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What should be provided to evaluate the patient exposure to the device or device component chemical(s)? | An exposure assessment for each chemical (including any related impurities) to which the patient has direct or indirect contact |
What can be conducted using the chemical characterization testing methods described above for elution? | this testing |
What is the reason for the information above confirms that there are no toxicity concerns for the device or device component chemical? | the chemical is physically sequestered in a device component with no direct or indirect tissue contact |
What should be provided if the information above suggests that there is patient exposure to the device or device component chemical? | toxicological information |
What is needed unless a scientific rationale is provided to explain why these additional tests are not needed? | null |
What is needed if extractables and/or leachables data demonstrates exposure will be below the Answer: exposure will be below the Answer: Answer: exposure will be below the Answer: Answer: the Answer: the Answer: the Answer: the Answer: the Answer: the Answer: the Answer: the Answer: the Answer: the Answer: the Answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the? | null |
What is the TTC? | if a TI cannot be derived |
What is the Center for Biologics Evaluation and Research? | Center for Devices and 124 Radiological Health |
What is needed to determine how much of the chemical? | further information |
What should be provided to demonstrate the amount of chemical(s) to which the patient may be exposed (e.g., amount released) through 30 days? | null |
What should be provided to demonstrate the amount of chemical(s) to which the patient may be exposed (e.g., through elution)? | null |
What is the ADME? | absorption, distribution, metabolism, and excretion |
What may give users a false sense of security when using a medical device? | Use of such terms may give users a false sense of security |
What does FDA recommend the use of a statement based on? | a material certification |
What does FDA recommend that a sponsor provide to support that the device does not include the material at a level that could result in an adverse event? | data |
What must final labeling comply with before a medical device is introduced into interstate commerce? | 21 CFR Parts 801 and if applicable, 809 |
What is the name of the document that contains Nonbinding Recommendations? | Natural Rubber Latex – Guidance for Industry and Food and Drug Administration Staff |
What is a common endpoint for evaluation of ices? | either additional or fewer endpoints than indicated |
What is the stepwise approach presented below to conduct? | 129 gap analysis |
What is the most informal way to obtain device categorization information? | email |
What is the FDA's guidance document called? | Requests for Feedback and Meetings for Medical Device Submissions: The Q- Submission Program |
What is the duration of contact? | prolonged Category Contact |
What is the Tissue including? | tissue fluids and subcutaneous spaces |
What should be provided for any devices, device components, or materials remaining in contact with tissue that are intended to degrade? | Degradation information |
What is the name of the column in ble A.1 that includes separate columns for subacute and subchronic toxicity endpoints? | ble A.1 |
What is not appropriate to use data from an acute systemic toxicity or implantation study in place of a separate pyrogenicity evaluation? | periodic temperature measurements |
What is the name of the attachment that contains nonbinding recommendations? | Attachment B: Device Master Files for Biocompatibility Evaluations |
What is the name of the chemical component that is hemical in the formulation? | chemical component |
What is the name of the zation method that includes a. Identification of material(s); b. Analysi(e)s for heavy metals; c. Sterilization residuals, if relevant (e.g., ethylene oxide); d. Recommended extraction conditions (solvents, temperatures) and an explanation of such conditions based on material chemistry (e.g., solubility, transition temperature); and f. Results from testing of the mater? | null |
What does the sponsor of a combination product submit to the [FDA] using a risk-based approach and taking into account any prior finding of safety and effectiveness or substantial equivalence for the approved constituent part relied upon by the applicant? | any incremental risks and benefits posed by such combination product |
What is the name of the surface characterization methods recommended for this material? | ISO/TS 10993-19 |
What is the name of the standard that specifies the deviations from the standard? | ISO 10993-5 |
What is the name of the table in Table C.1? | Table C.1 |
What is the name of the document that is used to document the sterilized device? | V2 |
What is a known carcinogen? | Material X |
What is the main chart of the FDA's biocompatibility evaluation? | 49 Contains Nonbinding Recommendations Attachment D: Biocompatibility Evaluation Flow Chart |
What should all test reports address? | reporting provisions of any referenced standards |
What should the test report explain if the test uses extracts? | how those extracts were prepared |
What should the test report provide if the method used is not in a published guidance document or FDA-recognized standard? | a complete description of the method |
What is the name of the FDA's Pilot Program for biocompatibility testing of medical devices? | ASCA |
What should the 136 safety and effectiveness profile include for Combination Product B in comparison with Combination Product A? | a clear, comprehensive listing of the 137 differences in the device constituent part, the drug constituent part, and the combination 138 product as a whole |
What are both compendia and guidance? | ISO 10993 series of standards |
What should be provided for any tests selected under the ISO 10993 paradigm? | the rationale for the test battery selected and the criteria used to determine acceptance |
What should be provided in the test report? | a rationale for the acceptance criteria |
What should the test report include a discussion of? | any test-specific issues that might have affected results |
What should the clinical relevance of the study conclusions be described in? | the test report or in the submission to FDA |
What is the chemical name identical to in the final finished form? | component name |
What is the device identical to? | medical de |
What are some of the chemicals that have not been added to the medical device? | plasticizers, fillers, additives, cleaning agents, mold release agents |
What should a sponsor include in the submission number and date where the legally marketed device was given marketing authorization? | the submission number and date where the legally marketed device was given marketing authorization |
What can be applied to the medical device in its final finished form? | results from the [name] (legally marketed device) |
What is the name of the CADe device that this guidance applies to? | CADe devices |
What are some changes to the local injection adverse reaction profile? | 141 142 |
What could result in a toxic response? | Changes in raw material suppliers or raw material specifications |
What should the sponsor use if there are any formulation changes the sponsor believes will not alter the biocompatibility of the medical device in its final finished form? | null |
What should the sponsor use if there are any formulation changes the sponsor believes will not alter the biocompatibility of the medical device in its final finished form? | componen |
What may result in changes to physical properties and/or surface characteristics of resin? | null |
What qualifier is included in the FDA submission exhibit [#], page [#], submitted on [date]? | null |
What can be applied to the proposed medical device in its final finished form? | results from the test article |
What can be applied to the medical device in its final finished form? | results from the [name] (legally marketed device) |
What may warrant a new risk assessment or new testing if the upper and lower bounds of each component have not been previously evaluated? | Formulation changes that introduce novel components |
What does FDA want to discuss to support their assessment of the medical device? | formulation of the medical device in its final finished form and possible impurities or leachable chemicals |
What is the policy outlined in this Attachment? | a least burdensome76 approach |
What is the approach partially based on? | FDA’s review experience in premarket submissions with these common synthetic polymers and natural fabrics |
What is the 21 CFR 820.70? | Production and process controls for manufacturing |
What is the name of the submission requirements for approval? | safety and effectiveness |
What should manufacturers process complaints in a uniform and timely manner? | cytotoxicity, irritation, or sensitization |
What is the name of the nonbinding recommendations that must be reported to FDA under 21 CFR 803? | 57 |
What does FDA recommend that external stakeholders submit to the docket to suggest the addition or removal of? | device materials or exclusion characteristics |
What should FDA include when suggesting the addition of a material? | identification of the FDA medical device product code(s) where the material is commonly used with intact skin |
What should devices included in the policy outlined in this Attachment meet? | all of the following characteristics |
What is the duration of contact for a long term device? | >30 days |
What is the risk that Neonatal skin and the skin of infants with low birthweight is more permeable? | risk |
What may lead to higher “unsafe” levels of toxicants during pregnancy? | Physiological alterations during pregnancy |
What can animal or plant material cause? | cytotoxicity, irritation, or sensitization |
What is the ABS? | Acrylonitrile-butadiene-styrene plastic |
What can be bridged and leveraged to support approval of Combination Product B? | existing information on Combination Product A 173 can be bridged and leveraged |
What is the name of the nonbinding ingredient that is not used to obtain feedback for combination products? | Polycarbonate |
What is the name of the high density polyethylene? | HDPE |
What is the reason for exclusion Intact skin contacting components There are known risks or we do not have adequate fabricated from materials that are not experience with these materials that may introduce explicitly included in th Policy? | Intact skin contacting components There are known risks or we do not have adequate fabricated from materials that are not experience with these materials that may introduce explicitly included in th Policy: Intact skin contacting components |
What is an increased risk that polymerization or materials? | Fabricated from in-situ polymerizing |
What can introduce a toxicity risk? | The hydrogels manufacturing process |
What can cause adverse biological responses? | Reprocessing of such devices |
What is the only contact with the skin that is used to fabricate the device or component? | direct or indirect skin contact |
What is the name of the section that the FDA recommends that a study be done? | Section D(1)above |
What does FDA recommend that study sponsors describe in IDE progress reports? | any adverse biological responses from devices within this intact skin policy |
What is not necessary to include in a premarket submission? | detailed rationale regarding manufacturing |
What can be reviewed and used to address these gaps under the proposed regulatory pathway as 179 described in Step 5 below? | Not for Implementation 178 |
What has been identified through biocompatibility testing? | cytotoxicity, irritation, and sensitization |
What is FDA’s Recommended Co? | What is FDA’s Recommended Co |
What is the format and content recommendation for certain labeling information related to this policy? | This section contains FDA’s format and content recommendations |
What should caretakers assess patients for on the skin where? | adverse reactions |
What is the term used for a device or device component that comes into physical contact with body tissue? | Indirect contact |
What is the term used for a device or device component that has no direct or indirect contact with the body? | Non-contact |
What is the name of the book that describes the fundamentals of biocompatibility? | Biological Performance of Materials: Fundamentals of Biocompatibility |
What is the risk of a chemical substance or material causing injury or death? | capable of causing injury or death, especially by chemical means |
What is the name of the dictionary that describes the Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process? | null |
What may be challenging or not possible with some combination products 191 because they contain complex constituent parts and/or are likely to be affected by seemingly 192 minor changes.? | null |
What is the part of the risk management process that involves the evaluation and testing of medical devices? | Evaluation and testing |
Who is the Office of Health Technology 8? | Office of Radiological Health |