 devices classified or proposed to be classified into class III.“

In 1990, Congress passed the Safe Medical Devices Act (“SMDA”) (Pub. L. 101-629). The SMDA requires classification of devices into one of three categories: class I (lowest risk), class II (medium risk), or class III (high risk). The SMDA required the FDA to re-examine class III devices and either reclassify them into class I or II, issue a final regulation requiring Pre Market Approval (“PMA”), or subject them to the Product Development Protocol (“PDP”) process, which is similar to PMA. PMA is a stringent form of review, typically requiring clinical data that provides reasonable assurance that the device is safe and effective. A successful submission results in FDA approval.

On April 19, 1994, the FDA Office of Device Evaluation published a memorandum laying out a strategy to resolve the remaining preamendments class III devices. Specifically, the memorandum noted that as of that date there were 117 remaining preamendments devices for which FDA had initiated no action. Of those, the FDA stated that 42 were believed not to be candidates for reclassification and that therefore they would soon require a PMA submission; 31 were viewed as likely to be reclassified into class II; and 44 had fallen into disuse or limited use, and were unlikely to be reclassified or to require PMA. On May 6, 1994, the FDA issued a notice stating that subsequent to enactment of the SMDA in 1990, the FDA has issued proposed rules to require the submission of PMAs for five devices. See 59 Fed. Reg. 23,731 (May 6, 1994). FDA has made its final determination for all but 27 of the preamendments devices.

The FDA’s April 9, 2009 order pertains to 25 of the remaining 27 categories of class III preamendment devices (see list below). The FDA intends to address the remaining two devices, Herpes simplex virus serological assays (21 C.F.R. § 866.3305) and Topical oxygen chamber for extremities (21 C.F.R. §878.5650), in subsequent orders.

Medical Device Safety Issues

The FDA’s April 9, 2009, order follows a January 2009 report by the Government Accountability Office (“GAO”), a non-partisan investigative arm of Congress, recommending that FDA promptly undertake a full review of certain high risk” medical devices (e.g., preamendment class III devices), which previously received FDA approval pursuant to an abbreviated premarket notification” review process. The GAO report further recommended that the FDA review should result in either a full review and PMA or, if warranted, the reclassification of the device to a lower risk class (class I or II).

The safety of certain currently marketed medical device products also has been questioned by certain stakeholders. For example, in January, a group of FDA scientists raised such concerns in a letter to President Obama’s transition team. In March, a public interest organization raised similar concerns, and contended that a substantial number of class III medical device recalls have been based on malfunctions and other safety issues. Also in March, several groups including the American Association of Retired Persons and the New England Journal of Medicine expressed support for policies ensuring that persons injured by medical devices authorized under the FFDCA would continue to have the right to bring tort claims against manufacturers under state law.

Congressional Bills Pending

Several bills now pending before Congress would amend the medical device provisions of the FFDCA. In February, a bill was introduced in the House of Representatives to amend the FFDCA to provide the FDA more resources to inspect domestic-made devices and foreign-made devices. See H.R. 759, 111th Cong. (2009) (“Food and Drug Administration Globalization Act of 2009”). A similar bill was introduced in the Senate in April. See H.R. 882, 111th Cong. (2009) (“Drug and Device Accountability Act of 2009”).

In March, bills were introduced in the House and Senate that would amend the FFDCA to add the following provision intended to prevent device makers from using FDA approval as a shield against state tort liability: No effect on Liability Under State Law – Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.” H.R. 1346, 111th Cong. (2009); S. 540, 111th Cong. (2009) (“Medical Device Safety Act of 2009” or MDSA”).

Medical Devices Covered By the FDA Order

The FDA Order published on April 9, 2009, applies to manufacturers of the class III medical devices of the types listed below.
Device TypeClassification Regulation (21 C.F.R. § XXX.XXX)Corresponding Product Code(s)1
Membrane lung for long-term pulmonary support868.5610BYS
Intra-aortic balloon and control system870.3535DSP, NKO
Ventricular bypass (assist) device870.3545OKR
External pacemaker pulse generator870.3600DTE
Implantable pacemaker pulse generator870.3610DSZ, DXY
Endosseous dental implant (blade-form)872.3640(b)(2)NRQ
Cardiovascular permanent pacemaker electrode870.3680(b)DTB
Pacemaker programmers870.3700KRG
Pacemaker repair or replacement material870.3710KFJ
Mandibular condyle prosthesis (for temporary reconstruction)872.3960(c)(2)NEI
Nonroller-type cardiopulmonary bypass blood pump870.4360KFM
External cardiac compressor870.5200LIX, DRM
External counter-pulsating device870.5225DRN
Automated external defibrillator870.5310NPN, NSA, MKJ
Implanted blood access device876.5540(b)(1)NIF, MSD, NYU, FJM, FJN, FJO, FJQ, LTH, FIQ, NNF, FKN, FKW, KNR, KNZ, LBW, LFJ
Sorbent hemoperfusion system876.5870FLD
Cranial electrotherapy stimulator882.5800JXK
Electroconvulsive therapy device882.5940GXC
Female condom884.5330OBY
Pedicle screw spinal system (certain uses)888.3070(b)(2)NKB
Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis888.3320JDL, LTO
Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis888.3330KWA
Shortwave diathermy (certain uses)890.5290(b)ILX
Iontophoresis device (certain uses)890.5525(b)EGJ
Transilluminator for breast evaluation892.1990LEK

1The name and product code identify the generic category of a device for FDA. The Product Code assigned to a device is based upon the medical device product classification designated under 21 C.F.R. Parts 862-892.

Submissions Required by the Order

Manufacturers that currently market medical devices of the types covered by the order must make one of two types of submissions to FDA for each such device by August 7, 2009:

(1) If a manufacturer is aware of data that support classification into class I or II, the manufacturer must submit either a formal reclassification petition as described in 21 C.F.R. § 860.123(a)(3), or a submission containing the following information:

A) Identification: A brief narrative description of the device that distinguishes it from a generic type of device;
B) Risks to health: A summary of all adverse safety and effectiveness information not previously submitted under FFDCA section 519, including a description of the mechanisms or procedures intended to control the risk, a list of general hazards associated with the device, and a bibliography containing all referenced material;
C) Recommended reclassification (class I or II);
D) Summary of reasons for reclassification: The rationale behind the recommendation, including a summary of the special controls the manufacturer believes would be adequate;
E) Summary of scientific evidence upon which the recommendation is based.
(2) If a manufacturer concludes that the data do not support reclassification to class I or II, the manufacturer must make a submission containing the following information:
A) Indications for use;
B) Description of device;
C) Other device labeling: indication of contraindications, warnings, and precautions and/or promotional materials;
D) Risks: Summary of all adverse safety and effectiveness data and identification of risks presented, and mechanisms or procedures intended to control the risk;
E) Alternative practices and procedures: Other ways in which the same disease or condition can be diagnosed, treated, or prevented, cured, or mitigated;
F) Summary of preclinical and clinical data: The summary should include the conclusions drawn from the studies, whether positive, negative, or inconclusive. Information should also be provided concerning the purpose and design of the studies, including how data were collected and analyzed;
G) Bibliography: A copy of each major reference and a summary of same, including an explanation of its relevance to safety or effectiveness.
FDA Determinations Based on Submissions

Based on the information a manufacturer submits to FDA concerning its medical device product, the agency plans to make a determination concerning whether the product must be approved under a PMA, or whether the class III device can be reclassified as a class I or II device. If FDA concludes that the safety and effectiveness data submitted by a manufacturer does not support reclassification of the medical device as a class I or II device, FDA will require the device to undergo PMA or in rare cases require compliance with a Product Development Protocol (PDP). Under PDP, the FDA and the manufacturer agree in advance on the device testing program. If the testing program achieves adequate results, the FDA will deem the product to have received PMA. An FDA spokesperson has stated that if a medical device can no longer be authorized by FDA, a product recall could be required. Any safety concerns that are exposed as a result of the review of safety data undertaken by the agency under the FDA order could have adverse liability implications for affected companies, potentially including litigation under state product liability and consumer protection law.

FDA Enforcement

Failure to comply with the FDA order may be subject to one or more of the following:
- seizure or injunction under §§ 302(a) and 304(a) of the FFDCA (21 U.S.C. §§ 332(a) and 334(a));
- civil penalties under § 303(f) of the FFDCA (21 U.S.C. § 333(f)); and
- criminal prosecution under § 303(a) of the FFDCA (21 U.S.C. § 333(a)).
Keys for Managing Liability Risks For Companies Subject to the FDA Order
  • Make a timely submission of all data requested by FDA by August 7, 2009. FDA anticipates no deadline extension.
  • Reduce product liability risks by ensuring that complete and accurate information concerning medical device safety is submitted to FDA for review.
  • Evaluate the adequacy of existing liability risk management plans and insurance coverage with respect to medical device products that are subject to FDA’s April 9, 2009, order.

Kelley Drye & Warren LLP

Kelley Drye’s team of Food and Drug lawyers strives to integrate our clients’ business strategies with FDA compliance and to help resolve regulatory enforcement matters when they arise. Working side-by-side with business development and marketing professionals, we provide comprehensive regulatory counseling and assist in developing products, labels, and promotional materials that achieve our clients’ goals without running afoul of regulatory requirements. With close knowledge of FDA’s enforcement priorities and deep experience with the FTC’s regulation of advertising, our team can provide comprehensive legal advice with an eye towards giving clients a competitive edge.

Kelley Drye’s Government Relations and Public Policy practice helps clients interpret and shape governing laws, enabling them to achieve and maintain market leadership. The Government Relations practice includes attorneys who are both litigators and legislative advocates, as well as non-lawyer legislative professionals who have experience with the legislative and executive branches and the federal agencies. We work closely with the full range of Kelley Drye’s regulatory practice groups, including, but not limited to, antitrust, advertising, consumer product safety, environmental, food and drug, healthcare, international trade, tax and telecommunications and e-commerce.

For more information about this Client Advisory, please contact:

Mark L. Austrian
(202) 342-8495

Dana S. Wood
(202) 342-8608