Opinion

David Jessen appeals from the judgment entered after the trial court granted summary judgment in favor of Mentor Corporation in this product liability action. We affirm.

FACTUAL AND PROCEDURAL BACKGROUND

On October 10, 2003 Jessen had a cancerous testicle removed and replaced with a testicular prosthesis, a class III medical device, designed, manufactured, labeled and sold by “Mentor as the Mentor Saline-Filled Testicular Prosthesis.” The prosthesis, which had been shipped unfilled, was not filled with saline solution prior to implantation as directed in the enclosed instructions. The prosthesis became deformed, causing Jessen pain, and ultimately had to be replaced.

On October 15, 2004 Jessen filed a form complaint against Mentor alleging causes of action for strict liability, negligence and breach of warranty.1 The essence of Jessen’s claims is that Mentor failed to include a warning on the outer packaging of the prosthesis that it must be filled prior to implantation.2 On June 2, 2006 the trial court granted Mentor’s motion for summary judgment on the ground Jessen’s state law claims were preempted by federal law.3

*1484CONTENTIONS

Jessen contends there is a triable issue of fact whether the testicular prosthesis is a class III medical device subject to federal preemption and, even if it is, his claims are not preempted.

DISCUSSION

1. Standard of Review

We review the trial court’s grant of summary judgment de novo and decide independently whether the parties have met their respective burdens and whether facts not subject to triable dispute warrant judgment for the moving party as a matter of law. (Intel Corp. v. Hamidi (2003) 30 Cal.4th 1342, 1348 [1 Cal.Rptr.3d 32, 71 P.3d 296]; Guz v. Bechtel National, Inc. (2000) 24 Cal.4th 317, 334 [100 Cal.Rptr.2d 352, 8 P.3d 1089]; Code Civ. Proc., § 437c, subd. (c).) We also review de novo any underlying issues of statutory construction. (Barner v. Leeds (2000) 24 Cal.4th 676, 683 [102 Cal.Rptr.2d 97, 13 P.3d 704].)

When a defendant moves for summary judgment on the ground there is an affirmative defense to the action, the burden shifts to the plaintiff to show there is one or more triable issues of material fact regarding the defense after the defendant meets the burden of establishing all the elements of the affirmative defense. (Code Civ. Proc., § 437c, subds. (o)(2), (p)(2); Mirzada v. Department of Transportation (2003) 111 Cal.App.4th 802, 806-807 [4 Cal.Rptr.3d 205] [once defendant establishes the existence of an affirmative defense, burden on summary judgment shifts to the plaintiff to produce evidence establishing a triable issue of material fact refuting the defense]; Consumer Cause, Inc. v. SmileCare (2001) 91 Cal.App.4th 454, 468-469 [110 Cal.Rptr.2d 627]; Consumer Cause, at p. 486 (dis. opn. of Vogel (Miriam A.), J.) [“[W]hen a defendant moves for summary judgment based upon an affirmative defense, the defendant has the initial burden of production—that is, to make a prima facie showing in support of its affirmative *1485defense .... Once that is done, the burden shifts to the plaintiff to present evidence sufficient to create a triable issue of fact as to the affirmative defense relied on by the defendant.”]; see also Huynh v. Ingersoll-Rand (1993) 16 Cal.App.4th 825, 830 [20 Cal.Rptr.2d 296].) If lessen’s claims are preempted, Mentor “ ‘has established a complete defense and summary judgment was appropriate.’ ” (Armstrong v. Optical Radiation Corp. (1996) 50 Cal.App.4th 580, 585 [57 Cal.Rptr.2d 763] (Armstrong).)

On review of an order granting summary judgment, we view the evidence in the light most favorable to the opposing party, liberally construing the opposing party’s evidence and strictly scrutinizing the moving party’s. (O’Riordan v. Federal Kemper Life Assurance Co. (2005) 36 Cal.4th 281, 284 [30 Cal.Rptr.3d 507, 114 P.3d 753].)

2. Law Governing Federal Preemption of State Law Claims Involving Medical Devices

The Medical Device Amendments of 1976 (21 U.S.C. § 360c et seq.) (MDA) to the Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), enacted “ ‘to provide for the safety and effectiveness of medical devices intended for human use’ ” (Medtronic, Inc. v. Lohr (1996) 518 U.S. 470, 474 [135 L.Ed.2d 700, 116 S.Ct. 2240] (Medtronic)), classify medical devices into three categories based on the risk they pose to the public. (21 U.S.C. § 360c; Medtronic, at p. 476; Armstrong, supra, 50 Cal.App.4th at p. 585.) Class III medical devices, which pose the greatest risk, are subject to the most stringent controls. (Scott v. CIBA Vision Corp. (1995) 38 Cal.App.4th 307, 315 [44 Cal.Rptr.2d 902] (Scott).) Examples of class III devices include pacemakers (21 C.F.R. § 870.3610 (2007)), silicone inflatable breast prostheses (21 C.F.R. § 878.3530 (2007)) and “solid or gel-filled silicone rubber prosthesis] that [are] implanted surgically to resemble a testicle” (21 C.F.R. § 876.3750 (2007); see Goldsmith v. Mentor Corp. (D.N.H. 1995) 913 F.Supp. 56, 59 [no triable issue of fact whether Mentor large testicular prosthesis, which contained reinforced, molded silicone elastomer, was class III medical device]).4

“Before a new Class III device may be introduced to the market, the manufacturer must provide the [Food and Drug Administration] (FDA) with a *1486‘reasonable assurance’ that the device is both safe and effective. See 21 U.S.C. § 360e(d)(2). Despite its relatively innocuous phrasing, the process of establishing this ‘reasonable assurance,’ which is known as the ‘premarket approval,’ or ‘PMA’ process, is a rigorous one. Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission.” (Medtronic, supra, 518 U.S. at p. 477.) A product’s labeling is also within the purview of the PMA process. (21 U.S.C. § 360e(d)(2)(A), (B), (D); Steele v. Collagen Corp. (1997) 54 Cal.App.4th 1474, 1488 [63 Cal.Rptr.2d 879] (Steele) [“ ‘ “FDA retains rigid control over the entirety of the labeling and packaging of class III products” ’ “the product’s sponsor must submit a proposed label to the FDA for analysis and review prior to gaining PMA for the product”]; accord, Scott, supra, 38 Cal.App.4th at p. 318.)

Once a product has received premarket approval, it may be marketed (Scott, supra, 38 Cal.App.4th at p. 315), but the product is subject to the federal, device-specific requirement of adhering to the standards contained in its individual, federally approved PMA. (See Riegel v. Medtronic, Inc. (2d Cir. 2006) 451 F.3d 104, 118, cert. granted June 25, 2007, _ U.S. ___ [168 L.Ed.2d 725, 127 S.Ct. 3000].) The manufacturer cannot make any changes that may affect the safety or effectiveness of the device without further FDA (Food and Drug Administration) approval. “Any subsequent changes in the product require submission of a PMA supplement application. (21 C.F.R. § 814.39 (1995).)” (Scott, at p. 315.) “While the design or labeling of a device may be changed to enhance the safety without prior approval from the FDA, the manufacturer must submit to the FDA a PMA supplement and obtain acknowledgment from the FDA of receipt of the supplement. (21 C.F.R. § 814.39 (1996).) The device is still subject to withdrawal from the market if the FDA determines any changes have rendered it unsafe or the labeling inadequate.” (Steele, supra, 54 Cal.App.4th at p. 1488.)

The MDA includes an express preemption provision,5 which “prohibits states from imposing ‘any requirement . . . which is different from, or in addition to,’ federal requirements relating to the safety or effectiveness of *1487medical devices intended for human use. (21 U.S.C. § 360k.)”6 (Evraets v. Intermedics Intraocular, Inc. (1994) 29 Cal.App.4th 779, 785 [34 Cal.Rptr.2d 852].) The FDA has promulgated an interpretative regulation providing, “State or local requirements are preempted only when the [FDA] has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific [FDA] requirements.” (21 C.F.R. § 808.1(d) (2007).) A state law requirement may be “established by statute, ordinance, regulation, or court decision” (21 C.F.R. § 808.1(b) (2007)); thus, state common law claims may be preempted by the MDA. (Armstrong, supra, 50 Cal.App.4th at p. 587.)7

A majority of California and federal courts have concluded all state common law claims relating to the safety or effectiveness of a device, other than those based on a violation of FDA requirements, are preempted.8 (See, e.g., Blanco v. Baxter Healthcare Corp. (2008) 158 Cal.App.4th 1039 [although “Medtronic court was fractured[,] . . . five Justices agreed ‘state common-law damages actions do impose “requirements” and are therefore preempted where such requirements would differ from those imposed’ by the *1488MDA”]; Steele, supra, 54 Cal.App.4th at p. 1489 [“state requirements in the form of standards of care or behavior are preempted and cannot form the basis of a state common law claim for damages if they are different from or in addition to the specific federal requirements arising from the PMA process . . .”]; Scott, supra, 38 Cal.App.4th at pp. 318-319 [“[r]ecent cases . . . illustrate the complete preemptive effect of the PMA process on state law tort claims involving inadequate labeling or failure to warn . . .”]; In re Sulzer Hip Prosthesis and Knee Prosthesis (N.D.Ohio 2006) 455 F.Supp.2d 709, 716 & fn. 8 [cases from seven federal circuits “reveal that § 360k(a) preempts almost every type of state law claim that seeks to hold a defendant liable for a PMA-approved medical device; the only exception is a claim that the medical device failed to conform with the FDA requirements prescribed by the PMA”];9 cf. Kanter v. Warner-Lambert Co. (2002) 99 Cal.App.4th 780, 794-795 [122 Cal.Rptr.2d 72] [“substantial similarity between the premarket approval and new drug application processes compels the conclusion that the latter also establishes a federal requirement with respect to labeling that can have preemptive effect . . .” on “conflicting state requirements”].) “The design, manufacture, and labeling of the device, as approved by the FDA as safe and effective after the device has undergone the PMA process, are the specific' federal requirements giving rise to preemption. [Citations.] They constitute a federal regulatory standard of care.” (Steele, at p. 1489.) The FDA has also “unequivocally expressed the opinion that state common law claims such as those [for defective design and manufacture and failure to warn of the alleged defect] against a PMA-approved device are preempted.” (Horn v. Thoratec Corp., supra, 376 F.3d at p. 171 & fn. 13.) “Because the FDA is the federal agency to which Congress has delegated its authority to implement the provisions of the [MDA], the agency is uniquely qualified to determine whether a particular form of state law ‘stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress,’ [citation] and, therefore, whether it should be pre-empted.” (Medtronic, supra, 518 U.S. at p. 496.)

Notwithstanding the weight of authority, Jessen contends this court should follow Armstrong, supra, 50 Cal.App.4th 580, in which Division One of this court held there was no preemption of the plaintiff’s state law claims for *1489negligence, strict liability and breach of warranty arising out of the use of intraocular fluid—a class HI medical device that had completed the PMA process—in cataract surgery. Relying on the exception to preemption in the FDA regulations for “State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g., requirements such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices” (21 C.F.R. § 808.1(d)(1) (2007)) and its understanding of the United States Supreme Court’s decision in Medtronic, supra, 518 U.S. 470, Division One explained, “[T]he state law requirements imposed by the negligence claim (e.g., the duty of a manufacturer to avoid foreseeable dangers in making a product or to inform users of potentially dangerous products of the risks involved) ‘were not specifically developed “with respect to” medical devices.’ [Citation.] Rather, they are ‘requirements of general applicability where the purpose of the requirement relates ... to other products in addition to [medical] devices.’ [Citation.] ‘These state requirements therefore escape preemption . . . because their generality leaves them outside the category of requirements that § 360k envisioned to be “with respect to” specific devices ....’” (Armstrong, at pp. 594-595.) The court further concluded Armstrong’s theory of strict liability was also based on general principles of state tort law that were not specifically developed with respect to medical devices, and thus was not preempted. (Id. at p. 595.)

3. The Trial Court Properly Granted Summary Judgment in Favor of Mentor

a. Jessen’s common law claims are subject to federal preemption

Recognizing that neither the United States nor the California Supreme Court has given a definitive answer to the question raised by this case,10 we conclude our Third District colleagues in Steele, supra, 54 Cal.App.4th 1474, like the majority of other courts that have analyzed the issue, correctly concluded state common law tort actions relating to the safety or effective*1490ness of PMA-approved devices are preempted by the MDA. As the Steele court explained, in his opinion concurring in part and concurring in the judgment Justice Breyer—who cast the critical fifth vote in the five-to-four decision in Medtronic, supra, 518 U.S. 470—departed from the plurality opinion of Justice Stevens to emphasize he was “not convinced that future incidents of MDA pre-emption of common-law claims will be ‘few’ or ‘rare.’ ” (Id. at p. 508 (conc. opn. of Breyer, J.).) Noting that federal preemption was triggered by state imposition of any “requirement” that differs from “federal requirements relating to the safety or effectiveness of medical devices intended for human use” (21 U.S.C. § 360k), Justice Breyer wrote that “[o]ne can reasonably read the word ‘requirement’ as including the legal requirements that grow out of the application, in particular circumstances, of a State’s tort law.” (Medtronic, at p. 504.) Justice O’Connor in her opinion concurring in part and dissenting in part, which was joined by the Chief Justice and Justices Scalia and Thomas, agreed, “If § 360k’s language is given its ordinary meaning, it clearly pre-empts any state common-law action that would impose a requirement different from, or in addition to, that applicable under the FDCA—just as it would pre-empt a state statute or regulation that had that effect.” (Id. at p. 511 (conc. & dis. opn. of O’Connor, J.).) Division One’s decision in Armstrong, supra, 50 Cal.App.4th 580, essentially “ignores Justice Breyer’s statement in Medtronic, that common law standards of care and behavior impose specific requirements, even though the general duty may not.” (Steele, at p. 1487; accord, Blanco v. Baxter Healthcare Corp., supra, 158 Cal.App.4th at p. 1052.) Consequently, Jessen’s state law claims are preempted unless he can demonstrate a triable issue of fact Medtronic failed to adhere to federal regulatory standards.11

*1491b. The testicular prosthesis is a class III medical device

As a threshold matter Jessen contends Mentor failed to establish the testicular prosthesis is a class III medical device because it erroneously cited 21 Code of Federal Regulations part 878.3530(a) (2007), applicable to silicone inflatable breast prostheses, in its moving papers—a mistake also made in a supporting declaration by Clarke Scherff, a Mentor vice-president responsible for the management of new product development through the manufacturing process, including compliance with FDA regulations.12 Mentor and Scherff’s failure to properly cite 21 Code of Federal Regulations part 876.3750(a) (2007), which states “solid or gel-filled silicone rubber prosthes[es] that [are] implanted surgically to resemble a testicle” are class III medical devices, does not create a triable issue of fact whether the Mentor Saline-Filled Testicular Prosthesis at issue in this case is in fact a class III device.13 Scherff set forth sufficient facts in his declaration, independent of the erroneous legal citation, describing the PMA process and establishing the testicular prosthesis is a class III medical device: It could not be sold to the general public without PMA; on January 22, 2002, Mentor submitted a PMA application; and on July 19, 2002, after extensive review by the FDA, the prosthesis received approval and could thus be sold, but only in accordance with the design, manufacture and labeling specifications approved by the FDA. A declaration was submitted by Jeanne Wyatt, a former full-time employee retained by Mentor as a consultant to provide assistance in, among other things, the PMA process, stating essentially the same thing. (Cf. Goldsmith v. Mentor Corp., supra, 913 F.Supp. at p. 59 [brief affidavits from regulatory affairs manager describing testicular prosthesis and stating it was class III medical device sufficient].)

In the trial court Jessen also attempted to dispute the testicular prosthesis qualifies as a class III medical device by noting Mentor had filed a supplement to its PMA, approved on July 28, 2004, to add a warning to the outer packaging that it should be filled with saline prior to implantation. Use of the supplement process, in fact, confirms the testicular prosthesis is a class III medical device. Mentor would not have needed a PMA supplement unless it had previously received FDA authorization through the PMA process applicable to class III medical devices. Indeed, Jessen himself conceded it is such a device, stating in his opposition brief to Mentor’s motion for summary judgment, “Class III devices, of which Mentor’s testicular implant is one, are devices that ‘present a potential unreasonable risk of illness or injury.’ ” (Original underscoring.)

*1492c. There is no triable issue of fact whether the prosthesis complied with FDA labeling requirements imposed through the PMA process

To establish preemption, Mentor was required “to prove, by way of its statement of undisputed facts, that [the testicular implant] was designed, manufactured, and labeled according to the specifications approved by the FDA.” (Steele, supra, 54 Cal.App.4th at p. 1490.) Mentor met its burden by submitting the declarations of Scherff and Wyatt, which included the necessary information regarding compliance with all FDA specifications.14 Jessen, however, contends he presented evidence Mentor did not actually comply with the FDA requirements regarding labeling, thereby creating a triable issue of fact. Objections to the evidence Jessen cites were sustained by the trial court, and those rulings have not been challenged on appeal.15 (See Lopez v. Baca, supra, 98 Cal.App.4th at pp. 1014-1015 [in absence of proper challenge to trial court’s evidentiary rulings, appellate court will consider all affected evidence to have been excluded].) lessen’s evidence in any event fails to raise a triable issue of material fact. The fundamental premise of lessen’s argument is Mentor failed to comply with a labeling requirement imposed on July 28, 2004, more than eight months after he had his surgery. Mentor, however, was not required to satisfy a PMA requirement not yet in effect. (See Scott, supra, 38 Cal.App.4th at p. 321 [“The fact that [the plaintiff] purchased the product in its unmodified form is not relevant to the question of preemption. The record adequately demonstrates that the [product] was subject to class III MDA regulation at the time of the injury and that the FDA had in fact approved the product for marketing, both in its original and in its new improved packaging.”].) Because Jessen has failed to offer any evidence Mentor failed to comply with the labeling requirement in effect when he had his surgery, his claims are preempted; and summary judgment was properly granted in Mentor’s favor.

*1493DISPOSITION

The judgment is affirmed. Mentor Corporation is to recover its costs on appeal.

Woods, J., and Zelon, J., concurred.

A petition for a rehearing was denied February 6, 2008, and the opinion was modified to read as printed above. Appellant’s petition for review by the Supreme Court was denied April 9, 2008, S161203.