(267 days)
The Oral Matrix is intended for use in extraction sockets only to contain or prevent migration of graft material. The device is supplied sterile and intended for one time use.
The Oral Matrix consists of layered sheets of bioabsorbable extracellular collagen membrane matrix derived from porcine Small Intestinal Submucosa (SIS). These sheets are freeze-dried, packaged in a Tyvek pouch, and sterilized using ethylene oxide to achieve a SAL of 10-6.
The Oral Matrix is available in eighteen different models, the differences between the models are shown in the table below.
| Model | Size (cm) | Tolerance | Thickness |
|---|---|---|---|
| SIS-ORP-4L-1×1 | 1×1 | ||
| SIS-ORP-4L-2×2 | 2×2 | ||
| SIS-ORP-4L-2×3 | 2×3 | ||
| SIS-ORP-4L-3×3 | 3×3 | ||
| SIS-ORP-4L-4×3 | 4×3 | ||
| SIS-ORP-4L-6×6 | 6×6 | ||
| SIS-ORP-4L-1.5×1.5 | 1.5×1.5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-3×5 | 3×5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-2.5×1.5 | 2.5×1.5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-5×4 | 5×4 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-4×6 | 4×6 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-7×7 | 7×7 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-3×3.5 | 3×3.5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-3×7 | 3×7 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-4×4 | 4×4 | ||
| SIS-ORP-4L-5×5 | 5×5 | ||
| SIS-ORP-4L-6×8 | 6×8 | ||
| SIS-ORP-4L-8×8 | 8×8 |
The provided document describes the "Oral Matrix" device and its FDA 510(k) summary, which often includes information on acceptance criteria and supporting studies. However, this specific document focuses on demonstrating substantial equivalence to a predicate device rather than providing explicit acceptance criteria with numerical targets for clinical performance metrics or a detailed standalone study for human-in-the-loop performance. Instead, it relies on non-clinical and animal studies to justify equivalence based on product performance and composition.
Here's an analysis of the provided information concerning acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly list quantitative acceptance criteria in a table format with specific performance targets for the device's intended clinical use (e.g., success rate of socket preservation, bone regeneration metrics). Instead, it presents various non-clinical and animal study findings which implicitly serve as evidence that the device performs similarly to the predicate device or meets regulatory standards.
Implicit "Acceptance Criteria" through Equivalence and Standards Compliance:
| Category | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Product Performance Comparison | Burst Strength: Similar to predicate device. Suture Retention Strength: Similar to predicate device. Tensile Strength: Similar to predicate device. Physical Performance: Similar to predicate device. | "The test results demonstrate the subject device has the similar product performance as those of the predicate device." (No specific numerical values provided for either subject or predicate) |
| Product Composition Comparison | Total Protein Content: Similar to predicate device. Total Sugar Content: Similar to predicate device. Lipid Content: Similar to predicate device. DNA Residue: Similar to predicate device. Peroxyacetic Acid Residue: Similar to predicate device. | "The test results demonstrate the subject device has the similar product composition as those of the predicate device." (No specific numerical values provided for either subject or predicate) |
| Virus Inactivation | Sum of log clearance of DNA and RNA virus from inactivation processes is at least 6 logs greater than anticipated virus concentration in unprocessed animal source (according to ISO 22442-3:2007). | "The test results demonstrate that the virus inactivation processes of the subject device reduce more than 6 logs virus." |
| Package Integrity Testing | Seal Strength: No less than 1.5N/15mm (according to ASTM F88/F88M-15). Dye Penetration: No dye penetration across the package (according to ASTM F1929-15). ASTM F1886: Compliance with standard. | "The test results demonstrate the sterility maintenance package of the subject device meets the requirements of standards and thus provides sterility maintenance for the finished device." (No specific values provided, but compliance stated) |
| Shelf Life Testing | Device safety and effectiveness maintained for the claimed shelf life (24 months) based on package integrity and product performance. | "The test results demonstrate the subject device can claim 24 month as shelf life." |
| Biocompatibility | No negative impacts from materials used (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Pyrogen, Implantation, Subchronic systemic toxicity, Bacterial reverse mutation, Mouse lymphoma TK assay, Hemolysis, Complement activation, Partial thromboplastin time, Chronic system toxicity, Chemical Characterization). | "The test results demonstrate there are no negative impacts from the materials that are used in the subject device." Specific results include: No Cytotoxicity; No Sensitization; No Intracutaneous Reactivity; No Acute Systemic Toxicity; Non irritant after Implantation; No Subchronic Systemic Toxicity; No Bacterial Reverse Mutation; No mutagenic to mouse lymphoma cell; No Hemolysis; Pyrogen meet the acceptable USP limits; No Complement Activation; No Partial Thromboplastin; No Chronic System Toxicity; No unacceptable risks associated with the extract based on the chemical characterization evaluation. (All indicate successful meeting of acceptance criteria for benign biological response.) |
| Animal Study (Performance/Safety) | Ability to preserve the teeth extraction socket, comparable to predicate device and superior to blank control group. | "The results demonstrated that the subject device has ability to preserve the teeth extraction socket compared with predicate device." and "it was similar compared with the predicate device." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Sets:
- Non-Clinical (Product Performance, Composition, Package Integrity, Shelf Life, Biocompatibility): The document doesn't specify sample sizes for these tests. The data provenance is not explicitly stated as country of origin, but the sponsor is Beijing Biosis Healing Biological Technology Co., Ltd. from China, and the testing was likely conducted in a setting compliant with international standards (ISO, ASTM). These are generally prospective tests conducted specifically for the submission.
- Virus Inactivation: Not specified, but likely an in-vitro study designed to demonstrate log reduction, which is a prospective test.
- Animal Study: The sample size for the canine model is not specified. The study was performed in an animal model, which is a prospective study. Data provenance in terms of country is not specified, but usually, animal studies are conducted by or for the submitting company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This section is not applicable as the document describes non-clinical and animal studies, not studies involving human expert interpretation for ground truth. Ground truth for these types of tests is established through laboratory methods and histopathological analysis (for the animal study), not expert consensus on human data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as the studies described (non-clinical, animal) do not involve human interpretation or adjudication processes typical of clinical diagnostic studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done or mentioned. The device is a bone grafting material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. The device is not an algorithm, but a physical bone grafting material. There is no "algorithm only" performance to evaluate. The performance evaluations described are for the physical properties and biological effects of the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Non-Clinical (Product Performance, Composition, Package Integrity, Shelf Life): Ground truth is established by physical and chemical measurements against established standards (e.g., ASTM, ISO guidelines) and comparative data from the predicate device.
- Virus Inactivation: Ground truth is established by virological assays to determine viral load reduction.
- Biocompatibility: Ground truth is established by in vitro and in vivo biological assays (e.g., cytotoxicity, sensitization, implantation responses) adhering to ISO 10993 series standards.
- Animal Study: Ground truth for socket preservation would be established by histopathological examination of the extracted socket sites, potentially including measurements of bone formation, reduction in ridge resorption, and inflammation, compared to control groups.
8. The sample size for the training set
Not Applicable. The device is a bioabsorbable extracellular collagen membrane matrix, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of an AI model.
9. How the ground truth for the training set was established
Not Applicable. As explained above, there is no training set for this type of device.
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February 16, 2024
Beijing Biosis Healing Biological Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co, Ltd. P.O. Box 120-119 Shanghai. 200120 CHINA
Re: K231513
Trade/Device Name: Oral Matrix Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: January 23, 2024 Received: January 23, 2024
Dear Diana Hong:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231513
Device Name Oral Matrix
Indications for Use (Describe)
The Oral Matrix is intended for use in extraction sockets only to contain or graft material. The device is supplied sterile and intended for one time use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K231513
-
- Date of Preparation: 2/16/2024
-
- Sponsor Identification
Beijing Biosis Healing Biological Technology Co., Ltd.
No.6 plant west, Valley No.1 Bio-medicine Industry Park, Daxing District, Beijing, 102600, China.
Establishment Registration Number: 3016668451
Contact Person: Ting Jiang Position: Regulatory Affair Tel: +86-10-61252660 Fax: +86-10-61252030 Email: jiangting@biosishealing.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net
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4. Identification of Subject Device
Trade Name: Oral Matrix
Regulatory Information
Regulation Number: 872.3930 Classification Name: Barrier, Animal Source, Intraoral Classification: II Product Code: NPL; Review Panel: Dental;
Indication for use:
The Oral Matrix is intended for use in extraction sockets only to contain or prevent migration of graft material. The device is supplied sterile and intended for one time use.
Device Description:
The Oral Matrix consists of layered sheets of bioabsorbable extracellular collagen membrane matrix derived from porcine Small Intestinal Submucosa (SIS). These sheets are freeze-dried, packaged in a Tyvek pouch, and sterilized using ethylene oxide to achieve a SAL of 10-6.
The Oral Matrix is available in eighteen different models, the differences between the models are shown in the table below.
| Model | Size (cm) | Tolerance | Thickness |
|---|---|---|---|
| SIS-ORP-4L-1×1 | 1×1 | ||
| SIS-ORP-4L-2×2 | 2×2 | ||
| SIS-ORP-4L-2×3 | 2×3 | ||
| SIS-ORP-4L-3×3 | 3×3 | ||
| SIS-ORP-4L-4×3 | 4×3 | ||
| SIS-ORP-4L-6×6 | 6×6 | ||
| SIS-ORP-4L-1.5×1.5 | 1.5×1.5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-3×5 | 3×5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-2.5×1.5 | 2.5×1.5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-5×4 | 5×4 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-4×6 | 4×6 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-7×7 | 7×7 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-3×3.5 | 3×3.5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-3×7 | 3×7 | ±0.2cm | 0.05~0.13mm |
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| SIS-ORP-4L-4×4 | 4×4 |
|---|---|
| SIS-ORP-4L-5×5 | 5×5 |
| SIS-ORP-4L-6×8 | 6×8 |
| SIS-ORP-4L-8×8 | 8×8 |
5. Identification of Predicate Device
510(k) Number: K161762 Product Name: Dynamatrix/dynamatrix Plus
6. Non-Clinical Test Conclusion
Following non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
Product performance comparison testing
Comparison test has been conducted on the subject device and predicate device, including Burst Strength, Suture Retention Strength, Tensile Strength, Physical Performance, The test results demonstrate the subject device has the similar product performance as those of the predicate device.
Product composition comparison testing
The total protein content, total sugar content, lipid content testing, DNA Residue and peroxyacetic Acid Residue were conducted on the subject device and predicate device. The test results demonstrate the subject device has the similar product composition as those of the predicate device.
Virus Inactivation
In order to demonstrate that the sum of the log clearance of DNA and RNA virus from the virus inactivation processes is at least 6 logs greater than the concentration of virus anticipated in the unprocessed source animal, the sponsor conducted virus inactivation according to o ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents. The test results demonstrate that the virus inactivation processes of the subject device reduce more than 6 logs virus.
Package integrity testing
The package integrity test of the sterility maintenance package was conducted according to ASTM F88/F88M-15, ASTM F1886 and ASTM F1929-15. It include: Flexible Packaging by Visual Inspection: seal strength, which shall no less than 1.5N/15mm, and dye penetration, which shall no dye penetration cross the package. The test results demonstrate the sterility maintenance package of the subject device meets the requirements of standards and thus provides sterility maintenance for the finished device.
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Shelf life testing
In order to ensure the safety and effectiveness of the subject device in the shelf life, package integrity and product performance testing was conducted on the real-time aged device. The test results demonstrate the subject device can claim 24 month as shelf life.
Biocompatibility testing_
The following biocompatibility testing was conducted and the test results demonstrate there are no negative impacts from the materials that are used in the subject device.
Cytotoxicity (ISO 10993-5),
Sensitization (ISO 10993-10),
Intracutaneous reactivity (ISO 10993-23),
Acute systemic toxicity (ISO 10993-11),
Pyrogen (ISO 10993-11),
Implantation (ISO 10993-6),
Subchronic systemic toxicity (ISO 10993-11),
Bacterial reverse mutation test (ISO 10993-3),
Mouse lymphoma TK assay (ISO 10993-3),
Hemolysis study (ASTM F756),
Complement activation (ISO 10993-4),
Partial thromboplastin time (ISO 10993-4).
Chronic system toxicity (ISO 10993-11)
Chemical Characterization (ISO 10993-18, ISO 10993-17).
Animal study
The animal study was performed on a canine model to evaluate the performance and safety by comparing with the predicate device. The results demonstrated that the subject device has ability to preserve the teeth extraction socket compared with predicate device.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
-
- Summary of Technological characteristics
| ITEM | Subject Device | Predicate DeviceK161762 | Remark |
|---|---|---|---|
| Product code | NPL | NPL | Same |
| Class | Class II | Class II | Same |
Table 1 Comparison of Technology Characteristics
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| Indication for Use | The Oral Matrix is intendedfor use in extraction socketsonly to contain or preventmigration of graft material.The device is suppliedsterile and intended for onetime use. | DynaMatrix is intended foruse in guided tissueregeneration and boneregeneration procedures. Itmay be used for boneregeneration and healing ofperiodontal defects, forgingival augmentation, tomaintain or enhancealveolar ridges, or tocontain or prevent migrationof graft material. The deviceis supplied sterile andintended for one-time use. | Different |
|---|---|---|---|
| Sterile | Yes | Yes | Same |
| Sterilization method | EO | EO | Same |
| Single use | Yes | Yes | Same |
| Material | Porcine small intestinalsubmucosa | Porcine small intestinalsubmucosa; primarilycollagen types I and III | Same |
| Drying method | Freeze-dried extracellularmatrix | Freeze-dried extracellularmatrix | Same |
| Absorbable | Yes | Yes | Same |
| Intended for Prescriptionuse only? | Yes | Yes | Same |
| Target population | Human, oral, periodontal | Human, oral, periodontal | Same |
| Location of intendedapplication | Setting appropriate for oralsurgery | Setting appropriate for oralsurgery | Same |
| Packagingconfiguration | Tyvek Pouch | Tyvek Pouch | Same |
| Sizes | 1 cm² to 64 cm²(From 1cm×1cm to8cm×8cm) | 2 cm² to 12 cm² | Different |
| Thickness (mm) | 0.05mm~0.13mm | 0.05mm~0.13mm | Same |
| Biocompatibility | No CytotoxicityNo SensitizationNo IntracutaneousReactivityNo Acute Systemic ToxicityNon irritant after | Comply with ISO 10993series standards |
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| Implantation |
|---|
| No Subchronic SystemicToxicity |
| No Bacterial ReverseMutation |
| No mutagenic to mouselymphoma cell |
| No Hemolysis |
| Pyrogen meet theacceptable USP limits. |
| No Complement Activation |
| No Partial Thromboplastin |
| No Chronic System Toxicity |
| No unacceptable risksassociated with the extractbased on the chemicalcharacterization evaluation |
Different-Indications for Use
The indications for use of subject device is covered by the indications for use of the predicate device. Based on the animal study, the results demonstrated that the subject device has ability to preserve the teeth extraction socket compared with the blank control group and it was similar compared with the predicate device. Therefore, this item is considered substantial equivalent.
Different- Sizes
The size of the subject device is different from the predicate device. However, the test results of product performance comparison testing (burst strength, suture retention strength, tensile strength and physical performance) and product composition comparison testing(total protein content, total sugar content and lipid content, DNA residue and peroxyacetic acid residue) show the performance and composition of the subject device and predicate device have no statistical difference. The difference will not affect the safety and effectiveness of the subject device.
9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is substantially equivalent to the legally marketed predicate device K161762.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.